Analysis of cosmetics, toxicity screening and test methods

1. Presented by: Swati Wadhawan
M. Pharm 1st yr
ANALYSIS OF COSMETICS,
TOXICITY SCREENING AND
TEST METHODS

2. DRUG AND COSMETIC ACT
 The Drugs and Cosmetics Act, 1940 is an Act of
the Parliament of India which regulates the import,
manufacture and distribution of drugs in India.
 It consist of 168 rules and XIX subpart .Drug and
cosmetic act contain schedules A to Y

3. Types Cosmetics Formulations
 Creams, emulsions, lotions, gels and oils for skin
 Products for care of the teeth and the mouth
 Deodorants and anti-perspirants
 Toilet soaps, deodorant soaps
 Perfumes, toilet water
 Shaving product
 Depilatories etc.

4. Analysis of cosmetics
 Physical Evaluation
 Chemical evaluation
 Microbiological evaluation

5. 1. Physical evaluation
 RHEOLOGY
Rheological characterization of materials includes polymers,
liquids, adhesives and other samples using a wide range of
shear and extensional conditions
Rheology tests
 Melt Flow Rate
 Melt Flow Index
 Capillary Rheometry Shear Sweep
 Thermal Stability

6. 2. PHYSICAL/ CHEMICAL STABILITY TESTING
These describes approaches to predicting how well cosmetics
will resist common stresses such as tmperature extremes and
light. Common test procedures include
 Temperature Variations
 Cycle Testing
 Centrifuge Testing
 Light Exposure Testing
 Mechanical Shock Testing
 Monitoring

7.  Microbial stability testing
Microbial preservation of cosmetics is important to ensure the
microbial safety of cosmetics for the consumer, maintain the
quality of the product, and confirm hygienic and high-quality
handling
 Screening Tests
 Quantitative Tests

8.  Packaging of stability testing
Packaging can directly affect finished product stability
because of interactions which can occur between the
product, the package, and the external environment
 Glass Tests
 Weight Loss Tests
 Leaking Tests
 Viscosity
 Particle size

9. Chemical evaluation
i) DETERMINATION OF TOTAL FATTY SUBSTANCE
CONTENT
ii) DETERMINATION OF RESIDUE
iii) TEST FOR HEAVY METALS
iv) DETERMINATION OF ARSENIC

10. i) Determination of total fatty
substance content
Principle of the method
The emulsion is broken with dilute mineral acid and the fatty matter
is extracted with petroleum ether. It is weighed after removal of the
Solvent
REAGENTS
1 Dilute Hydrochloric Acid
2 Petroleum Ether
3 Methyl Orange Indicator Solution
4 Sodium Sulphate

11. ii) DETERMINATION OF RESIDUE
PROCEDURE
 Weigh accurately about 5 g of the material in a weighed,
clean and dry squat form weighing bottle and
 Residue percent by mass = 100; dry to constant mass at
105 ± 1 ºC. Cool in a desiccators and weigh.

12. iii) TEST FOR HEAVY METALS
Outline of the method
The colour produced with hydrogen sulphide solution is matched
against that obtained with standard lead solution.
APPARATUS
1 Nessler Cylinders — 50-ml capacity
REAGENTS
1 Dilute Hydrochloric Acid
2 Dilute Acetic Acid
3 Dilute Ammonium Hydroxide
4 Hydrogen Sulphide Solution
5 Standard Lead Solution

13. iv) DETERMINATION OF ARSENIC
OUTLINE OF THE METHOD
Arsenic present in a solution of the material is reduced to arsine,
which is made to react with mercuric bromide paper. The stain
produced is compared with a standard stain.
REAGENTS
1 Mixed Acid
2 Ferric Ammonium Sulphate Solution
3 Concentrated Hydrochloric Acid
4 Stannous Chloride Solution

14. 3) MICROBIOLOGICAL EVALUATION
To ensure the quality and product safety of cosmetics it is
necessary to evaluate the product or its components with
defined microbiological tests.
 Determination of the Bioburden
 Testing of Efficacy of Preservation
 Stability Testing

15. Requirements to quality management
 Document
 Personnel
 Environment
 Test and calibration methods and method validation
 Equipment
 Reagents and culture media
 Internal quality control
 External quality assessment (proficiency testing)

16. TOXICITY STUDIES
 The determination of toxic potential is the first step in the
hazard assessment of an ingredient and consists of a series
of toxicity studies, specific to distinct toxicological end
points
 The in vitro methodologies for evaluating the toxic
potential of ingredients reported in the literature
 In vivo studies to investigate the toxicological profile of
a cosmetic ingredient when applied to an animal by a
route of exposure similar to that of human exposure

17. ACUTE TOXICITY
 Two oral in vivo acute toxicity methods recently adopted by
OECD (organization for economic cooperation &
development)
 The OECD group of national co-ordinators proposes
inclusion in the text of Guideline 401
 In the Annex 1 to these guidelines, the SCCNFP stresses that
acute toxicity data only have to be provided when they are
already available

18. PERCUTANEOUS ABSORPTION
 Percutaneous absorption may be defined as the movement of
a chemical substance applied to the surface of the skin into
the circulatory system
 The percutaneous absorbed dose is the amount of a chemical
which is systemically distributed

19. SKIN IRRITATION
 There are to date no validated alternative methods capable of
replacing the OECD 404 in vivo skin irritation test
 ECVAM (European center for the validation of alternative
methods) has concluded positively the validation of 2 in vitro
methods to assess the skin corrosivity potential of different
chemicals

20. EYE IRRITATION
The international EC/Home Office validation study of
alternatives to the Draize eye irritancy test did not achieve
the expected objectives but triggered the organisation of an
ECVAM workshop on the practical aspects of validation
and the preparation of a prevalidation schedule, as well as
the planning of the COLIPA (European cosmetic, toiletry
and perfumery association) study

21. SKIN SENSITISATION AND PHOTOSENSITISATION
 Concerning skin sensitization a proposal for developing an in
vitro test for the detection of the sensitizing potential of
chemical substances
SUBCHRONIC TOXICITY
 development of ingredients evaluated by the SCCNFP
(Scientific committee on cosmetic & non-food products)
which have specific biological properties
 Evaluation of the systemic risk is a key element in evaluating
the safety of new ingredients

22. MUTAGENICITY/GENOTOXICITY
 Several in vitro genotoxicity tests are available. the
combination of two in vitro tests:
1. Bacterial reverse mutation test (or in vitro mammalian
cell gene mutation test for specific chemicals, for which a
scientific justification must be provided)
2. In vitro mammalian cell chromosome aberration test
provides in general sufficient evidence of mutagenic
and/or genotoxic potential
Use of in vivo tests is limited to confirmation of a
mutagenic activity already observed in Vitro

23. PHOTOTOXICITY/PHOTOIRRITATION
 All chemicals which are able to absorb UVA and/or UVB
light, may change their molecular configuration and may
undergo further biological reaction of toxicological
relevance for consumers
 Animal models have not been validated for testing for
phototoxicity
 The principle of the method is based on a comparison of the
cytotoxicity of a chemical

24. PHOTOMUTAGENICITY PHOTOGENOTOXICITY
 In 1990 the SCC (standard coordinating committee) adopted
guidelines for testing the photomutagenicity /
photogenotoxicity of UV radiation absorbing cosmetic
ingredients
 Since 1990, COLIPA has submitted dossiers on UV filters
containing photomutagenicity data obtained from different
types of tests

25. References
 https://www2.mst.dk/udgiv/publications/2010/978-87-92668-
66-0/pdf/978-87-92668-67-7.pdf
 http://www.chemeng.lth.se/exjobb/E28
 www.mdpi.com/journal/cosmetics/special_issues/quality-
control-cosmetics
 https://www.lctech.de/fileadmin/user_upload/.../LCTech-
Flyer-Cosmetics-en.pdf
 ec.europa.eu/health/ph_risk/committees/sccp/documents/out1
30_en.
 https://www.ufag-laboratorien.ch/en/cosmetics.../quality-
control-of-products.htm