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1
Candido Mendes University
Lívia De Martin Lazzari
Bruno Vianna Do Amaral
Patrícia Da Cruz Cunha
07/09/2017
2
• Pharmaceutical industry – OHSAS 18001 (Occupational Health and Safety
Assessment Series) - requires a control of all chemical substances - certification
• Inventory of all chemical products
• Group of substances – Reference Standards (357) – highly characterized physical
specimens used in testing by pharmaceutical industry to ensure the identity,
quality and purity of drugs. One Reference Standard may be composed of one or
more substances.
• Largest group and most toxic group
3
• Fundacentro (Jorge Duprat Figueiredo Foundation for Safety and
Occupational Medicine) – Governmental Institution focused on the study
and research of work environmental conditions.
• Methodology based on International Chemical Control Toolkit (promoted
by the International Labor Organization (ILO) and the World Health
Organization (WHO))
• This methodology uses the GHS (Globally Harmonized System of
Classification and Labelling of Chemicals) to determine the substances
toxicity.
4
• Developed under Agenda 21 – document created in Eco 92 (United
Nations Conference on Environment and Development).
• The basic objective of the hazard communication is to ensure the
employers, employees and public receive adequate, practical and
understandable information about chemical hazards.
5
6
• Associate the GHS hazard classification (MSDS - Chemical Safety Data
Sheets) with the methodology toxicity classification (risk group).
• The methodology is divided in five stages in order to determined a
correct control for the risk.
• For the present study, only the first stage was used because the
objective was only to identify the substance toxicity.
7
• Substance toxicity – GHS classification – MSDS (Chemical Safety Data Sheets )
• A
• B
• C
• D
• E
• S
Health damage caused by inhalation or ingestion of the
substances. Greatest potential for causing health damage -
category E.
Damage when in contact with skin or eyes
8
• The methodology provides a table linking the GHS with Groups A to E and S.
9
10
• Several countries determine occupational exposure limits for some
chemicals that should be monitored and controlled in the work place
to prevent accidents and occupational diseases.
• In Brazil, the limits are determine by the NR-15 - Regulatory Norm
number 15 – Brazil – 1978. Those limits was based on the exposure
limits determine by the ACGIH - American Conference of
Governmental Industrial Hygienists in 1977, and this data has not
been updated since 1978.
11
• ACGIH - American Conference of Governmental Industrial Hygienists -
professional association of industrial hygienists and related
professions practitioners, located in USA – exposure limits are
permanently reviewed.
• This work tracked the reference standards that had some substance
with a tolerance limit determined by NR-15 and ACGIH
12
• Qualitative analysis - S group
• NR-15 and ACGIH also indicates this risk – just when the dermal
exposure have a significant potential contribution to the total
exposure (systematic effects)
• The qualitative analysis indicate adverse effects less severe.
13
Qualitative Analysis
33,33% highly toxic
14
Quantitative analysis
• ACGIH - 30 RS (8.40%) - 28 substances
• NR-15 – 14 RS (3.92%) – 12 substances
• Benzene exposure limit in NR-15 is 200% greater than ACGIH limit.
• Trichloroethylene exposure limit in NR-15 1000% greater than ACGIH limit.
15
NR-15 Limits and Qualitative Analysis
4,2% (119 RS highly
toxic – D or E)
16
ACGIH Limits and Qualitative Analysis
12,6% (119 RS highly
toxic – D or E)
17
18
• The present work shows that for a good chemical management,
quantitative and qualitative analysis must be done together. This is
concluded because several substances have no quantitative exposure
limits and their toxicological effects are unknown, making chemical
risk analysis purely quantitative insufficient to ensure the workers’
health and safety.
19
• Lívia Lazzari
• lvlazzari@gmail.com
• +55 27 99763-2444

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Safe 2017 safety sdkjs sdugsuyd udhuis.pptx

  • 1. 1 Candido Mendes University Lívia De Martin Lazzari Bruno Vianna Do Amaral Patrícia Da Cruz Cunha 07/09/2017
  • 2. 2 • Pharmaceutical industry – OHSAS 18001 (Occupational Health and Safety Assessment Series) - requires a control of all chemical substances - certification • Inventory of all chemical products • Group of substances – Reference Standards (357) – highly characterized physical specimens used in testing by pharmaceutical industry to ensure the identity, quality and purity of drugs. One Reference Standard may be composed of one or more substances. • Largest group and most toxic group
  • 3. 3 • Fundacentro (Jorge Duprat Figueiredo Foundation for Safety and Occupational Medicine) – Governmental Institution focused on the study and research of work environmental conditions. • Methodology based on International Chemical Control Toolkit (promoted by the International Labor Organization (ILO) and the World Health Organization (WHO)) • This methodology uses the GHS (Globally Harmonized System of Classification and Labelling of Chemicals) to determine the substances toxicity.
  • 4. 4 • Developed under Agenda 21 – document created in Eco 92 (United Nations Conference on Environment and Development). • The basic objective of the hazard communication is to ensure the employers, employees and public receive adequate, practical and understandable information about chemical hazards.
  • 5. 5
  • 6. 6 • Associate the GHS hazard classification (MSDS - Chemical Safety Data Sheets) with the methodology toxicity classification (risk group). • The methodology is divided in five stages in order to determined a correct control for the risk. • For the present study, only the first stage was used because the objective was only to identify the substance toxicity.
  • 7. 7 • Substance toxicity – GHS classification – MSDS (Chemical Safety Data Sheets ) • A • B • C • D • E • S Health damage caused by inhalation or ingestion of the substances. Greatest potential for causing health damage - category E. Damage when in contact with skin or eyes
  • 8. 8 • The methodology provides a table linking the GHS with Groups A to E and S.
  • 9. 9
  • 10. 10 • Several countries determine occupational exposure limits for some chemicals that should be monitored and controlled in the work place to prevent accidents and occupational diseases. • In Brazil, the limits are determine by the NR-15 - Regulatory Norm number 15 – Brazil – 1978. Those limits was based on the exposure limits determine by the ACGIH - American Conference of Governmental Industrial Hygienists in 1977, and this data has not been updated since 1978.
  • 11. 11 • ACGIH - American Conference of Governmental Industrial Hygienists - professional association of industrial hygienists and related professions practitioners, located in USA – exposure limits are permanently reviewed. • This work tracked the reference standards that had some substance with a tolerance limit determined by NR-15 and ACGIH
  • 12. 12 • Qualitative analysis - S group • NR-15 and ACGIH also indicates this risk – just when the dermal exposure have a significant potential contribution to the total exposure (systematic effects) • The qualitative analysis indicate adverse effects less severe.
  • 14. 14 Quantitative analysis • ACGIH - 30 RS (8.40%) - 28 substances • NR-15 – 14 RS (3.92%) – 12 substances • Benzene exposure limit in NR-15 is 200% greater than ACGIH limit. • Trichloroethylene exposure limit in NR-15 1000% greater than ACGIH limit.
  • 15. 15 NR-15 Limits and Qualitative Analysis 4,2% (119 RS highly toxic – D or E)
  • 16. 16 ACGIH Limits and Qualitative Analysis 12,6% (119 RS highly toxic – D or E)
  • 17. 17
  • 18. 18 • The present work shows that for a good chemical management, quantitative and qualitative analysis must be done together. This is concluded because several substances have no quantitative exposure limits and their toxicological effects are unknown, making chemical risk analysis purely quantitative insufficient to ensure the workers’ health and safety.
  • 19. 19 • Lívia Lazzari • lvlazzari@gmail.com • +55 27 99763-2444