CLP criteria for hazard classification of substances and mixtures

1. TA Project: Chemical Safety in Croatia  Workshop 16-17 June 2011 Lennart Dock Swedish Chemicals Agency CLP criteria for hazard classification of substances and mixtures

2. Physical Hazards CLP Hazard Class Hazard Category Explosives Unstable Div1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6 Flammable Gases 1 2 Flammable Aerosols 1 2 Oxidising Gases 1 Gases under pressure Compressed gas Liquefied gases Refrigerated liquefied gases Dissolved gases Flammable Liquids 1 2 3 Flammable Solids 1 2 Self Reactive Chemicals Type A Type B Type C Type D Type E Type F Type G Pyrophoric Liquids 1 Pyrophoric Solids 1 Self Heating Chemicals 1 2 Water Reactive - emits Flammable Gases 1 2 3 Oxidising Liquids 1 2 3 Oxidising Solids 1 2 3 Organic Peroxides Type A Type B Type C Type D Type E Type F Type G Corrosive to Metals 1

3. Criteria for Physical Hazard Classification • UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria CLP Annex I, Part 2

4. Also, GHS categories/types/divisions correlates to TDG packing groups

5. Health Hazards CLP Hazard Class Hazard Category Acute Toxicity Oral Dermal Inhalation 1 2 3 4 1 2 3 4 1 2 3 4 Skin Corrosion/Irritation Corrosive Irritant 1A 1B 1C 2 Serious Eye Damage/Irritation 1 2 Respiratory or skin sensitizer 1A 1B Germ Cell Mutagenicity 1A 1B 2 Carcinogenicity 1A 1B 2 Reproductive Toxicity 1A 1B 2 Lactation STOT - Single Exposure 1 2 3 STOT - Repeated Exposure 1 2 Aspiration hazard 1

6. Criteria for Health Hazard Classification • Acute toxicity • Corrosivity/Irritation (skin and eye) • Sensitisation (respiratory/dermal) • CMR • Specific Target Organ Toxicity and Aspiration CLP Annex I, Part 3

7. Acute toxicity: substances ATE = acute toxicity estimate

8. Classification of a mixture based on the acute toxicity of the ingredients 1) Data available for all ingredients Ci 100 =∑ ATEmixture ATEi n Ci = concentration of ingredient ”i” (% w/w or % v/v) i = the individual ingredient from 1 to n n = the number of ingredients ATEi = Acute Toxicity Estimate of ingredient ”i”

9. Classification of a mixture for acute toxicity

10. Conversion from range value/category to point estimate

11. Classification of a mixture for acute toxicity Point estimate: 100 Ci 100 =∑ ATEi ATEmixture n 1 3 10 100 = + + ATEmixture = 743 225 100 100 ATEmixture classification: acute tox, cat 4

12. Skin corrosive or irritant: substances *visible necrosis through the epidermis and into the dermis

13. Skin corrosive or irritant: substances * Directive 67/548/EEC: mean value ≥ 2 (2 animals or more)

14. Skin corrosive or irritant: mixtures *The sum of alla ingredients of a mixture classified as Skin Corrosive Category 1A, 1B or 1C respectively, shall each be ≥ 5% respectively in order to classify the mixture as either Skin Corrosive Category 1A, 1B or 1C. If the sum of the Skin Corrosive Category 1A ingredients is < 5% but the sum of Category 1A+1B ingredients is ≥ 5%, the mixture shall be classified as Skin Corrosive Category 1B. If the sum of the Skin Corrosive Category 1A+1B ingredients is < 5% but the sum of of Category 1A+1B+1C ingredients is ≥ 5% the mixture shall be classified as Skin Corrosive Category 1C.

15. Skin corrosive or irritant: mixtures

16. Seriouseyedamage/eye irritation: substances

17. Seriouseyedamage/eye irritation: substances Directive 67/548/EEC: mean scores * ≥ 2 and ** ≥ 2,5

18. Effects on the eye: mixtures

19. Effects on the eye: mixtures

20. Respiratory sensitisation: substances *presently there are no recognized and validated animal models available

21. Respiratory sensitisation: mixtures *This concentration limit is generally used for the application of the special labelling requirements to protect already sensitised individuals. A SDS is required for the mixture containing an ingredient above this concentration. **This concentration limit is used to trigger classification of a mixture as a respiratory sensitiser.

22. Skin sensitisation: substances

23. Skin sensitisation: mixtures *This concentration limit is generally used for the application of the special labelling requirements to protect already sensitised individuals. A SDS is required for the mixture containing an ingredient above this concentration. **This concentration limit is used to trigger classification of a mixture as a skin sensitiser.

24. Concentration limits for elicitation of components of a mixture* *These concentration limit for elicitation is used for the application the special labelling requirements to protect already sensitised individuals. A SDS is required for the mixture containing a component above this concentration. For sensitising substances with specific concentration limit lower than 0,1%, the concentration limit for elicitation should be set at one tenth of the specific concentration limit.

25. Germ cell mutagenicity: substances

26. Germ cell mutagenicity: substances

27. Germ cell mutagenicity: mixtures

28. Carcinogenicity: substances *CLP Annex I, section 3.6.2.2 **CLP Annex I, section 3.6.2.2.4

29. Carcinogenicity: substances *CLP Annex I, section 3.6.2.2 **CLP Annex I, section 3.6.2.2.4

30. Carcinogenicity: mixtures *If a Category 2 carcinogen is present in the mixture as an ingredient at a concentration ≥ 0,1% a SDS shall be available for the mixture upon request

31. Reproductive toxicity: substances

32. Reproductive toxicity: substances

33. Lactation effects: substances

34. Reproductive toxicity: mixtures *If a Cat. 1 or Cat. 2 reproductive toxicant or a substance classified for effects on or via lactation is present in the mixture as an ingredient at a concentration >0,1%, a SDS shall be available for the mixture upon request. Dir 1999/45/EC: ≥ 0.5% [Cat 1 and 2] and ≥ 5% [Cat 3]

35. Specifictarget organ toxicity (STOT) – single exposure: substances

36. Specifictarget organ toxicity (STOT) – single exposure: substances

37. STOT SE: Guidance value ranges *The guidance values are intended for guidance purposes to be used as part of the weight-of-evidence approach and to assist in decision about classification. They are not intended as strict demarcation values.

38. STOT SE: mixtures *If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a concentration ≥ 1,0% a SDS shall be available for the mixture upon request

39. Supporting classification Not supporting classification Only change in body weight gain, food consumption or water intake Small changes (clin chem) which are of doubtful or minimal toxicological importance Changes in organ weights with no evidence of organ dysfuntion Adaptive responses (enzyme induction, liver hypotrophy, macrophage migration in the lung) Species-specific mechanism • Substance-related deaths • Major functional changes in the central or peripheral nervous systems (sight, hearing, sense of smell) or other organ systems (for example the lung) • Severe disturbances (eg haematological disturbances suggesting that they are due to decreased bone marrow production of blood cells) • Severe organ damage, especially heart, nervous system, stem cell populations

40. STOT – repeated exposure: substances

41. STOT RE: Guidance value ranges *The guidance values are intended for guidance purposes to be used as part of the weight-of-evidence approach and to assist in decision about classification. They are not intended as strict demarcation values.

42. STOT RE: mixtures *If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a concentration ≥ 1,0% a SDS shall be available for the mixture upon request

43. Aspiration hazard • Aspiration: • Entry of a liquid or solid chemical product directly through the oral or nasal • cavity, or from vomiting, into the trachea and lower respiratory system. • Hazard: • May result in chemical pneumonia, varying • degrees of pulmonary injury or death following • aspiration. • Data used for classification: • Human experience (e.g. workplace) • Structure-Activity Relationship (e.g. most hydrocarbons) • Phys/chem data (dynamic or kinematic viscosity) • Animal studies (limited value)

44. Aspiration toxicity A mixture which contains a total of ≥10% of a substance or substances classified in Category 1, and has a kinematic viscosity of ≤20,5 mm2/s measured at vid 40°C, shall be classified in Category 1. In the case of a mixture which separates into two or more distinct layers, one of which contains ≥10% of a substance classified in Category 1 and has a kinematic viscosity of ≤20,5 mm2/s measured at 40°C, then the entire mixture is classified in category 1. Directive 67/548/EEC: < 7 x 10-6 m2/s (40 °C)

45. Transition from DSD to CLP will lead to reclassification of some mixtures

46. Environmental Hazards CLP Hazard Class Hazard Category Hazardous to the aquatic environment 1 Acute hazard + 1 2 3 4 Chronic (Long-term) hazard Hazardous to the ozone layer 1 Note: GHS Categories Acute 2 and Acute 3 are not normally used when considering packaged goods, (but for transport of bulk quantities). Therefore, not part of the EU - Supply and Use system.

47. Criteria for Environmental Hazard Classification • Hazardous to the aquatic environment • Acute (short-term) hazard • Long-term hazard • Hazardous to the ozone layer CLP Annex I, Part 4 CLP Annex I, Part 5

48. Environmental hazards • Acute (short-term) aquatic hazard • The hazard of a chemical caused by its acute toxicity to an organism during short-term aquatic exposure to that chemical. • Long-term aquatic hazard • The hazard of a chemical caused by its chronic toxicity following long-term exposure in the aquatic environment. Note! Acute & Long-term hazards ≠ Acute & chronic toxicity

49. Criteria for Acute (short-term) aquatic hazard Based on ACUTE (or SHORT-TERM) AQUATIC TOXICITY Acute toxicity to Fish and/or Crustacea and/or Aquatic plant Lowest value ≤1 mg/l CATEGORY: ACUTE 1

50. Multiplying (M) factors • The classifier shall set an M-factor if a substance is classified as Acute1 • Components classified as Acute 1 may have LC50 or EC50 values well below 1 mg/l which influence the toxicity of a mixture and should be given increased weight. M-factors are used in the calculation method for classification of a mixture