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© 2021 James H. Botkin dba BotkinChemie Page 1 of 22
Substitution of Benzotriazole UV Absorbers in Plastics: April 2021 Update
James H. Botkin dba BotkinChemie, Madison, NH*
Original version presented at the
SPE Thermoplastic Elastomers Conference, September 2018, Akron, OH
Abstract
Benzotriazole UV absorbers such as UV-328 have been extensively used as light stabilizers
in plastics and coatings for many years. However, increased regulatory compliance burdens
associated with designation of some products (including UV-328) as Substances of Very High
Concern (SVHC) in Europe are driving additive users around the world to phase-out their use by
substitution with safer alternatives. This paper discusses how UV-328 and other benzotriazoles
came to be classified as SVHC under REACH, and identifies potentially safer substitutes for
additive users based on the results of a hazard assessment.
Introduction
Benzotriazole UV absorbers are widely used as light stabilizers in plastics and coatings,
functioning by competitive absorption of harmful UV radiation. These useful additives feature
broad absorbance coverage over both the UV-A (l = 315-400 nm) and UV-B (l = 280-315 nm)
regions, minimal absorbance of visible light (l > 400 nm), and excellent long-term photo-stability.
Benzotriazoles represent a versatile chemical platform in that products having a wide range of
secondary properties (physical form, melting point, volatility) have been developed and are
commercially available. However, new regulatory developments in Europe are creating
considerable pressure for phase-out or substitution of some products, including the widely used
UV-328.
This paper seeks to address the following questions associated with the regulation and
substitution of benzotriazole UV absorbers:
1. What exactly is happening and what are the implications?
2. What products are affected by regulatory developments?
3. Why are some products being regulated?
4. Will other products be regulated in the future?
5. How can better substitutes be identified?
6. How to formulate in new applications to minimize risks?
This updated (4/2021) version of the paper includes a reassessment of the benzotriazole UV
absorbers based on new bioaccumulation data and regulatory developments since the original
paper was written and presented in 2018. New content is given in red.
Affected Products, Status, & Implications
The subject products of this paper are ten different commercially available, solid benzotriazole
UV absorbers that have been historically been used as light stabilizers in plastics and coatings
applications. The common names (based on the Ciba product nomenclature), chemical names,
CAS numbers, and chemical structures are provided in Table 1.
	
* E-mail: jim@botkinchemie.com
© 2021 James H. Botkin dba BotkinChemie Page 2 of 22
In 2014-2015, four of these substances (UV-320, UV-327, UV-328, and UV-350) were placed
on the Candidate List of Substances of Very High Concern (SVHC) by the European Chemicals
Agency (ECHA).[1] The basis for this development was the identification of these substances as
Persistent, Bioaccumulative, and Toxic (PBT) and/or very Persistent and very Bioaccumulative
(vPvB). Under the REACH regulation, there is a duty to communicate information on these
substances and other SVHC present above a cut-off concentration (0.1% by weight) in articles,
preparations, and chemical products.[2] Producers and importers of articles containing SVHC
may also need to submit a notification to ECHA. The increased regulatory burden associated
with the designation of these substances as SVHC has pressured additive users to begin phasing
out their use by substitution with functionally equivalent alternatives.
In February 2018, ECHA recommended addition of UV-320, UV-327, UV-328, and UV-350 to
the REACH Annex XIV List (“Authorisation List”),[3] and these substances were formally listed in
February 2020.[3a] This represents a more serious regulatory development. Once added to the
Authorisation List, companies wanting to continue using these substances are required to apply
for authorization with ECHA no later than May 27, 2022 in order to continue existing uses. These
substances are also subject to a sunset date of November 27, 2023, after which they cannot be
used without authorization. This development has placed additional pressure on additive users
worldwide to phase-out the use of these products. The issue is particularly acute for UV-328,
which is a high volume product widely used in the plastics and coatings industries.
Other benzotriazole UV absorbers (including UV-P, UV-234, UV-326, UV-329, and UV-928)
are also under scrutiny by ECHA as part of the REACH regulation. Specific activities include
evaluation of REACH registration dossiers, substance evaluation in the Community Rolling Action
Plan (CoRAP), assessment of PBT properties, and Regulatory Management Option Analysis
(RMOA). The activities are summarized in the Public Activities Coordination Tool
(PACT).[4,4a,4b,4c,4d,4e] ECHA cautions that these activities only mean that a Member State
or ECHA is examining a substance, not that it actually has PBT properties or that there is need
for regulatory risk management actions.[5] For any substance being assessed, the outcome may
well be that it is not found to have PBT properties based on available data. However, the fact that
these potential alternative products are being scrutinized makes it more difficult for additive
formulators to identify appropriate alternatives to UV-328.
As part of the review of REACH registration dossiers, new bioaccumulation tests were ordered
for UV-P, UV-234, UV-326, and UV-329.[4a,4b,4c,4d]. The new test results for UV-234 and UV-
329 were included in the original version of this paper. The new results for UV-P and UV-326
were published in 2020 and are included in this updated version. The results for UV-326 are
particularly noteworthy as they demonstrate a very high tendency to bioaccumulation (vB).[17]
UV-P was evaluated by the Czech Republic under CoRAP in 2016 with the conclusion that
there was no need for regulatory follow up action at the EU level.[4a] However, this evaluation
did not consider its PBT/vPvB properties.
PBT property assessments and RMOA have been initiated by EU member states for UV-P,
UV-234, UV-326, UV-329, and UV-928.[4a,4b,4c,4d,4e] As of April 2021, none have been
completed.
In Japan, UV-320 came under regulation as a Class I Specified Chemical Substance in 2007
under the Chemical Substances Control Law (CSCL).[6] Class I Specified Substances are
regulated based on being found to be persistent, highly bioaccumulative and posing a risk of long-
term toxicity to humans or animals. Under the CSCL, prior permission is required for manufacture
and/or import, which constitutes a virtual prohibition except for uses designated as essential. UV-
© 2021 James H. Botkin dba BotkinChemie Page 3 of 22
327 and UV-350 are regulated under the CSCL as Monitoring Chemical Substances based on
concerns regarding persistence and bioaccumulation.[7] For these substances, annual reporting
is required if volumes of manufacturing or import are greater than 1 ton per year. The authority
may also order manufacturers and importers to investigate long-term toxicity for humans or
animals. None of the other benzotriazole UV absorbers listed in Table 1, including UV-328, are
subject to restrictions in Japan under CSCL.
In the USA, none of the benzotriazole UV absorbers listed in Table 1 have been subject to
hazard assessments by the EPA under the Toxic Substances Control Act (TSCA) Work Plan [8-
9], risk evaluations under amended TSCA,[10,10a], or TSCA section 6(h) rules related to
persistent, bioaccumulative, and toxic (PBT) chemicals.[10b] According to information in the
EPA Substance Registry,[10c] all of the benzotriazole UV absorbers listed in Table 1 are listed
on the TSCA inventory as Active Substances, and none are subject to special requirements under
TSCA (including consent orders, significant new use rules, test rules, and export notification
requirements).
UV-234, UV-320, UV-328, and UV-329 have been listed as chemicals of concern at the State
level (CA, ME, MN) but are not currently subject to regulation.[10d,10e,10f]
In Canada, a screening assessment was completed by Environment and Climate Change
Canada and Health Canada for UV-328 in 2016 with no further action recommended.[11] Several
other substances listed in Table 1 (UV-234, UV-326, UV-329, and UV-350) met the criteria for
screening under the Canadian Environmental Protection Act (CEPA) and may possibly be subject
to screening assessments in the future. None of the benzotriazole UV absorbers listed in Table
1 are subject to special regulation under CEPA, for example by listing on the export control list,
the priority substances list, list of toxic substances, the virtual elimination list, or the non-statutory
list.[11a]
While no regulatory actions on UV-328 are pending in the USA, Japan, or Canada, the
importance of Europe in global supply chains continues to provide incentive to additive
formulators around the world to replace it with safer alternatives. As part of the search for
alternatives, it’s helpful to understand the reasons behind the regulatory issues associated with
UV-328, UV-327, UV-320, and UV-350.
Rationale for Regulation: Persistence, Bioaccumulation, & Toxicity
As described in the previous section, benzotriazoles are subject to regulatory scrutiny based
on concerns over their persistence, bioaccumulation, and toxicity. Chemicals known to be
persistent, bioaccumulative, and toxic (PBT); or very persistent and very bioaccumulative (vPvB)
are of particular concern for regulators since they can remain in the environment for a long time
and can bioaccumulate in animal tissues. Over time, releases of these chemicals have the
potential to accumulate to higher levels and may cause significant adverse impacts on human
health and/or the environment.
Persistence is defined as resistance of a chemical substance to environmental degradation
through natural chemical, biological, and photolytic processes. This can be inferred through
monitoring studies in water, soils, and sediments. Benzotriazoles were first recognized as
persistent based on monitoring studies conducted on sediments from locations near a former
production site for UV-327 and UV-328 in Rhode Island.[12] Regulators often assess the
persistence of a chemical substance by its degradation half-life times (T1/2) in water, sediment,
and soil, which can be determined by laboratory tests or the use of molecular modeling software.
The criteria for designation of substances as persistent (P) and very persistent (vP) are set forth
© 2021 James H. Botkin dba BotkinChemie Page 4 of 22
in Annex XIII of the REACH regulation.[13] In general, chemicals meet the criteria for vP under
REACH if their T1/2 in water is greater than 60 days and/or greater than 180 days in soil or
sediment. In the USA, the EPA has adopted similar criteria, and a chemical is characterized as
vP if its T1/2 in water, soil, or sediment is greater than 6 months.[14]
Based on information contained in the REACH dossiers [15-22] and the Candidate List
documentation [1] all of the benzotriazole UV absorbers listed in Table 1 are considered to meet
the criteria for vP under the REACH criteria, and would probably be characterized as vP under
the EPA criteria as well.
Bioaccumulation is defined as the tendency of a chemical substance to accumulate in living
organisms. This can be inferred through monitoring studies in wildlife or in humans.
Benzotriazole UV absorbers were first detected in monitoring studies conducted with marine
organisms in Japan,[23] and benzotriazole UV absorbers have since been found in monitoring
studies conducted with marine life in other parts of the world.[24-27] Regulators usually assess
then tendency of a substance to bioaccumulate using Bioconcentration Factor (BCF) or
Bioaccumulation Factor (BAF) values, which are determined by laboratory tests or through the
use of molecular modeling software. The criteria for designation of substances as
Bioaccumulative (B) and Very Bioaccumulative (vB) are set forth in Annex XIII of the REACH
regulation.[13] In general, substances having a BCF value greater than 2,000 are considered to
be B, and those having a BCF value greater than 5,000 are considered to be vB. In the USA, the
EPA considers a substance to be B if its BCF or BAF value is greater than or equal to 1,000, and
vB if its BCF or BAF value is greater than or equal to 5,000.
Based on BCF data contained in the REACH dossiers [17,18] and candidate list
documentation [1], UV-320, UV-326, UV-327, UV-328, and UV-350 all meet the REACH and EPA
criteria for vB. Additionally, the BCF values for UV-P [15], UV-234 [16] and UV-928 [22] meet the
EPA criterion for B (although they do not meet the REACH criterion for B). The remaining
substances (UV-329 and UV-360) are not considered to be B under either REACH or EPA criteria
based on BCF values less than 1,000.[19-21]
Toxicity is defined as the degree to which a substance can damage an organism. Toxicity
and eco-toxicity are assessed using test methods based on the UN Globally Harmonized System
(GHS) of hazard classification. The criteria for designation of a substance as toxic (T) are set
forth in Annex XIII of the REACH regulation. Benzotriazoles present varying degrees of chronic
toxicity and chronic aquatic toxicity. Based on data contained in the REACH dossier [18] and
candidate list documentation [1], UV-320 and UV-328 are considered T under REACH criteria.
The remaining substances (UV-P, UV-234, UV-326, UV-327, UV-329, UV-350, UV-360, and UV-
928) do not meet the REACH criteria for T based on candidate list documentation [1] or the
REACH dossiers.[15,17,19-21]
As defined under the REACH regulation, UV-320, UV-327, UV-328, and UV-350 are all
considered to be PBT and/or vPvB substances, and this can be regarded as the root cause for
placing them on the Authorisation List. UV-326 can be considered to be a vPvB substance based
on available data, and as such may be subject to future listing on the Candidate List of SVHC in
the EU. The remaining products (UV-P, UV-234, UV-329, UV-360, UV-928) do not meet the
criteria for either PBT or vPvB based on available data, but all can be regarded as being very
Persistent (vP) and presenting varying degrees of bioaccumulation and toxicity. However, as the
criteria for bioaccumulation and toxicity used by regulators may be subject to change, additive
formulators may desire to lower the risk of making a regrettable substitution by selecting
© 2021 James H. Botkin dba BotkinChemie Page 5 of 22
alternatives based on their bioaccumulation and toxicity characteristics, for example through a
hazard assessment.
Identifying Safer Alternatives Using Hazard Assessments
Hazard assessments represent part of a larger alternatives assessment process, which
addresses other factors such as technical performance, cost, commercial availability, and
environmental life cycle attributes. Through the use of hazard assessments, users of chemicals
can select safer alternatives and avoid replacing one hazardous substance with another. In the
case of the benzotriazole UV absorbers, a hazard assessment is intended to support informed
decision-making by additive formulators and end users by providing a basis to rank the
attractiveness of alternatives based on their inherent hazard characteristics.
Some hazard assessment methods utilize numerical ratings or benchmarks in order to
facilitate comparisons between different alternatives. The best methods are based on criteria
developed by or consistent with those used by regulatory agencies for evaluating chemical
hazards, for example the UN Globally Harmonized System of Classification and Labeling of
Chemicals (GHS) and the EPA Design for the Environment Program Alternatives Assessment
Criteria for Hazard Evaluation (DfE).
Numerous hazard assessment methods have been developed. Examples include:
• GreenScreen® for Safer Chemicals (“GreenScreen®)•
• GreenScreen List Translator™
• Quick Chemical Assessment Tool (QCAT)
• EPA TSCA Work Plan Chemical Scoring
GreenScreen® is a hazard assessment method developed by the NGO Clean Production
Action, that is designed for use by businesses, government agencies, and certification bodies to
identify chemicals of high concern and safer alternatives.[28-29] This comprehensive method
expands on the GHS and DfE methods, with a full GreenScreen® assessment covering human
health and environmental effects data for a chemical substance based on 18 different hazard
endpoints (carcinogenicity, mutagenicity/genotoxicity, reproductive toxicity, developmental
toxicity, endocrine activity, acute human toxicity, respiratory sensitization, skin
irritation/corrosivity, eye irritation/corrosivity, acute aquatic toxicity, chronic aquatic toxicity,
neurotoxicity, systemic toxicity/organ effects, skin sensitization, persistence, bioaccumulation,
physical reactivity, and flammability). Based on the results of the assessment, chemical
substances are assigned one of five benchmark scores: Benchmark-1 (avoid – chemical of high
concern), Benchmark-2 (use but search for safer substitutes), Benchmark-3 (use but still
opportunity for improvement), Benchmark-4 (prefer – safer chemical), or Benchmark U (not
classifiable due to lack of data). The benchmark scoring makes the comparison of the hazards
associated with different alternatives a straightforward exercise. Use of the GreenScreen®
method would provide the most authoritative differentiation between the benzotriazole UV
absorbers under consideration. However, due to its comprehensive nature, GreenScreen®
assessments are inherently time consuming, and specialized training is recommended for
personnel prior to conducting assessments. For this reason, simpler methods may be appropriate
for a preliminary screening.
The QCAT is a simplified hazard assessment method developed by the Washington State
Department of Ecology with the support of Clean Production Action.[30] This method utilizes a
	
•
	GreenScreen® and GreenScreen List Translator™ are trademarks of Clean Production Action.
© 2021 James H. Botkin dba BotkinChemie Page 6 of 22
smaller number of hazard endpoints (carcinogenicity, mutagenicity/genotoxicity, reproductive
toxicity, developmental toxicity, endocrine activity, acute mammalian toxicity, acute aquatic
toxicity, persistence, and bioaccumulation) and data sources than GreenScreen® to reduce the
number data sources and time required to complete an assessment. Based on the results of the
assessment, chemical substances are assigned one of four grades: A (high concern, avoid), B
(moderate concern, use but search for safer alternatives), C (slight concern, improvement
possible), or D (few concerns, preferable). This method is recommended for use to screen
chemicals to determine whether a more in-depth assessment such as GreenScreen® is
necessary. In the case of the benzotriazole UV absorbers, the downside of this method is that it
does not cover known hazards such as chronic toxicity and chronic aquatic toxicity.
The GreenScreen List Translator™ screening tool developed for the rapid identification of
chemicals of high concern.[31] The method scores chemical substances based on information
from hazard lists developed by authoritative scientific bodies around the world. The results are
used to assign one of three List Translator scores: LT-1 (indicating the presence of a chemical
on at least one authoritative hazard list expected to result in a Benchmark-1 score if further
assessed with GreenScreen®), LT-P1 (indicating presence of a chemical on at least one hazard
list that may possibly result in a Benchmark-1 score upon further assessment with GreenScreen®),
or LT-UNK (indicating that the chemical is present on one or more lists but does not meet any of
the criteria to assign an LT-1 or LT-P1 score). If no information is found for a chemical in any of
the hazard lists, the substance is assigned a score of “NoGSLT”. GreenScreen List Translator™
scores can be determined easily and quickly using online services such as the Pharos Chemical
and Material Library from the Healthy Building Network NGO.[32] While the method is suitable
for the identification of chemicals of high concern, more comprehensive methods such as
GreenScreen® are more appropriate for use in the identification of safer alternatives.
The TSCA Work Plan Chemical Scoring method is used by the EPA to identify potential
candidate chemicals for assessment under TSCA.[33] Chemicals are evaluated and given a
score based on three characteristics: Hazard, Exposure, and potential for Persistence and
Bioaccumulation. The Hazard and Persistence/Bioaccumulation Scores are derived from the
EPA DfE criteria based on 12 different endpoints (acute toxicity, carcinogenicity, mutagenicity/
genotoxicity, reproductive toxicity, developmental toxicity, neurotoxicity, chronic toxicity,
respiratory sensitization, acute aquatic toxicity, chronic aquatic toxicity). While this screening
process is intended mainly to support initial decisions by the EPA to determine the relative priority
of chemicals for further assessments, the Hazard and Persistence/Bioaccumulation Scores are
suitable for use as the basis for a simplified hazard assessment to identify chemicals of concern
and make a preliminary screening of alternatives. Note that the Exposure Score relates to risks
rather than the inherent hazards of a chemical substance, and therefore is not appropriate for
inclusion in a hazard assessment.
Please note that the quality and reliability of any hazard assessment is a function of the data
on which it is based, and is also subject to change as new data is generated. In the author’s own
experience, a GreenScreen® assessment of bumetrizole (UV-326) was prepared in 2015, which
resulted in a benchmark score of Benchmark-2 (use but search for safer substitutes).[34] As part
of the dossier evaluation process under REACH, ECHA proposed new bioaccumulation tests for
the substance in 2019,[4c] which were completed and added to the dossier in 2020.[17] The new
data indicated that the substance has a very high tendency to bioaccumulate (BCF = 6,356–
7,093), and applying this data in the GreenScreen® assessment results in a benchmark score of
Benchmark-1 (avoid – chemical of high concern). The key learning here is the importance of
keeping assessments up to date by monitoring new testing developments, particularly for
© 2021 James H. Botkin dba BotkinChemie Page 7 of 22
substances for which new testing is pending under REACH (testing proposals) or TSCA (test
orders).
Hazard Assessment Screening of Benzotriazole UV Absorbers
A modified version of the EPA’s TSCA Work Plan Chemical Scoring method was used to
make a preliminary assessment of six different benzotriazole UV absorbers (UV-P, UV-234, UV-
326, UV-329, UV-360, and UV-928) as alternatives to UV-328. The method criteria [33] were
applied using data and interpretations from the EU REACH dossiers [15-22] to obtain the Hazard
and Persistence/Bioaccumulation scores. The alternatives were ranked based on the Total
Score, which was defined as the sum of the Hazard and Persistence/Bioaccumulation Scores.
Hazard Scores were assigned for UV-328 and the alternatives based on 10 different
toxicological and eco-toxicological endpoints. Consistent with the TSCA Work Plan Chemical
Scoring methodology, the Hazard Score for each substance was assigned based the highest
hazard score from any individual hazard endpoint, and each substance was ranked as 3 (high),
2 (moderate), or 1 (low) for hazard. The scores for the reproductive toxicity, developmental
toxicity, and chronic toxicity endpoints were based on applying the scoring criteria to the No
Observed Adverse Effect Level (NOAEL) or No Observed Effect Level (NOEL) data rather than
the Lowest Observed Adverse Effect Level (LOAEL) or Lowest Observed Effect Level (LOEL)
data. For hazard endpoints where data from multiple studies were available, the hazard score
was based on the data giving the highest possible score. The only exception to this rule was that
data with a reliability score of 3 (not reliable) were deemed to be unreliable and not used to
determine the hazard score for that particular endpoint.
The raw hazard data for the individual endpoints are summarized in Tables 3-7. No data were
available for any of the benzotriazoles for neurotoxicity or respiratory sensitization and therefore
no scores could be assigned for those hazard categories.
The Hazard Scores for UV-328 and the alternatives are described below and summarized in
Table 2:
• UV-328 was assigned a Hazard Score of 3 (high) based on chronic toxicity (Table 6).
• UV-P was assigned a Hazard Score of 3 (high) based on chronic aquatic toxicity (Table 7).
• UV-234 was assigned a Hazard Score of 2 (medium) based on chronic toxicity (Table 6).
• UV-329 was assigned a Hazard Score of 2 (medium) based on chronic toxicity (Table 6). The
score was deemed to be of low confidence based on the use of structural analog data for the
chronic toxicity endpoint.
• UV-326, UV-360, and UV-928 were assigned Hazard Scores of 1 (low). The Hazard Score
for UV-928 was deemed to be of low confidence based on the use of structural analog data
for some of the hazard endpoints.
Bioaccumulation (B) Scores on a scale of 1 (low) to 3 (high) were assigned using experimental
BCF values from the REACH dossiers. The bioaccumulation data for each substance and the
corresponding B Scores are described below and are summarized in Table 8:
• UV-328 was assigned a Bioaccumulation Score of 3 (high) based on a BCF value of 5,580.
• UV-P was assigned a B Score of 2 (medium) based on a BCF value of 1,623.
• UV-234 was assigned a B Score of 2 (medium) based on a BCF value of 1,286.
• UV-326 was assigned a B Score of 3 (high) based on a BCF value of 7,093.
• UV-329 was assigned a B Score of 1 (low) based on a BCF value of 461.
• UV-360 was assigned a B Score of 1 (low) based on a BCF value of 1.5.
© 2021 James H. Botkin dba BotkinChemie Page 8 of 22
• UV-928 was assigned a B Score of 2 (medium) based on a BCF value of 1,286. The score
was deemed to be of low confidence based on the use of structural analog BCF data.
All of the benzotriazoles were assumed to be very persistent and assigned Persistence (P)
Scores of 3 (high). The B and P Scores were normalized according to the TSCA Work Plan
Chemical Scoring method to give a consolidated Persistence/Bioaccumulation (PB) Score on a
scale of 1 (low) to 3 (high). The normalized PB Scores for each substance are described below
and are summarized in Table 8:
• UV-328, UV-P, UV-234, UV-326, and UV-928 were assigned normalized PB Scores of 3
(high). The PB Score for UV-928 was deemed to be of low confidence based on the use of
structural analog data to assign the B score.
• UV-329 and UV-360 were assigned normalized PB Scores of 2 (medium).
A Total Score for each substance was determined from the sum of PB and T Scores on a
scale of 2 (low) to 6 (high). The Total Scores for each substance are described below and are
summarized in Table 8:
• UV-328 and UV-P were assigned a Total Score of 6 (high).
• UV-234 was assigned a Total Score of 5 (medium-high).
• UV-326, UV-329 and UV-928 were assigned Total Scores of 4 (medium). The Total Scores
for UV-329 and UV-928 were deemed to be of low confidence based on low confidence of the
Hazard Score and/or PB Score.
• UV-360 was assigned a Total Score of 3 (medium-low).
Based on the Total Scores, UV-360 and UV-329 represent the most preferred alternatives to
UV-328. UV-234 is deemed to be less attractive as an alternative based on its higher Total Score,
but can be considered for use in applications where it is technically more suited than UV-360 or
UV-329. UV-928 is potentially useful as an alternative, with the caveat that some of the data used
to assign the Total Score (most notably for bioaccumulation) is of low confidence and should be
confirmed with additional tests.
UV-P is not recommended as an alternative due to its high Total Score (resulting from its high
chronic aquatic toxicity and tendency to bioaccumulate), while UV-326 is deemed to be an
unacceptable alternative because it meets the criteria for a vPvB chemical set out in REACH
Annex XIII, and may be subject to regulation as a SVHC in the future.
Conclusions
The benzotriazole UV absorbers UV-320, UV-327, UV-328, and UV-350 are facing significant
pressures for phase-out due to regulatory developments in Europe. These substances were
added to the Candidate List of Substances of Very High Concern (SVHC) in 2014 and were added
to the REACH Annex XIV List (the “Authorisation List”) in 2020. The basis for regulation is the
identification of these substances as Persistent, Bioaccumulative, and Toxic (PBT) and/or Very
Persistent and Very Bioaccumulative (vPvB) according to the criteria set forth in Annex XIII of the
REACH regulation. The issue is particularly acute for UV-328, which is a high volume product
widely used in plastics and coatings.
Possible alternatives to UV-320, UV-327, UV-328, and UV-350 include UV-P, UV-234, UV-
326, UV-329, UV-360, and UV-928. Of these, only UV-326 (vPvB) meets the criteria for regulation
as PBT or vPvB chemicals set out in REACH Annex XIII based on data currently available in the
REACH dossiers.
© 2021 James H. Botkin dba BotkinChemie Page 9 of 22
Hazard assessments can help additive users to identify chemicals of concern and safer
alternatives. The hazards of the alternatives relative to UV-328 were assessed using a modified
version of the EPA’s TSCA Work Plan Chemical Scoring method. Based on the results of the
hazard assessment, the most attractive alternatives include UV-360, UV-329, and UV-234.
UV-P is not recommended as an alternative due to its high chronic aquatic toxicity and its
tendency to bioaccumulate, which is reflected in its high Total Score. UV-326 is not recommended
as it meets the REACH Annex XIII criteria for a vPvB substance, and as such may be subject to
restriction in the EU in the future.
It should be noted that testing of the benzotriazoles is ongoing, and hazard classifications are
subject to change based on new data. Therefore, it’s essential to keep abreast of new testing
developments and update hazard assessments as necessary.
Hazard assessments are suitable for use to identify other chemicals of concern (such as flame
retardants and plasticizers) and safer alternatives. The GreenScreen List Translator™ is an
excellent starting point for additive users based on its speed and simplicity.
In today’s regulatory environment, assessing hazards is as important as assessing
performance, cost, and commercial availability, and should be a part of the component selection
process for additive users.
Acknowledgements
Helpful advice and comments from Dr. Shari Franjevic of Clean Production Action in the
preparation of the original version of this paper are gratefully acknowledged.
Disclaimer
Although the information and recommendations set forth herein (hereinafter "information") are
presented in good faith and believed to be correct as of the date hereof, BotkinChemie makes no
representation as to the completeness or accuracy thereof. Information is supplied upon the
condition that persons receiving it will make their own determinations as to its suitability for their
purpose prior to its use. In no event will BotkinChemie be responsible for damages of any nature
whatsoever resulting from the use of or reliance upon information. No representations or
warranties either expressed or implied, or merchantability, fitness for a particular purpose or of
any other nature are made hereunder with respect to information for any substance to which
information refers. No statements herein are to be construed as inducements to infringe any valid
patent.
References
1. European Chemicals Agency, “Candidate List of substances of very high concern for
Authorisation”, https://www.echa.europa.eu/candidate-list-table.
2. European Chemicals Agency, “Summary of obligations resulting from inclusion of SVHCS in
the Candidate List”, https://www.echa.europa.eu/candidate-list-obligations.
3. European Chemicals Agency, “Submitted recommendations”,
https://www.echa.europa.eu/previous-recommendations.
3a. European Chemicals Agency, “Estimating the number and types of applications for 11
substances added to the Authorisation List in February 2020”,
https://echa.europa.eu/documents/10162/13634/applications_for_11_substances_Authorisat
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4. European Chemicals Agency, “Public activities coordination tool”,
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02/documents/work_plan_chemicals_web_final.pdf.
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9. U.S. Environmental Protection Agency, “TSCA Work Plan for Chemical Assessments: 2014
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01/documents/tsca_work_plan_chemicals_2014_update-final.pdf.
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10e. Maine Department of Environmental Protection, “Chemicals of concern”,
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ml#list.
11. Environment and Climate Change Canada, Health Canada, “Screening Assessment Report
on Phenol, 2-(2H-benzotriazol-2-yl)-4,6-bis(1,1- dimethylpropyl)- (BDTP) Chemical Abstracts
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change/services/canadian-environmental-protection-act-registry/substances-list.html#toc1.
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of Very High Concern on the Basis of the Criteria Set Out in REACH Article 57; Substance
Name: 2,4-Di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327); EC Number: 223-383-
8; CAS Number: 3864-99-1”, August 3, 2015, pp. 33-42,
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No. 1907/2006 of the European Parliament and of the Council of 18 December 2006
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(REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and
repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No
1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC; https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A02006R1907-20140410.
14. Office of Pollution Protection and Toxics, US Environmental Protection Agency, “Use
Information for Persistent, Bioaccumulative, and Toxic Chemicals under TSCA Section 6(h)”,
webinar, September 7, 2017, https://www.epa.gov/assessing-and-managing-chemicals-
under-tsca/presentation-september-7-2017-webinar-use-information.
© 2021 James H. Botkin dba BotkinChemie Page 12 of 22
15. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-p-cresol,
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/13300.
16. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-4,6-bis(1-
methyl-1-phenylethyl)phenol, https://www.echa.europa.eu/web/guest/registration-dossier/-
/registered-dossier/11135.
17. European Chemicals Agency, Registration Dossier for Bumetrizole,
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/5785.
18. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-4,6-
ditertpentylphenol, https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-
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19. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-
tetramethylbutyl)phenol, https://www.echa.europa.eu/web/guest/registration-dossier/-
/registered-dossier/13220.
20. European Chemicals Agency, Registration Dossier for 2,2'-methylenebis(6-(2H-benzotriazol-
2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol),
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/5321.
21. European Chemicals Agency, Registration Dossier for 2,2'-methylenebis(6-(2H-benzotriazol-
2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol),
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22. European Chemicals Agency, Registration Dossier for 2-(2H-1,2,3-benzotriazol-2-yl)-6-(2-
phenylpropan-2-yl)-4-(2,4,4-trimethylpentan-2-yl)phenol,
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97-106.
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2016, 401-412.
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Alternative Assessments; Hester, R., Harrison, R., Eds.; The Royal Society of Chemistry;
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Chemical Assessment Tool (QCAT), https://ecology.wa.gov/Regulations-Permits/Guidance-
technical-assistance/Preventing-hazardous-waste-pollution/Safer-alternatives/Quick-tool-for-
assessing-chemicals.
31. Clean Production Action, GreenScreen List Translator™,
https://www.greenscreenchemicals.org/learn/greenscreen-list-translator.
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32. Healthy Building Network, Pharos Project, https://www.pharosproject.net.
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34. Botkin, J.; Stone, A.; “GreenScreen® Assessment for Bumetrizole”; December 2016;
https://www.slideshare.net/JimBotkin/greenscreen-assessment-bumetrizole-uv-326-casrn-
3896115.
© 2021 James H. Botkin dba BotkinChemie Page 14 of 22
Table 1. Chemical Identity of Benzotriazole UV Absorbers.
Generic
Name
Chemical Name CAS No. Chemical Structure
UV-P 2-(2H-Benzotriazol-2-yl)-p-cresol 2440-22-4
UV-234 2-(2H-Benzotriazol-2-yl)-4,6-
bis(1-methyl-1-
phenylethyl)phenol
70321-86-7
UV-320 2-Benzotriazol-2-yl-4,6-di-tert-
butylphenol
3846-71-7
UV-326 2-tert-Butyl-4-methyl-6-(5-
chlorobenzotriazol-2-yl)phenol
3896-11-5
UV-327 2,4-Di-tert-butyl-6-(5-
chlorobenzotriazol-2-yl)phenol
3864-99-1
UV-328 2-(2H-Benzotriazol-2-yl)-4,6-di-
tert-pentylphenol
25973-55-1
UV-329 2-(2H-Benzotriazol-2-yl)-4-
(1,1,3,3-tetramethylbutyl)phenol
3147-75-9
UV-350 2-(2H-Benzotriazol-2-yl)-4-(tert-
butyl)-6-(sec-butyl)phenol
36437-37-3
UV-360 2,2'-Methylenebis(6-(2H-
benzotriazol-2-yl)-4-(1,1,3,3-
tetramethylbutyl)phenol)
103597-45-1
UV-928 2-(2H-1,2,3-benzotriazol-2-yl)-6-
(2-phenylpropan-2-yl)-4-(2,4,4-
trimethylpentan-2-yl)phenol
73936-91-1
© 2021 James H. Botkin dba BotkinChemie Page 15 of 22
Table 2. Hazard Scoring Summary for UV-328 and Alternatives.
Acute
Toxicity
Carc. Muta. Repr.
Tox
Dev. Tox Neurotox. Chronic
Toxicity
Resp.
Sens.
Aquatic
Acute
Aquatic
Chronic
Hazard
Score
UV-P 1 1 1 1 1 - 2 - 1 3 3
UV-234 1 - 1 - 1 - 2 - 1 1 2
UV-326 1 1 1 1 1 - 1 - 1 1 1
UV-328 1 - 1 2 1 - 3 - 1 - 3
UV-329 1 - 1 1 1 - 2 - 1 1 2
UV-360 1 - 1 1 1 - 1 - 1 1 1
UV-928 1 - 1 - 1 - 1 - 1 1 1
Notes: Endpoint scores and Hazard Scores given in italics are deemed to be of low confidence.
© 2021 James H. Botkin dba BotkinChemie Page 16 of 22
Table 3. Acute Toxicity Data for UV-328 and Alternatives.
Generic
Name
Oral LD50
Reliability
Score
Inhalation LC50
Reliability
Score
Dermal LD50
Reliability
Score
Hazard
Score
UV-P Rat, 10,000 mg/kg
Mouse, >5,000 mg/kg
Rat, >5,000 mg/kg
Mouse, 6,500 mg/kg
Rat, >15,380 mg/kg
Mouse, >5,500 mg/kg
2
4
4
4
3
4
Rat (4 h), >0.59 mg/L
Rat (1.2 h), >163 mg/L
Rat (4 h), >1.42 mg/L
2
4
4
Rat, >2,000 mg/kg
Unk., >3,038 mg/kg
Rat, >1,000 mg/kg
4
3
2
1
UV-234 Rat, >7,750 mg/kg 2 No data - Rat, >2,000 mg/kg 1 1
UV-326 Rat, >2,000 mg/kg
Rat, >7,750 mg/kg
Mouse, >5,000 mg/kg
Rat, >5,000 mg/kg
Rat, >2,110 mg/kg
1
2
4
4
2
Rat (4 h), >0.27 mg/L 3 Rat, >2,000 mg/kg 2 1
UV-328 Rat, >7,750 mg/kg
Rat, >2,000 mg/kg
Rat, >7,100 mg/kg
Mouse, >5,000 mg/kg
Rat, >5,000 mg/kg
2
2
2
2
2
Rat (4 h), >0.4 mg/L
Rat (1 h) > 0.129 mg/L
2
2
Rabbit, >1,100 mg/kg 2 1
UV-329 Rat, >10,000 mg/kg 2 No data - Rabbit, >5,000 mg/kg 2 1
UV-360 Rat, >2,000 mg/kg
Rat, >5,000 mg/kg
-
2
No data - Rat, >2,000 mg/kg - 1
UV-928 Rat, >2,000 mg/kg
Rat, >2,000 mg/kg
Rat, >5,000 mg/kg
1
1
1
No data - Rat, >2,000 mg/kg
Rat, >2,000 mg/kg
Rabbit, >2,000 mg/kg
1
1
1
1
Notes: The benzotriazole UV absorbers generally present low acute toxicity by the oral and dermal routes, but only limited data are available for the
inhalation route. Data with a reliability score of 3 were deemed to be not reliable and were not used to determine the score. Applying the TSCA
Work Plan Chemical Scoring criteria yields a score of 1 (low) for all seven substances.
© 2021 James H. Botkin dba BotkinChemie Page 17 of 22
Table 4. Carcinogenicity and Mutagenicity/Genotoxicity Data for UV-328 and Alternatives.
Generic
Name
Carcinogenicity Reliability
Score
Hazard
Score
Mutagenicity/Genotoxicity Reliability
Score
Hazard
Score
UV-P Rat, OECD 452, negative
Mouse, OECD 451, negative
1
1
1 OECD 476, negative
OECD 471, negative
in vitro gene mutation in bacteria, negative
in vitro gene mutation in bacteria, negative
in vitro gene mutation in bacteria, negative
1
1
3
3
3
1
UV-234 No data - - OECD 471, negative
OECD 482, negative
OECD 474, negative
EPA OTS 798.5915, negative
2
2
2
2
1
UV-326 Mouse, OECD 451, negative
Rat, OECD 453, negative
2
2
1 OECD 473, negative
OECD 471, negative
OECD 471, negative
OECD 478, negative
OECD 474, negative
OECD 475, negative
1
1
2
2
2
2
1
UV-328 No data - - OECD 471, negative
OECD 473, negative
OECD 476, negative
2
1
1
1
UV-329 No data - - OECD 471, negative
OECD 473, negative
OECD 476, negative
in vitro DNA damage / repair study, negative
2
1
1
4
1
UV-360 No data - - OECD 471, negative
OECD 473, negative
OECD 476, negative
-
-
-
1
UV-928 No data - - OECD 471, negative
OECD 473, negative
OECD 476, negative
OECD 471, negative
1
1
1
1
1
Notes: UV-P and UV-326 are deemed to be negative for carcinogenicity based on the results of 2-year studies in rats and mice. Applying the TSCA Work Plan
Chemical Scoring criteria yields a score of 1 (low) for UV-P and UV-326. For the other substances no score could be assigned due to lack of data. No positive
results for mutagenicity/genotoxicity were obtained for UV-328 or the alternatives. Applying the TSCA Work Plan Chemical Scoring criteria yields a score of 1 (low)
for all seven substances.
© 2021 James H. Botkin dba BotkinChemie Page 18 of 22
Table 5. Reproductive and Developmental Toxicity Data for UV-328 and Alternatives.
Generic
Name
Reproductive Toxicity Reliability
Score
Hazard
Score
Developmental Toxicity Reliability
Score
Hazard
Score
UV-P OECD 422 (rat), NOAEL 300 mg/kg/d 1 1 OECD 414 (rat), NOAEL 1,000 mg/kg/d
OECD 414 (mouse), NOEL 1,000 mg/kg/d
2
1
1
UV-234 Not deemed to be toxic to reproduction
based on a lack of reproductive effects
observed in 28 and 90-day repeated
dose studies (rats), and in an OECD
414 study. However, this may not be
sufficient to assign a score under the
TSCA Work Plan Chemical Scoring
criteria, and no hazard score was
assigned.
- - OECD 414 (rat), NOEL 3,000 mg/kg/d 2 1
UV-326 OECD 422 (rat), NOAEL 1,000 mg/kg/d 1 1 OECD 414 (rat), NOAEL 3,000 mg/kg/d
OECD 414 (mouse), NOAEL 3,000 mg/kg/d
2 1
UV-328 OECD 422 (rat), NOEL 250 mg/kg/d
(read across from structural analog)
2 2 OECD 414 (rat), NOAEL 1,000 mg/kg/d 2 1
UV-329 OECD 422 (rat), NOAEL 300 mg/kg/d
(read across from structural analog)
2 1 OECD 414 (rat), NOAEL 1,000 mg/kg/d
(read across from structural analog)
2 1
UV-360 OECD 415 (rat), NOEL 300 mg/kg/d
Fertility study (rat), NOEL 1,000
mg/kg/d
One generation study (rat), NOEL 1000
mg/kg/d
-
-
-
1 OECD 414 (rat), NOAEL 1,000 mg/kg/d - 1
UV-928 No data - - OECD 414 (rat), NOAEL 3,000 mg/kg/d
(read across from structural analog)
2 1
Notes: No reproductive toxicity data were available for UV-234 and UV-928, and therefore no score was assigned. The scores for the other
substances were obtained by applying the TSCA Work Plan Chemical Scoring criteria to the NOAEL or NOEL values from the studies. UV-328 was
assigned a score of 2 (medium), and the remaining substances (UV-P, UV-326, UV-329, UV-360) were assigned scores of 1 (low). The scores for
UV-328 and UV-329 were deemed to be of low confidence since they are based on structural analog data.
© 2021 James H. Botkin dba BotkinChemie Page 19 of 22
Table 6. Chronic Toxicity Data for UV-328 and Alternatives.
Chronic Toxicity Reliability Score Hazard Score
UV-P OECD 422, rat, 42-53 d, NOAEL = 30 mg/kg/d
OECD 409, dog, 90 d, NOEL = 33 mg/kg/d
OECD 452, rat, 104 wk, NOEL = 1,000 ppm
OECD 408, rat, 90 d, NOEL = 2,000 ppm
OECD 409, dog, 90 d, NOEL = 1000 ppm
No guideline, rat, 6 d/wk for 4 wk, NOEL = 2,500 ppm
1
3
1
2
1
3
2
UV-234 OECD 408, rat, 90 d, NOAEL = 22.3 mg/kg/d
OECD 407, rat, 28 d, NOAEL = 933.8 mg/kg/d
2
2
2
UV-326 OECD 408, rat, 90 d, NOAEL = 637-740 mg/kg/d
OECD 422, rat, 42-53 d, NOAEL = 1000 mg/kg/d
OECD 453, rat, 104 wk, NOEL = 113.2-147.7 mg/kg/d
OECD 409, dog, 90 d, NOAEL = 153-168 mg/kg/d
OECD 407, rat, 28 d, NOAEL = 1,005.7 mg/kg/d
OECD 451, mouse, 104 wk, NOAEL = 59-62 mg/kg/d
No guideline, rat, 28 d, NOAEL = 500 ppm
2
1
2
2
2
2
3
1
UV-328 OECD 408, rat, 90 d, no NOAEL, LOAEL = 10 mg/kg/d
OECD 409, Dog, 90 d, NOAEL = 30 mg/kg/d
2
2
3
UV-329 OECD 422, rat, 42-53 d, NOAEL = 30 mg/kg/d (structural analog)
OECD 452, rat, 104 wk, NOAEL = 142-169 mg/kg/d (structural analog)
No guideline, rat, 28 d, NOAEL = 5,658 mg/kg/d
2
2
3
2
UV-360 OECD 408, rat, 90 d, NOAEL = 1,000 mg/kg/d
OECD 411, rat, 90 d, NOEL = 1,000 mg/kg/d
OECD 407, rat, 28 d, NOEL = 1,000 mg/kg/d
-
-
-
1
UV-928 OECD 408, rat, 90 d, NOEL = 1,000 mg/kg/d
OECD 408, rat, 90 d, NOAEL = 1,000 mg/kg/d
OECD 407, rat, 28 d, NOEL = 1,000 mg/kg/d
1
2
2
1
Notes: The chronic toxicity scores were obtained by applying the TSCA Work Plan Chemical Scoring criteria to the NOAEL or NOEL values from
the studies. Data with a reliability score of 3 were deemed to be not reliable and were not used to determine the score. UV-328 was assigned a
score of 3 (high), UV-P and UV-234 were assigned scores of 2 (medium), and the remaining substances (UV-326, UV-329, UV-360, UV-928) were
assigned scores of 1 (low). The score for UV-329 was deemed to be of low confidence since it was based on structural analog data.
© 2021 James H. Botkin dba BotkinChemie Page 20 of 22
Table 7. Acute and Chronic Aquatic Toxicity Data for UV-328 and Alternatives.
Generic
Name
Acute Aquatic Toxicity Reliability
Score
Hazard
Score
Chronic Aquatic Toxicity Reliability
Score
Hazard
Score
UV-P Fish (96 h), LC50 > 0.17 mg/L
Fish (96 h), LC50 > 100 mg/L
Fish (48 h), LC50 > 200 mg/L
Daphnia (24 h), EC50 > 1,000 mg/L
Algae (72 h), ErC50 > 0.0822 mg/L
1
2
2
2
1
1 Daphnia (21 d), NOEC = 0.013 mg/L 1 3
UV-234 Fish (96 h), LC50 > 67 mg/L
Daphnia (48 h), EC50 > 100 mg/L
Daphnia (24 h), LC50 > 10 mg/L
Daphnia (24 h), EC50 > 91 mg/L
Algae (72 h), EC50 > 100 mg/L
2
1
4
3
2
1 Daphnia (21 d), NOEC ≥ 10 mg/L 1 1
UV-326 Fish (96 h), LC50 > 100 mg/L
Daphnia (48 h), EC50 > 100 mg/L
Daphnia (48 h), LC50 > 10 mg/L
Daphnia (24 h), EC50 > 100 mg/L
Algae (24 h), EC50 > 100 mg/L
2
1
4
3
2
1 Daphnia (21 d), NOEC ≥ 10 mg/L 1 1
UV-328 Fish (96 h), LC50 > 100 mg/L
Fish (96 h), LC50 > 0.078 mg/L
Daphnia (48 h), LC50 > 10 mg/L
Daphnia (24 h), EC50 > 100 mg/L
Daphnia (48 h), EC50 > 0.083 mg/L
Algae (72 h), ErC50 > 0.016 mg/L
Algae (72 h), EC50 > 10 mg/L
2
2
4
4
2
2
2
1 No data - -
UV-329 Fish (96 h), EC50 >100 mg/L
Daphnia (48 h), EC50 > 100 mg/L
Daphnia (48 h), LC50 > 10 mg/L
Daphnia (24 h), EC50 = 15 mg/L
Algae (72 h), EC50 > 100 mg/L
2
1
4
3
2
1 Daphnia (21 d), NOEC ≥ 10 mg/L 1 1
UV-360 Fish (96 h), LC50 > 28.9 mg/L
Fish (96 h), LC50 > 10 mg/L
Fish (96 h), LC50 > 12.7 mg/L
Daphnia (48 h), LC50 > 65.9 mg/L
Daphnia (48 h), EC50 > 50.2 mg/L
-
-
-
-
2
1 Fish (8 wk), NOEC > 1 mg/L
Daphnia (21 d), NOEC > 0.025 mg/L
-
-
1
© 2021 James H. Botkin dba BotkinChemie Page 21 of 22
Daphnia (24 h), LC50 > 100 mg/L
Daphnia (48 h), EC50 > 100 mg/L
Algae (72 h), EC50 > 2 mg/L
Algae (72 h), EC50 > 2 mg/L
-
-
-
2
UV-928 Fish (96 h), LC50 > 0.33 mg/L
Fish (96 h), LC50 > 0.21 mg/L
Daphnia (48 h), EC50 > 0.9 mg/L
Algae (72 h), ErC50 > 0.66 mg/L
Algae (72 h), ErC50 > 0.41 mg/L
1
1
1
1
1
1 Daphnia (21 d), NOEC ≥ 2 mg/L 1 1
Notes: Applying the TSCA Work Plan Chemical Scoring criteria yields an acute aquatic toxicity score of 1 (low) for all seven substances. Data with
a reliability score of 3 were deemed to be not reliable and were not used to determine the score. No chronic aquatic toxicity data were available for
UV-328 and therefore no score was assigned. The chronic toxicity scores for the other substances were obtained by applying the TSCA Work Plan
Chemical Scoring criteria to the NOEC values from the studies. UV-P was assigned a chronic aquatic toxicity hazard score of 3 (high), and the
remaining five substances (UV-234, UV-326, UV-329, UV-360, UV-928) were assigned chronic aquatic toxicity hazard scores of 1 (low).
© 2021 James H. Botkin dba BotkinChemie Page 22 of 22
Table 8. Bioaccumulation Scores, Persistence Scores, Total Scores, and Annex XIII Classifications for UV-328 and Alternatives.
BCF
Reliability
B Score P Score PB Score
Hazard
Score
Total Score Annex XIII Classification
UV-P 1,456-1,623
44-494
1
2
2 3 3 3 6 not PBT, not vPvB
UV-234 415-1,286
5.4-10.4
1
3
2 3 3 2 5 not PBT, not vPvB
UV-326 6,356-7,093
54-895
1
2
3 3 3 1 4 vPvB, not PBT
UV-328 1,120-5,580
570-1,800
2
2
3 3 3 3 6 PBT, vPvB
UV-329 361-461 1 1 3 2 2 4 not PBT, not vPvB
UV-360 0.1-1.5 - 1 3 2 1 3 not PBT, not vPvB
UV-928 415-1,286
361-461
6-27
1
1
2
2 3 3 1 4 not PBT, not vPvB
Notes: The Bioaccumulation (B) scores were obtained by applying the TSCA Work Plan Chemical Scoring criteria to the maximum BCF values
from the REACH dossiers. UV-328 and UV-326 received a B Score of 3 (high); UV-P, UV-234 and UV-928 received B Scores of 2 (medium), and
the remaining substances (UV-329, UV-360) received B Scores of 1 (low). The B Score for UV-928 was deemed to be of low confidence as it was
based on structural analog data and is given in italics.
All of the benzotriazoles were assumed to be highly persistent and assigned Persistence (P) Scores of 3 (high). The B and P Scores were
normalized according to the TSCA Work Plan Chemical Scoring method to PB Scores. UV-P, UV-234, UV-326. UV-328, and UV-928 received PB
Scores of 3 (high), and the remaining substances (UV-329, UV-360) received PB Scores of 2 (medium). The PB Score for UV-928 was deemed
to be of low confidence since the underlying B Score was based on structural analog data, and is given in italics.
The PB and Hazard Scores (from Table 2) were added together to give a Total Score. UV-P and UV-328 received a Total Score of 6 (very high);
UV-234 received a Total Score of 5 (high); UV-326, UV-329 and UV-928 received Total Scores of 4 (medium), and UV-360 received a Total Score
of 3 (medium-low). The Total Scores for UV-329 and UV-928 were deemed to be of low confidence since the underlying B and/or Hazard Scores
were based on structural analog data, and are given in italics.
The benzotriazoles were also rated according to the REACH Annex XIII criteria for PBT and vPvB chemicals. Based on the available data, UV-
328 met the criteria for PBT and vPvB, and UV-326 met the criteria for vPvB.

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Substitution of Benzotriazole UV Absorbers in Plastics: 4/2021 Update

  • 1. © 2021 James H. Botkin dba BotkinChemie Page 1 of 22 Substitution of Benzotriazole UV Absorbers in Plastics: April 2021 Update James H. Botkin dba BotkinChemie, Madison, NH* Original version presented at the SPE Thermoplastic Elastomers Conference, September 2018, Akron, OH Abstract Benzotriazole UV absorbers such as UV-328 have been extensively used as light stabilizers in plastics and coatings for many years. However, increased regulatory compliance burdens associated with designation of some products (including UV-328) as Substances of Very High Concern (SVHC) in Europe are driving additive users around the world to phase-out their use by substitution with safer alternatives. This paper discusses how UV-328 and other benzotriazoles came to be classified as SVHC under REACH, and identifies potentially safer substitutes for additive users based on the results of a hazard assessment. Introduction Benzotriazole UV absorbers are widely used as light stabilizers in plastics and coatings, functioning by competitive absorption of harmful UV radiation. These useful additives feature broad absorbance coverage over both the UV-A (l = 315-400 nm) and UV-B (l = 280-315 nm) regions, minimal absorbance of visible light (l > 400 nm), and excellent long-term photo-stability. Benzotriazoles represent a versatile chemical platform in that products having a wide range of secondary properties (physical form, melting point, volatility) have been developed and are commercially available. However, new regulatory developments in Europe are creating considerable pressure for phase-out or substitution of some products, including the widely used UV-328. This paper seeks to address the following questions associated with the regulation and substitution of benzotriazole UV absorbers: 1. What exactly is happening and what are the implications? 2. What products are affected by regulatory developments? 3. Why are some products being regulated? 4. Will other products be regulated in the future? 5. How can better substitutes be identified? 6. How to formulate in new applications to minimize risks? This updated (4/2021) version of the paper includes a reassessment of the benzotriazole UV absorbers based on new bioaccumulation data and regulatory developments since the original paper was written and presented in 2018. New content is given in red. Affected Products, Status, & Implications The subject products of this paper are ten different commercially available, solid benzotriazole UV absorbers that have been historically been used as light stabilizers in plastics and coatings applications. The common names (based on the Ciba product nomenclature), chemical names, CAS numbers, and chemical structures are provided in Table 1. * E-mail: jim@botkinchemie.com
  • 2. © 2021 James H. Botkin dba BotkinChemie Page 2 of 22 In 2014-2015, four of these substances (UV-320, UV-327, UV-328, and UV-350) were placed on the Candidate List of Substances of Very High Concern (SVHC) by the European Chemicals Agency (ECHA).[1] The basis for this development was the identification of these substances as Persistent, Bioaccumulative, and Toxic (PBT) and/or very Persistent and very Bioaccumulative (vPvB). Under the REACH regulation, there is a duty to communicate information on these substances and other SVHC present above a cut-off concentration (0.1% by weight) in articles, preparations, and chemical products.[2] Producers and importers of articles containing SVHC may also need to submit a notification to ECHA. The increased regulatory burden associated with the designation of these substances as SVHC has pressured additive users to begin phasing out their use by substitution with functionally equivalent alternatives. In February 2018, ECHA recommended addition of UV-320, UV-327, UV-328, and UV-350 to the REACH Annex XIV List (“Authorisation List”),[3] and these substances were formally listed in February 2020.[3a] This represents a more serious regulatory development. Once added to the Authorisation List, companies wanting to continue using these substances are required to apply for authorization with ECHA no later than May 27, 2022 in order to continue existing uses. These substances are also subject to a sunset date of November 27, 2023, after which they cannot be used without authorization. This development has placed additional pressure on additive users worldwide to phase-out the use of these products. The issue is particularly acute for UV-328, which is a high volume product widely used in the plastics and coatings industries. Other benzotriazole UV absorbers (including UV-P, UV-234, UV-326, UV-329, and UV-928) are also under scrutiny by ECHA as part of the REACH regulation. Specific activities include evaluation of REACH registration dossiers, substance evaluation in the Community Rolling Action Plan (CoRAP), assessment of PBT properties, and Regulatory Management Option Analysis (RMOA). The activities are summarized in the Public Activities Coordination Tool (PACT).[4,4a,4b,4c,4d,4e] ECHA cautions that these activities only mean that a Member State or ECHA is examining a substance, not that it actually has PBT properties or that there is need for regulatory risk management actions.[5] For any substance being assessed, the outcome may well be that it is not found to have PBT properties based on available data. However, the fact that these potential alternative products are being scrutinized makes it more difficult for additive formulators to identify appropriate alternatives to UV-328. As part of the review of REACH registration dossiers, new bioaccumulation tests were ordered for UV-P, UV-234, UV-326, and UV-329.[4a,4b,4c,4d]. The new test results for UV-234 and UV- 329 were included in the original version of this paper. The new results for UV-P and UV-326 were published in 2020 and are included in this updated version. The results for UV-326 are particularly noteworthy as they demonstrate a very high tendency to bioaccumulation (vB).[17] UV-P was evaluated by the Czech Republic under CoRAP in 2016 with the conclusion that there was no need for regulatory follow up action at the EU level.[4a] However, this evaluation did not consider its PBT/vPvB properties. PBT property assessments and RMOA have been initiated by EU member states for UV-P, UV-234, UV-326, UV-329, and UV-928.[4a,4b,4c,4d,4e] As of April 2021, none have been completed. In Japan, UV-320 came under regulation as a Class I Specified Chemical Substance in 2007 under the Chemical Substances Control Law (CSCL).[6] Class I Specified Substances are regulated based on being found to be persistent, highly bioaccumulative and posing a risk of long- term toxicity to humans or animals. Under the CSCL, prior permission is required for manufacture and/or import, which constitutes a virtual prohibition except for uses designated as essential. UV-
  • 3. © 2021 James H. Botkin dba BotkinChemie Page 3 of 22 327 and UV-350 are regulated under the CSCL as Monitoring Chemical Substances based on concerns regarding persistence and bioaccumulation.[7] For these substances, annual reporting is required if volumes of manufacturing or import are greater than 1 ton per year. The authority may also order manufacturers and importers to investigate long-term toxicity for humans or animals. None of the other benzotriazole UV absorbers listed in Table 1, including UV-328, are subject to restrictions in Japan under CSCL. In the USA, none of the benzotriazole UV absorbers listed in Table 1 have been subject to hazard assessments by the EPA under the Toxic Substances Control Act (TSCA) Work Plan [8- 9], risk evaluations under amended TSCA,[10,10a], or TSCA section 6(h) rules related to persistent, bioaccumulative, and toxic (PBT) chemicals.[10b] According to information in the EPA Substance Registry,[10c] all of the benzotriazole UV absorbers listed in Table 1 are listed on the TSCA inventory as Active Substances, and none are subject to special requirements under TSCA (including consent orders, significant new use rules, test rules, and export notification requirements). UV-234, UV-320, UV-328, and UV-329 have been listed as chemicals of concern at the State level (CA, ME, MN) but are not currently subject to regulation.[10d,10e,10f] In Canada, a screening assessment was completed by Environment and Climate Change Canada and Health Canada for UV-328 in 2016 with no further action recommended.[11] Several other substances listed in Table 1 (UV-234, UV-326, UV-329, and UV-350) met the criteria for screening under the Canadian Environmental Protection Act (CEPA) and may possibly be subject to screening assessments in the future. None of the benzotriazole UV absorbers listed in Table 1 are subject to special regulation under CEPA, for example by listing on the export control list, the priority substances list, list of toxic substances, the virtual elimination list, or the non-statutory list.[11a] While no regulatory actions on UV-328 are pending in the USA, Japan, or Canada, the importance of Europe in global supply chains continues to provide incentive to additive formulators around the world to replace it with safer alternatives. As part of the search for alternatives, it’s helpful to understand the reasons behind the regulatory issues associated with UV-328, UV-327, UV-320, and UV-350. Rationale for Regulation: Persistence, Bioaccumulation, & Toxicity As described in the previous section, benzotriazoles are subject to regulatory scrutiny based on concerns over their persistence, bioaccumulation, and toxicity. Chemicals known to be persistent, bioaccumulative, and toxic (PBT); or very persistent and very bioaccumulative (vPvB) are of particular concern for regulators since they can remain in the environment for a long time and can bioaccumulate in animal tissues. Over time, releases of these chemicals have the potential to accumulate to higher levels and may cause significant adverse impacts on human health and/or the environment. Persistence is defined as resistance of a chemical substance to environmental degradation through natural chemical, biological, and photolytic processes. This can be inferred through monitoring studies in water, soils, and sediments. Benzotriazoles were first recognized as persistent based on monitoring studies conducted on sediments from locations near a former production site for UV-327 and UV-328 in Rhode Island.[12] Regulators often assess the persistence of a chemical substance by its degradation half-life times (T1/2) in water, sediment, and soil, which can be determined by laboratory tests or the use of molecular modeling software. The criteria for designation of substances as persistent (P) and very persistent (vP) are set forth
  • 4. © 2021 James H. Botkin dba BotkinChemie Page 4 of 22 in Annex XIII of the REACH regulation.[13] In general, chemicals meet the criteria for vP under REACH if their T1/2 in water is greater than 60 days and/or greater than 180 days in soil or sediment. In the USA, the EPA has adopted similar criteria, and a chemical is characterized as vP if its T1/2 in water, soil, or sediment is greater than 6 months.[14] Based on information contained in the REACH dossiers [15-22] and the Candidate List documentation [1] all of the benzotriazole UV absorbers listed in Table 1 are considered to meet the criteria for vP under the REACH criteria, and would probably be characterized as vP under the EPA criteria as well. Bioaccumulation is defined as the tendency of a chemical substance to accumulate in living organisms. This can be inferred through monitoring studies in wildlife or in humans. Benzotriazole UV absorbers were first detected in monitoring studies conducted with marine organisms in Japan,[23] and benzotriazole UV absorbers have since been found in monitoring studies conducted with marine life in other parts of the world.[24-27] Regulators usually assess then tendency of a substance to bioaccumulate using Bioconcentration Factor (BCF) or Bioaccumulation Factor (BAF) values, which are determined by laboratory tests or through the use of molecular modeling software. The criteria for designation of substances as Bioaccumulative (B) and Very Bioaccumulative (vB) are set forth in Annex XIII of the REACH regulation.[13] In general, substances having a BCF value greater than 2,000 are considered to be B, and those having a BCF value greater than 5,000 are considered to be vB. In the USA, the EPA considers a substance to be B if its BCF or BAF value is greater than or equal to 1,000, and vB if its BCF or BAF value is greater than or equal to 5,000. Based on BCF data contained in the REACH dossiers [17,18] and candidate list documentation [1], UV-320, UV-326, UV-327, UV-328, and UV-350 all meet the REACH and EPA criteria for vB. Additionally, the BCF values for UV-P [15], UV-234 [16] and UV-928 [22] meet the EPA criterion for B (although they do not meet the REACH criterion for B). The remaining substances (UV-329 and UV-360) are not considered to be B under either REACH or EPA criteria based on BCF values less than 1,000.[19-21] Toxicity is defined as the degree to which a substance can damage an organism. Toxicity and eco-toxicity are assessed using test methods based on the UN Globally Harmonized System (GHS) of hazard classification. The criteria for designation of a substance as toxic (T) are set forth in Annex XIII of the REACH regulation. Benzotriazoles present varying degrees of chronic toxicity and chronic aquatic toxicity. Based on data contained in the REACH dossier [18] and candidate list documentation [1], UV-320 and UV-328 are considered T under REACH criteria. The remaining substances (UV-P, UV-234, UV-326, UV-327, UV-329, UV-350, UV-360, and UV- 928) do not meet the REACH criteria for T based on candidate list documentation [1] or the REACH dossiers.[15,17,19-21] As defined under the REACH regulation, UV-320, UV-327, UV-328, and UV-350 are all considered to be PBT and/or vPvB substances, and this can be regarded as the root cause for placing them on the Authorisation List. UV-326 can be considered to be a vPvB substance based on available data, and as such may be subject to future listing on the Candidate List of SVHC in the EU. The remaining products (UV-P, UV-234, UV-329, UV-360, UV-928) do not meet the criteria for either PBT or vPvB based on available data, but all can be regarded as being very Persistent (vP) and presenting varying degrees of bioaccumulation and toxicity. However, as the criteria for bioaccumulation and toxicity used by regulators may be subject to change, additive formulators may desire to lower the risk of making a regrettable substitution by selecting
  • 5. © 2021 James H. Botkin dba BotkinChemie Page 5 of 22 alternatives based on their bioaccumulation and toxicity characteristics, for example through a hazard assessment. Identifying Safer Alternatives Using Hazard Assessments Hazard assessments represent part of a larger alternatives assessment process, which addresses other factors such as technical performance, cost, commercial availability, and environmental life cycle attributes. Through the use of hazard assessments, users of chemicals can select safer alternatives and avoid replacing one hazardous substance with another. In the case of the benzotriazole UV absorbers, a hazard assessment is intended to support informed decision-making by additive formulators and end users by providing a basis to rank the attractiveness of alternatives based on their inherent hazard characteristics. Some hazard assessment methods utilize numerical ratings or benchmarks in order to facilitate comparisons between different alternatives. The best methods are based on criteria developed by or consistent with those used by regulatory agencies for evaluating chemical hazards, for example the UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and the EPA Design for the Environment Program Alternatives Assessment Criteria for Hazard Evaluation (DfE). Numerous hazard assessment methods have been developed. Examples include: • GreenScreen® for Safer Chemicals (“GreenScreen®)• • GreenScreen List Translator™ • Quick Chemical Assessment Tool (QCAT) • EPA TSCA Work Plan Chemical Scoring GreenScreen® is a hazard assessment method developed by the NGO Clean Production Action, that is designed for use by businesses, government agencies, and certification bodies to identify chemicals of high concern and safer alternatives.[28-29] This comprehensive method expands on the GHS and DfE methods, with a full GreenScreen® assessment covering human health and environmental effects data for a chemical substance based on 18 different hazard endpoints (carcinogenicity, mutagenicity/genotoxicity, reproductive toxicity, developmental toxicity, endocrine activity, acute human toxicity, respiratory sensitization, skin irritation/corrosivity, eye irritation/corrosivity, acute aquatic toxicity, chronic aquatic toxicity, neurotoxicity, systemic toxicity/organ effects, skin sensitization, persistence, bioaccumulation, physical reactivity, and flammability). Based on the results of the assessment, chemical substances are assigned one of five benchmark scores: Benchmark-1 (avoid – chemical of high concern), Benchmark-2 (use but search for safer substitutes), Benchmark-3 (use but still opportunity for improvement), Benchmark-4 (prefer – safer chemical), or Benchmark U (not classifiable due to lack of data). The benchmark scoring makes the comparison of the hazards associated with different alternatives a straightforward exercise. Use of the GreenScreen® method would provide the most authoritative differentiation between the benzotriazole UV absorbers under consideration. However, due to its comprehensive nature, GreenScreen® assessments are inherently time consuming, and specialized training is recommended for personnel prior to conducting assessments. For this reason, simpler methods may be appropriate for a preliminary screening. The QCAT is a simplified hazard assessment method developed by the Washington State Department of Ecology with the support of Clean Production Action.[30] This method utilizes a • GreenScreen® and GreenScreen List Translator™ are trademarks of Clean Production Action.
  • 6. © 2021 James H. Botkin dba BotkinChemie Page 6 of 22 smaller number of hazard endpoints (carcinogenicity, mutagenicity/genotoxicity, reproductive toxicity, developmental toxicity, endocrine activity, acute mammalian toxicity, acute aquatic toxicity, persistence, and bioaccumulation) and data sources than GreenScreen® to reduce the number data sources and time required to complete an assessment. Based on the results of the assessment, chemical substances are assigned one of four grades: A (high concern, avoid), B (moderate concern, use but search for safer alternatives), C (slight concern, improvement possible), or D (few concerns, preferable). This method is recommended for use to screen chemicals to determine whether a more in-depth assessment such as GreenScreen® is necessary. In the case of the benzotriazole UV absorbers, the downside of this method is that it does not cover known hazards such as chronic toxicity and chronic aquatic toxicity. The GreenScreen List Translator™ screening tool developed for the rapid identification of chemicals of high concern.[31] The method scores chemical substances based on information from hazard lists developed by authoritative scientific bodies around the world. The results are used to assign one of three List Translator scores: LT-1 (indicating the presence of a chemical on at least one authoritative hazard list expected to result in a Benchmark-1 score if further assessed with GreenScreen®), LT-P1 (indicating presence of a chemical on at least one hazard list that may possibly result in a Benchmark-1 score upon further assessment with GreenScreen®), or LT-UNK (indicating that the chemical is present on one or more lists but does not meet any of the criteria to assign an LT-1 or LT-P1 score). If no information is found for a chemical in any of the hazard lists, the substance is assigned a score of “NoGSLT”. GreenScreen List Translator™ scores can be determined easily and quickly using online services such as the Pharos Chemical and Material Library from the Healthy Building Network NGO.[32] While the method is suitable for the identification of chemicals of high concern, more comprehensive methods such as GreenScreen® are more appropriate for use in the identification of safer alternatives. The TSCA Work Plan Chemical Scoring method is used by the EPA to identify potential candidate chemicals for assessment under TSCA.[33] Chemicals are evaluated and given a score based on three characteristics: Hazard, Exposure, and potential for Persistence and Bioaccumulation. The Hazard and Persistence/Bioaccumulation Scores are derived from the EPA DfE criteria based on 12 different endpoints (acute toxicity, carcinogenicity, mutagenicity/ genotoxicity, reproductive toxicity, developmental toxicity, neurotoxicity, chronic toxicity, respiratory sensitization, acute aquatic toxicity, chronic aquatic toxicity). While this screening process is intended mainly to support initial decisions by the EPA to determine the relative priority of chemicals for further assessments, the Hazard and Persistence/Bioaccumulation Scores are suitable for use as the basis for a simplified hazard assessment to identify chemicals of concern and make a preliminary screening of alternatives. Note that the Exposure Score relates to risks rather than the inherent hazards of a chemical substance, and therefore is not appropriate for inclusion in a hazard assessment. Please note that the quality and reliability of any hazard assessment is a function of the data on which it is based, and is also subject to change as new data is generated. In the author’s own experience, a GreenScreen® assessment of bumetrizole (UV-326) was prepared in 2015, which resulted in a benchmark score of Benchmark-2 (use but search for safer substitutes).[34] As part of the dossier evaluation process under REACH, ECHA proposed new bioaccumulation tests for the substance in 2019,[4c] which were completed and added to the dossier in 2020.[17] The new data indicated that the substance has a very high tendency to bioaccumulate (BCF = 6,356– 7,093), and applying this data in the GreenScreen® assessment results in a benchmark score of Benchmark-1 (avoid – chemical of high concern). The key learning here is the importance of keeping assessments up to date by monitoring new testing developments, particularly for
  • 7. © 2021 James H. Botkin dba BotkinChemie Page 7 of 22 substances for which new testing is pending under REACH (testing proposals) or TSCA (test orders). Hazard Assessment Screening of Benzotriazole UV Absorbers A modified version of the EPA’s TSCA Work Plan Chemical Scoring method was used to make a preliminary assessment of six different benzotriazole UV absorbers (UV-P, UV-234, UV- 326, UV-329, UV-360, and UV-928) as alternatives to UV-328. The method criteria [33] were applied using data and interpretations from the EU REACH dossiers [15-22] to obtain the Hazard and Persistence/Bioaccumulation scores. The alternatives were ranked based on the Total Score, which was defined as the sum of the Hazard and Persistence/Bioaccumulation Scores. Hazard Scores were assigned for UV-328 and the alternatives based on 10 different toxicological and eco-toxicological endpoints. Consistent with the TSCA Work Plan Chemical Scoring methodology, the Hazard Score for each substance was assigned based the highest hazard score from any individual hazard endpoint, and each substance was ranked as 3 (high), 2 (moderate), or 1 (low) for hazard. The scores for the reproductive toxicity, developmental toxicity, and chronic toxicity endpoints were based on applying the scoring criteria to the No Observed Adverse Effect Level (NOAEL) or No Observed Effect Level (NOEL) data rather than the Lowest Observed Adverse Effect Level (LOAEL) or Lowest Observed Effect Level (LOEL) data. For hazard endpoints where data from multiple studies were available, the hazard score was based on the data giving the highest possible score. The only exception to this rule was that data with a reliability score of 3 (not reliable) were deemed to be unreliable and not used to determine the hazard score for that particular endpoint. The raw hazard data for the individual endpoints are summarized in Tables 3-7. No data were available for any of the benzotriazoles for neurotoxicity or respiratory sensitization and therefore no scores could be assigned for those hazard categories. The Hazard Scores for UV-328 and the alternatives are described below and summarized in Table 2: • UV-328 was assigned a Hazard Score of 3 (high) based on chronic toxicity (Table 6). • UV-P was assigned a Hazard Score of 3 (high) based on chronic aquatic toxicity (Table 7). • UV-234 was assigned a Hazard Score of 2 (medium) based on chronic toxicity (Table 6). • UV-329 was assigned a Hazard Score of 2 (medium) based on chronic toxicity (Table 6). The score was deemed to be of low confidence based on the use of structural analog data for the chronic toxicity endpoint. • UV-326, UV-360, and UV-928 were assigned Hazard Scores of 1 (low). The Hazard Score for UV-928 was deemed to be of low confidence based on the use of structural analog data for some of the hazard endpoints. Bioaccumulation (B) Scores on a scale of 1 (low) to 3 (high) were assigned using experimental BCF values from the REACH dossiers. The bioaccumulation data for each substance and the corresponding B Scores are described below and are summarized in Table 8: • UV-328 was assigned a Bioaccumulation Score of 3 (high) based on a BCF value of 5,580. • UV-P was assigned a B Score of 2 (medium) based on a BCF value of 1,623. • UV-234 was assigned a B Score of 2 (medium) based on a BCF value of 1,286. • UV-326 was assigned a B Score of 3 (high) based on a BCF value of 7,093. • UV-329 was assigned a B Score of 1 (low) based on a BCF value of 461. • UV-360 was assigned a B Score of 1 (low) based on a BCF value of 1.5.
  • 8. © 2021 James H. Botkin dba BotkinChemie Page 8 of 22 • UV-928 was assigned a B Score of 2 (medium) based on a BCF value of 1,286. The score was deemed to be of low confidence based on the use of structural analog BCF data. All of the benzotriazoles were assumed to be very persistent and assigned Persistence (P) Scores of 3 (high). The B and P Scores were normalized according to the TSCA Work Plan Chemical Scoring method to give a consolidated Persistence/Bioaccumulation (PB) Score on a scale of 1 (low) to 3 (high). The normalized PB Scores for each substance are described below and are summarized in Table 8: • UV-328, UV-P, UV-234, UV-326, and UV-928 were assigned normalized PB Scores of 3 (high). The PB Score for UV-928 was deemed to be of low confidence based on the use of structural analog data to assign the B score. • UV-329 and UV-360 were assigned normalized PB Scores of 2 (medium). A Total Score for each substance was determined from the sum of PB and T Scores on a scale of 2 (low) to 6 (high). The Total Scores for each substance are described below and are summarized in Table 8: • UV-328 and UV-P were assigned a Total Score of 6 (high). • UV-234 was assigned a Total Score of 5 (medium-high). • UV-326, UV-329 and UV-928 were assigned Total Scores of 4 (medium). The Total Scores for UV-329 and UV-928 were deemed to be of low confidence based on low confidence of the Hazard Score and/or PB Score. • UV-360 was assigned a Total Score of 3 (medium-low). Based on the Total Scores, UV-360 and UV-329 represent the most preferred alternatives to UV-328. UV-234 is deemed to be less attractive as an alternative based on its higher Total Score, but can be considered for use in applications where it is technically more suited than UV-360 or UV-329. UV-928 is potentially useful as an alternative, with the caveat that some of the data used to assign the Total Score (most notably for bioaccumulation) is of low confidence and should be confirmed with additional tests. UV-P is not recommended as an alternative due to its high Total Score (resulting from its high chronic aquatic toxicity and tendency to bioaccumulate), while UV-326 is deemed to be an unacceptable alternative because it meets the criteria for a vPvB chemical set out in REACH Annex XIII, and may be subject to regulation as a SVHC in the future. Conclusions The benzotriazole UV absorbers UV-320, UV-327, UV-328, and UV-350 are facing significant pressures for phase-out due to regulatory developments in Europe. These substances were added to the Candidate List of Substances of Very High Concern (SVHC) in 2014 and were added to the REACH Annex XIV List (the “Authorisation List”) in 2020. The basis for regulation is the identification of these substances as Persistent, Bioaccumulative, and Toxic (PBT) and/or Very Persistent and Very Bioaccumulative (vPvB) according to the criteria set forth in Annex XIII of the REACH regulation. The issue is particularly acute for UV-328, which is a high volume product widely used in plastics and coatings. Possible alternatives to UV-320, UV-327, UV-328, and UV-350 include UV-P, UV-234, UV- 326, UV-329, UV-360, and UV-928. Of these, only UV-326 (vPvB) meets the criteria for regulation as PBT or vPvB chemicals set out in REACH Annex XIII based on data currently available in the REACH dossiers.
  • 9. © 2021 James H. Botkin dba BotkinChemie Page 9 of 22 Hazard assessments can help additive users to identify chemicals of concern and safer alternatives. The hazards of the alternatives relative to UV-328 were assessed using a modified version of the EPA’s TSCA Work Plan Chemical Scoring method. Based on the results of the hazard assessment, the most attractive alternatives include UV-360, UV-329, and UV-234. UV-P is not recommended as an alternative due to its high chronic aquatic toxicity and its tendency to bioaccumulate, which is reflected in its high Total Score. UV-326 is not recommended as it meets the REACH Annex XIII criteria for a vPvB substance, and as such may be subject to restriction in the EU in the future. It should be noted that testing of the benzotriazoles is ongoing, and hazard classifications are subject to change based on new data. Therefore, it’s essential to keep abreast of new testing developments and update hazard assessments as necessary. Hazard assessments are suitable for use to identify other chemicals of concern (such as flame retardants and plasticizers) and safer alternatives. The GreenScreen List Translator™ is an excellent starting point for additive users based on its speed and simplicity. In today’s regulatory environment, assessing hazards is as important as assessing performance, cost, and commercial availability, and should be a part of the component selection process for additive users. Acknowledgements Helpful advice and comments from Dr. Shari Franjevic of Clean Production Action in the preparation of the original version of this paper are gratefully acknowledged. Disclaimer Although the information and recommendations set forth herein (hereinafter "information") are presented in good faith and believed to be correct as of the date hereof, BotkinChemie makes no representation as to the completeness or accuracy thereof. Information is supplied upon the condition that persons receiving it will make their own determinations as to its suitability for their purpose prior to its use. In no event will BotkinChemie be responsible for damages of any nature whatsoever resulting from the use of or reliance upon information. No representations or warranties either expressed or implied, or merchantability, fitness for a particular purpose or of any other nature are made hereunder with respect to information for any substance to which information refers. No statements herein are to be construed as inducements to infringe any valid patent. References 1. European Chemicals Agency, “Candidate List of substances of very high concern for Authorisation”, https://www.echa.europa.eu/candidate-list-table. 2. European Chemicals Agency, “Summary of obligations resulting from inclusion of SVHCS in the Candidate List”, https://www.echa.europa.eu/candidate-list-obligations. 3. European Chemicals Agency, “Submitted recommendations”, https://www.echa.europa.eu/previous-recommendations. 3a. European Chemicals Agency, “Estimating the number and types of applications for 11 substances added to the Authorisation List in February 2020”, https://echa.europa.eu/documents/10162/13634/applications_for_11_substances_Authorisat ion_List_February_2020.pdf/66fd8424-5f57-9c33-f3e5-265f01f754ba.
  • 10. © 2021 James H. Botkin dba BotkinChemie Page 10 of 22 4. European Chemicals Agency, “Public activities coordination tool”, https://www.echa.europa.eu/pact. 4a. European Chemicals Agency, “Public activities coordination tool. 2-(2H-benzotriazol-2-yl) p-cresol”, https://www.echa.europa.eu/web/guest/pact?p_p_id=disspact_WAR_disspactportlet&p_p_lif ecycle=0&_disspact_WAR_disspactportlet_substanceId=100.017.700&_disspact_WAR_dis spactportlet_jspPage=%2Fhtml%2Fportlet%2Fdisspact%2FdetailsPage%2Fview_detailsPa ge.jsp. 4b. European Chemicals Agency, “Public activities coordination tool. 2-(2H-benzotriazol-2-yl) 4,6-bis(1-methyl-1-phenylethyl)phenol”, https://www.echa.europa.eu/web/guest/pact?p_p_id=disspact_WAR_disspactportlet&p_p_lif ecycle=0&_disspact_WAR_disspactportlet_substanceId=100.067.769&_disspact_WAR_dis spactportlet_jspPage=%2Fhtml%2Fportlet%2Fdisspact%2FdetailsPage%2Fview_detailsPa ge.jsp. 4c. European Chemicals Agency, “Public activities coordination tool. Bumetrizole”, https://www.echa.europa.eu/web/guest/pact?p_p_id=disspact_WAR_disspactportlet&p_p_lif ecycle=0&_disspact_WAR_disspactportlet_substanceId=100.021.315&_disspact_WAR_dis spactportlet_jspPage=%2Fhtml%2Fportlet%2Fdisspact%2FdetailsPage%2Fview_detailsPa ge.jsp. 4d. European Chemicals Agency, “Public activities coordination tool. 2-(2H-benzotriazol-2-yl)- 4-(1,1,3,3-tetramethylbutyl)phenol”, https://www.echa.europa.eu/web/guest/pact?p_p_id=disspact_WAR_disspactportlet&p_p_lif ecycle=0&_disspact_WAR_disspactportlet_substanceId=100.019.612&_disspact_WAR_dis spactportlet_jspPage=%2Fhtml%2Fportlet%2Fdisspact%2FdetailsPage%2Fview_detailsPa ge.jsp. 4e. European Chemicals Agency, “Public activities coordination tool. 2-(2H-1,2,3-benzotriazol- 2-yl)-6-(2-phenylpropan-2-yl)-4-(2,4,4-trimethylpentan-2-yl)phenol”, https://www.echa.europa.eu/web/guest/pact?p_p_id=disspact_WAR_disspactportlet&p_p_lif ecycle=0&_disspact_WAR_disspactportlet_substanceId=100.102.117&_disspact_WAR_dis spactportlet_jspPage=%2Fhtml%2Fportlet%2Fdisspact%2FdetailsPage%2Fview_detailsPa ge.jsp. 5. European Chemicals Agency, “Understanding PACT”, https://www.echa.europa.eu/understanding-pact. 6. National Institute of Technology and Evaluation, “Japan CSCL: Class I Specified Chemical Substances”, https://www.nite.go.jp/en/chem/chrip/chrip_search/intSrhSpcLst?_e_trans=&slScNm=RJ_01 _001. 7. National Institute of Technology and Evaluation, “Japan CSCL: Monitoring Chemical Substances”, https://www.nite.go.jp/en/chem/chrip/chrip_search/intSrhSpcLst?_e_trans=&slScNm=RJ_01 _010. 8. U.S. Environmental Protection Agency, “TSCA Work Plan Chemicals”, June 2012, https://www.epa.gov/sites/production/files/2014- 02/documents/work_plan_chemicals_web_final.pdf.
  • 11. © 2021 James H. Botkin dba BotkinChemie Page 11 of 22 9. U.S. Environmental Protection Agency, “TSCA Work Plan for Chemical Assessments: 2014 Update”, October 2014, https://www.epa.gov/sites/production/files/2015- 01/documents/tsca_work_plan_chemicals_2014_update-final.pdf. 10. Federal Register of July 7, 2017, pp. 31592-31593, Docket ID EPA-HQ-OPPT-2017-0327, https://www.regulations.gov/document?D=EPA-HQ-OPPT-2017-0327-0001. 10a. U.S. Environmental Protection Agency, “Chemicals Undergoing Risk Evaluation under TSCA”, October 2020, https://www.epa.gov/assessing-and-managing-chemicals-under- tsca/chemicals-undergoing-risk-evaluation-under-tsca. 10b. U.S. Environmental Protection Agency, “Persistent, Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h)”, January 2021, https://www.epa.gov/assessing-and- managing-chemicals-under-tsca/persistent-bioaccumulative-and-toxic-pbt-chemicals-under. 10c. U.S. Environmental Protection Agency, “Substance registry services”, https://sor.epa.gov/sor_internet/registry/substreg/LandingPage.do. 10d. California Department of Toxic Substances Control, “Candidate chemicals list”, https://dtsc.ca.gov/scp/candidate-chemicals-list/. 10e. Maine Department of Environmental Protection, “Chemicals of concern”, https://www.maine.gov/dep/safechem/childrens-products/concern/index.html. 10f. Minnesota Department of Public Health, “Chemicals of high concern”, https://www.health.state.mn.us/communities/environment/childenvhealth/tfka/highconcern.ht ml#list. 11. Environment and Climate Change Canada, Health Canada, “Screening Assessment Report on Phenol, 2-(2H-benzotriazol-2-yl)-4,6-bis(1,1- dimethylpropyl)- (BDTP) Chemical Abstracts Service Registry Number 25973-55-1”, May 2016, http://publications.gc.ca/collections/collection_2016/eccc/En14-236-2015-eng.pdf. 11a. Environment and Climate Change Canada, “Lists of substances: Canadian Environmental Protection Act, 1999”, June 7, 2018, https://www.canada.ca/en/environment-climate- change/services/canadian-environmental-protection-act-registry/substances-list.html#toc1. 12. European Chemicals Agency, “Annex XV report; Proposal for Identification of a Substance of Very High Concern on the Basis of the Criteria Set Out in REACH Article 57; Substance Name: 2,4-Di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327); EC Number: 223-383- 8; CAS Number: 3864-99-1”, August 3, 2015, pp. 33-42, https://www.echa.europa.eu/documents/10162/755b24e4-40dc-455b-afc0-b5e4e9045701. 13. Annex XIII: Criteria for the Identification of Persistent, Bioaccumulative, and Toxic Substances, and Very Persistent and Very Bioaccumulative Substances; Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC; https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A02006R1907-20140410. 14. Office of Pollution Protection and Toxics, US Environmental Protection Agency, “Use Information for Persistent, Bioaccumulative, and Toxic Chemicals under TSCA Section 6(h)”, webinar, September 7, 2017, https://www.epa.gov/assessing-and-managing-chemicals- under-tsca/presentation-september-7-2017-webinar-use-information.
  • 12. © 2021 James H. Botkin dba BotkinChemie Page 12 of 22 15. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-p-cresol, https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/13300. 16. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-4,6-bis(1- methyl-1-phenylethyl)phenol, https://www.echa.europa.eu/web/guest/registration-dossier/- /registered-dossier/11135. 17. European Chemicals Agency, Registration Dossier for Bumetrizole, https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/5785. 18. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-4,6- ditertpentylphenol, https://www.echa.europa.eu/web/guest/registration-dossier/-/registered- dossier/5280. 19. European Chemicals Agency, Registration Dossier for 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3- tetramethylbutyl)phenol, https://www.echa.europa.eu/web/guest/registration-dossier/- /registered-dossier/13220. 20. European Chemicals Agency, Registration Dossier for 2,2'-methylenebis(6-(2H-benzotriazol- 2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol), https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/5321. 21. European Chemicals Agency, Registration Dossier for 2,2'-methylenebis(6-(2H-benzotriazol- 2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol), https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/13964. 22. European Chemicals Agency, Registration Dossier for 2-(2H-1,2,3-benzotriazol-2-yl)-6-(2- phenylpropan-2-yl)-4-(2,4,4-trimethylpentan-2-yl)phenol, https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-dossier/15623. 23. Nakata, H.; Murata, S.; Filatreau, J.; Environmental Science and Technology, 43, 2009, 6920-6926. 24. Kim, J.-W.; Isobe, T.; Ramaswamy, B.; Chang, K.-H.; Amano, A.; Miller, T.; Siringan, F.; and Tanabe, S.; Chemosphere, 85, 2011, 751-758. 25. Nakata, H.; Shinohara, R-I.; Nakazawa, Y.; Isobe, T.; Sudaryanto, A.; Subramanian, A.; Tanabe, S.; Zakaria, M.; Zheng, G.; Lam, P.; Kim, E.; Min, B.-Y.; We, S.-U.; Viet, P.; Tana, T.; Prudente, M.; Donnell, F.; Lauenstein, G.; and Kannan, K.; Marine Pollution Bulletin, 64, 2012, 2211-2218. 26. Peng, X.; Jin, J.; Wang, C.; Ou, W.; Tang, C.; Journal of Chromatography A, 1384, 2015, 97-106. 27. Wick, A.; Jacobs, B.; Kunkel, U.; Heininger, P.; Ternes, T.; Environmental Pollution, 212, 2016, 401-412. 28. Heine, L.; Franjevic, S.; Issues in Environmental Science and Technology, 36; Chemical Alternative Assessments; Hester, R., Harrison, R., Eds.; The Royal Society of Chemistry; 2013; pp 129-156. 29. Clean Production Action, GreenScreen® for Safer Chemicals, https://www.greenscreenchemicals.org. 30. Washington State Department of Ecology, Assessing Chemical Hazards with the Quick Chemical Assessment Tool (QCAT), https://ecology.wa.gov/Regulations-Permits/Guidance- technical-assistance/Preventing-hazardous-waste-pollution/Safer-alternatives/Quick-tool-for- assessing-chemicals. 31. Clean Production Action, GreenScreen List Translator™, https://www.greenscreenchemicals.org/learn/greenscreen-list-translator.
  • 13. © 2021 James H. Botkin dba BotkinChemie Page 13 of 22 32. Healthy Building Network, Pharos Project, https://www.pharosproject.net. 33. Office of Pollution Protection and Toxics, US Environmental Protection Agency, TSCA Work Plan Methods Document, February 2012, https://www.epa.gov/assessing-and-managing- chemicals-under-tsca/tsca-work-plan-methods-document. 34. Botkin, J.; Stone, A.; “GreenScreen® Assessment for Bumetrizole”; December 2016; https://www.slideshare.net/JimBotkin/greenscreen-assessment-bumetrizole-uv-326-casrn- 3896115.
  • 14. © 2021 James H. Botkin dba BotkinChemie Page 14 of 22 Table 1. Chemical Identity of Benzotriazole UV Absorbers. Generic Name Chemical Name CAS No. Chemical Structure UV-P 2-(2H-Benzotriazol-2-yl)-p-cresol 2440-22-4 UV-234 2-(2H-Benzotriazol-2-yl)-4,6- bis(1-methyl-1- phenylethyl)phenol 70321-86-7 UV-320 2-Benzotriazol-2-yl-4,6-di-tert- butylphenol 3846-71-7 UV-326 2-tert-Butyl-4-methyl-6-(5- chlorobenzotriazol-2-yl)phenol 3896-11-5 UV-327 2,4-Di-tert-butyl-6-(5- chlorobenzotriazol-2-yl)phenol 3864-99-1 UV-328 2-(2H-Benzotriazol-2-yl)-4,6-di- tert-pentylphenol 25973-55-1 UV-329 2-(2H-Benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol 3147-75-9 UV-350 2-(2H-Benzotriazol-2-yl)-4-(tert- butyl)-6-(sec-butyl)phenol 36437-37-3 UV-360 2,2'-Methylenebis(6-(2H- benzotriazol-2-yl)-4-(1,1,3,3- tetramethylbutyl)phenol) 103597-45-1 UV-928 2-(2H-1,2,3-benzotriazol-2-yl)-6- (2-phenylpropan-2-yl)-4-(2,4,4- trimethylpentan-2-yl)phenol 73936-91-1
  • 15. © 2021 James H. Botkin dba BotkinChemie Page 15 of 22 Table 2. Hazard Scoring Summary for UV-328 and Alternatives. Acute Toxicity Carc. Muta. Repr. Tox Dev. Tox Neurotox. Chronic Toxicity Resp. Sens. Aquatic Acute Aquatic Chronic Hazard Score UV-P 1 1 1 1 1 - 2 - 1 3 3 UV-234 1 - 1 - 1 - 2 - 1 1 2 UV-326 1 1 1 1 1 - 1 - 1 1 1 UV-328 1 - 1 2 1 - 3 - 1 - 3 UV-329 1 - 1 1 1 - 2 - 1 1 2 UV-360 1 - 1 1 1 - 1 - 1 1 1 UV-928 1 - 1 - 1 - 1 - 1 1 1 Notes: Endpoint scores and Hazard Scores given in italics are deemed to be of low confidence.
  • 16. © 2021 James H. Botkin dba BotkinChemie Page 16 of 22 Table 3. Acute Toxicity Data for UV-328 and Alternatives. Generic Name Oral LD50 Reliability Score Inhalation LC50 Reliability Score Dermal LD50 Reliability Score Hazard Score UV-P Rat, 10,000 mg/kg Mouse, >5,000 mg/kg Rat, >5,000 mg/kg Mouse, 6,500 mg/kg Rat, >15,380 mg/kg Mouse, >5,500 mg/kg 2 4 4 4 3 4 Rat (4 h), >0.59 mg/L Rat (1.2 h), >163 mg/L Rat (4 h), >1.42 mg/L 2 4 4 Rat, >2,000 mg/kg Unk., >3,038 mg/kg Rat, >1,000 mg/kg 4 3 2 1 UV-234 Rat, >7,750 mg/kg 2 No data - Rat, >2,000 mg/kg 1 1 UV-326 Rat, >2,000 mg/kg Rat, >7,750 mg/kg Mouse, >5,000 mg/kg Rat, >5,000 mg/kg Rat, >2,110 mg/kg 1 2 4 4 2 Rat (4 h), >0.27 mg/L 3 Rat, >2,000 mg/kg 2 1 UV-328 Rat, >7,750 mg/kg Rat, >2,000 mg/kg Rat, >7,100 mg/kg Mouse, >5,000 mg/kg Rat, >5,000 mg/kg 2 2 2 2 2 Rat (4 h), >0.4 mg/L Rat (1 h) > 0.129 mg/L 2 2 Rabbit, >1,100 mg/kg 2 1 UV-329 Rat, >10,000 mg/kg 2 No data - Rabbit, >5,000 mg/kg 2 1 UV-360 Rat, >2,000 mg/kg Rat, >5,000 mg/kg - 2 No data - Rat, >2,000 mg/kg - 1 UV-928 Rat, >2,000 mg/kg Rat, >2,000 mg/kg Rat, >5,000 mg/kg 1 1 1 No data - Rat, >2,000 mg/kg Rat, >2,000 mg/kg Rabbit, >2,000 mg/kg 1 1 1 1 Notes: The benzotriazole UV absorbers generally present low acute toxicity by the oral and dermal routes, but only limited data are available for the inhalation route. Data with a reliability score of 3 were deemed to be not reliable and were not used to determine the score. Applying the TSCA Work Plan Chemical Scoring criteria yields a score of 1 (low) for all seven substances.
  • 17. © 2021 James H. Botkin dba BotkinChemie Page 17 of 22 Table 4. Carcinogenicity and Mutagenicity/Genotoxicity Data for UV-328 and Alternatives. Generic Name Carcinogenicity Reliability Score Hazard Score Mutagenicity/Genotoxicity Reliability Score Hazard Score UV-P Rat, OECD 452, negative Mouse, OECD 451, negative 1 1 1 OECD 476, negative OECD 471, negative in vitro gene mutation in bacteria, negative in vitro gene mutation in bacteria, negative in vitro gene mutation in bacteria, negative 1 1 3 3 3 1 UV-234 No data - - OECD 471, negative OECD 482, negative OECD 474, negative EPA OTS 798.5915, negative 2 2 2 2 1 UV-326 Mouse, OECD 451, negative Rat, OECD 453, negative 2 2 1 OECD 473, negative OECD 471, negative OECD 471, negative OECD 478, negative OECD 474, negative OECD 475, negative 1 1 2 2 2 2 1 UV-328 No data - - OECD 471, negative OECD 473, negative OECD 476, negative 2 1 1 1 UV-329 No data - - OECD 471, negative OECD 473, negative OECD 476, negative in vitro DNA damage / repair study, negative 2 1 1 4 1 UV-360 No data - - OECD 471, negative OECD 473, negative OECD 476, negative - - - 1 UV-928 No data - - OECD 471, negative OECD 473, negative OECD 476, negative OECD 471, negative 1 1 1 1 1 Notes: UV-P and UV-326 are deemed to be negative for carcinogenicity based on the results of 2-year studies in rats and mice. Applying the TSCA Work Plan Chemical Scoring criteria yields a score of 1 (low) for UV-P and UV-326. For the other substances no score could be assigned due to lack of data. No positive results for mutagenicity/genotoxicity were obtained for UV-328 or the alternatives. Applying the TSCA Work Plan Chemical Scoring criteria yields a score of 1 (low) for all seven substances.
  • 18. © 2021 James H. Botkin dba BotkinChemie Page 18 of 22 Table 5. Reproductive and Developmental Toxicity Data for UV-328 and Alternatives. Generic Name Reproductive Toxicity Reliability Score Hazard Score Developmental Toxicity Reliability Score Hazard Score UV-P OECD 422 (rat), NOAEL 300 mg/kg/d 1 1 OECD 414 (rat), NOAEL 1,000 mg/kg/d OECD 414 (mouse), NOEL 1,000 mg/kg/d 2 1 1 UV-234 Not deemed to be toxic to reproduction based on a lack of reproductive effects observed in 28 and 90-day repeated dose studies (rats), and in an OECD 414 study. However, this may not be sufficient to assign a score under the TSCA Work Plan Chemical Scoring criteria, and no hazard score was assigned. - - OECD 414 (rat), NOEL 3,000 mg/kg/d 2 1 UV-326 OECD 422 (rat), NOAEL 1,000 mg/kg/d 1 1 OECD 414 (rat), NOAEL 3,000 mg/kg/d OECD 414 (mouse), NOAEL 3,000 mg/kg/d 2 1 UV-328 OECD 422 (rat), NOEL 250 mg/kg/d (read across from structural analog) 2 2 OECD 414 (rat), NOAEL 1,000 mg/kg/d 2 1 UV-329 OECD 422 (rat), NOAEL 300 mg/kg/d (read across from structural analog) 2 1 OECD 414 (rat), NOAEL 1,000 mg/kg/d (read across from structural analog) 2 1 UV-360 OECD 415 (rat), NOEL 300 mg/kg/d Fertility study (rat), NOEL 1,000 mg/kg/d One generation study (rat), NOEL 1000 mg/kg/d - - - 1 OECD 414 (rat), NOAEL 1,000 mg/kg/d - 1 UV-928 No data - - OECD 414 (rat), NOAEL 3,000 mg/kg/d (read across from structural analog) 2 1 Notes: No reproductive toxicity data were available for UV-234 and UV-928, and therefore no score was assigned. The scores for the other substances were obtained by applying the TSCA Work Plan Chemical Scoring criteria to the NOAEL or NOEL values from the studies. UV-328 was assigned a score of 2 (medium), and the remaining substances (UV-P, UV-326, UV-329, UV-360) were assigned scores of 1 (low). The scores for UV-328 and UV-329 were deemed to be of low confidence since they are based on structural analog data.
  • 19. © 2021 James H. Botkin dba BotkinChemie Page 19 of 22 Table 6. Chronic Toxicity Data for UV-328 and Alternatives. Chronic Toxicity Reliability Score Hazard Score UV-P OECD 422, rat, 42-53 d, NOAEL = 30 mg/kg/d OECD 409, dog, 90 d, NOEL = 33 mg/kg/d OECD 452, rat, 104 wk, NOEL = 1,000 ppm OECD 408, rat, 90 d, NOEL = 2,000 ppm OECD 409, dog, 90 d, NOEL = 1000 ppm No guideline, rat, 6 d/wk for 4 wk, NOEL = 2,500 ppm 1 3 1 2 1 3 2 UV-234 OECD 408, rat, 90 d, NOAEL = 22.3 mg/kg/d OECD 407, rat, 28 d, NOAEL = 933.8 mg/kg/d 2 2 2 UV-326 OECD 408, rat, 90 d, NOAEL = 637-740 mg/kg/d OECD 422, rat, 42-53 d, NOAEL = 1000 mg/kg/d OECD 453, rat, 104 wk, NOEL = 113.2-147.7 mg/kg/d OECD 409, dog, 90 d, NOAEL = 153-168 mg/kg/d OECD 407, rat, 28 d, NOAEL = 1,005.7 mg/kg/d OECD 451, mouse, 104 wk, NOAEL = 59-62 mg/kg/d No guideline, rat, 28 d, NOAEL = 500 ppm 2 1 2 2 2 2 3 1 UV-328 OECD 408, rat, 90 d, no NOAEL, LOAEL = 10 mg/kg/d OECD 409, Dog, 90 d, NOAEL = 30 mg/kg/d 2 2 3 UV-329 OECD 422, rat, 42-53 d, NOAEL = 30 mg/kg/d (structural analog) OECD 452, rat, 104 wk, NOAEL = 142-169 mg/kg/d (structural analog) No guideline, rat, 28 d, NOAEL = 5,658 mg/kg/d 2 2 3 2 UV-360 OECD 408, rat, 90 d, NOAEL = 1,000 mg/kg/d OECD 411, rat, 90 d, NOEL = 1,000 mg/kg/d OECD 407, rat, 28 d, NOEL = 1,000 mg/kg/d - - - 1 UV-928 OECD 408, rat, 90 d, NOEL = 1,000 mg/kg/d OECD 408, rat, 90 d, NOAEL = 1,000 mg/kg/d OECD 407, rat, 28 d, NOEL = 1,000 mg/kg/d 1 2 2 1 Notes: The chronic toxicity scores were obtained by applying the TSCA Work Plan Chemical Scoring criteria to the NOAEL or NOEL values from the studies. Data with a reliability score of 3 were deemed to be not reliable and were not used to determine the score. UV-328 was assigned a score of 3 (high), UV-P and UV-234 were assigned scores of 2 (medium), and the remaining substances (UV-326, UV-329, UV-360, UV-928) were assigned scores of 1 (low). The score for UV-329 was deemed to be of low confidence since it was based on structural analog data.
  • 20. © 2021 James H. Botkin dba BotkinChemie Page 20 of 22 Table 7. Acute and Chronic Aquatic Toxicity Data for UV-328 and Alternatives. Generic Name Acute Aquatic Toxicity Reliability Score Hazard Score Chronic Aquatic Toxicity Reliability Score Hazard Score UV-P Fish (96 h), LC50 > 0.17 mg/L Fish (96 h), LC50 > 100 mg/L Fish (48 h), LC50 > 200 mg/L Daphnia (24 h), EC50 > 1,000 mg/L Algae (72 h), ErC50 > 0.0822 mg/L 1 2 2 2 1 1 Daphnia (21 d), NOEC = 0.013 mg/L 1 3 UV-234 Fish (96 h), LC50 > 67 mg/L Daphnia (48 h), EC50 > 100 mg/L Daphnia (24 h), LC50 > 10 mg/L Daphnia (24 h), EC50 > 91 mg/L Algae (72 h), EC50 > 100 mg/L 2 1 4 3 2 1 Daphnia (21 d), NOEC ≥ 10 mg/L 1 1 UV-326 Fish (96 h), LC50 > 100 mg/L Daphnia (48 h), EC50 > 100 mg/L Daphnia (48 h), LC50 > 10 mg/L Daphnia (24 h), EC50 > 100 mg/L Algae (24 h), EC50 > 100 mg/L 2 1 4 3 2 1 Daphnia (21 d), NOEC ≥ 10 mg/L 1 1 UV-328 Fish (96 h), LC50 > 100 mg/L Fish (96 h), LC50 > 0.078 mg/L Daphnia (48 h), LC50 > 10 mg/L Daphnia (24 h), EC50 > 100 mg/L Daphnia (48 h), EC50 > 0.083 mg/L Algae (72 h), ErC50 > 0.016 mg/L Algae (72 h), EC50 > 10 mg/L 2 2 4 4 2 2 2 1 No data - - UV-329 Fish (96 h), EC50 >100 mg/L Daphnia (48 h), EC50 > 100 mg/L Daphnia (48 h), LC50 > 10 mg/L Daphnia (24 h), EC50 = 15 mg/L Algae (72 h), EC50 > 100 mg/L 2 1 4 3 2 1 Daphnia (21 d), NOEC ≥ 10 mg/L 1 1 UV-360 Fish (96 h), LC50 > 28.9 mg/L Fish (96 h), LC50 > 10 mg/L Fish (96 h), LC50 > 12.7 mg/L Daphnia (48 h), LC50 > 65.9 mg/L Daphnia (48 h), EC50 > 50.2 mg/L - - - - 2 1 Fish (8 wk), NOEC > 1 mg/L Daphnia (21 d), NOEC > 0.025 mg/L - - 1
  • 21. © 2021 James H. Botkin dba BotkinChemie Page 21 of 22 Daphnia (24 h), LC50 > 100 mg/L Daphnia (48 h), EC50 > 100 mg/L Algae (72 h), EC50 > 2 mg/L Algae (72 h), EC50 > 2 mg/L - - - 2 UV-928 Fish (96 h), LC50 > 0.33 mg/L Fish (96 h), LC50 > 0.21 mg/L Daphnia (48 h), EC50 > 0.9 mg/L Algae (72 h), ErC50 > 0.66 mg/L Algae (72 h), ErC50 > 0.41 mg/L 1 1 1 1 1 1 Daphnia (21 d), NOEC ≥ 2 mg/L 1 1 Notes: Applying the TSCA Work Plan Chemical Scoring criteria yields an acute aquatic toxicity score of 1 (low) for all seven substances. Data with a reliability score of 3 were deemed to be not reliable and were not used to determine the score. No chronic aquatic toxicity data were available for UV-328 and therefore no score was assigned. The chronic toxicity scores for the other substances were obtained by applying the TSCA Work Plan Chemical Scoring criteria to the NOEC values from the studies. UV-P was assigned a chronic aquatic toxicity hazard score of 3 (high), and the remaining five substances (UV-234, UV-326, UV-329, UV-360, UV-928) were assigned chronic aquatic toxicity hazard scores of 1 (low).
  • 22. © 2021 James H. Botkin dba BotkinChemie Page 22 of 22 Table 8. Bioaccumulation Scores, Persistence Scores, Total Scores, and Annex XIII Classifications for UV-328 and Alternatives. BCF Reliability B Score P Score PB Score Hazard Score Total Score Annex XIII Classification UV-P 1,456-1,623 44-494 1 2 2 3 3 3 6 not PBT, not vPvB UV-234 415-1,286 5.4-10.4 1 3 2 3 3 2 5 not PBT, not vPvB UV-326 6,356-7,093 54-895 1 2 3 3 3 1 4 vPvB, not PBT UV-328 1,120-5,580 570-1,800 2 2 3 3 3 3 6 PBT, vPvB UV-329 361-461 1 1 3 2 2 4 not PBT, not vPvB UV-360 0.1-1.5 - 1 3 2 1 3 not PBT, not vPvB UV-928 415-1,286 361-461 6-27 1 1 2 2 3 3 1 4 not PBT, not vPvB Notes: The Bioaccumulation (B) scores were obtained by applying the TSCA Work Plan Chemical Scoring criteria to the maximum BCF values from the REACH dossiers. UV-328 and UV-326 received a B Score of 3 (high); UV-P, UV-234 and UV-928 received B Scores of 2 (medium), and the remaining substances (UV-329, UV-360) received B Scores of 1 (low). The B Score for UV-928 was deemed to be of low confidence as it was based on structural analog data and is given in italics. All of the benzotriazoles were assumed to be highly persistent and assigned Persistence (P) Scores of 3 (high). The B and P Scores were normalized according to the TSCA Work Plan Chemical Scoring method to PB Scores. UV-P, UV-234, UV-326. UV-328, and UV-928 received PB Scores of 3 (high), and the remaining substances (UV-329, UV-360) received PB Scores of 2 (medium). The PB Score for UV-928 was deemed to be of low confidence since the underlying B Score was based on structural analog data, and is given in italics. The PB and Hazard Scores (from Table 2) were added together to give a Total Score. UV-P and UV-328 received a Total Score of 6 (very high); UV-234 received a Total Score of 5 (high); UV-326, UV-329 and UV-928 received Total Scores of 4 (medium), and UV-360 received a Total Score of 3 (medium-low). The Total Scores for UV-329 and UV-928 were deemed to be of low confidence since the underlying B and/or Hazard Scores were based on structural analog data, and are given in italics. The benzotriazoles were also rated according to the REACH Annex XIII criteria for PBT and vPvB chemicals. Based on the available data, UV- 328 met the criteria for PBT and vPvB, and UV-326 met the criteria for vPvB.