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Environmental GHS for Beginners

Environmental GHS for Beginners. - Substances - Mixtures – Hazard Communication -. GHS Classification of Substances. Scope & Rationale. Intrinsic hazards to aquatic organisms 3 acute categories & 4 chronic categories applied independently – basis for use in all regulatory systems

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Environmental GHS for Beginners

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  1. Environmental GHS for Beginners - Substances - Mixtures – Hazard Communication -

  2. GHS Classification of Substances

  3. Scope & Rationale • Intrinsic hazards to aquatic organisms • 3 acute categories & 4 chronic categories applied independently – basis for use in all regulatory systems • Acute hazard category assigned using acute data • Chronic hazard category assigned using acute data in conjunction with potential for long-term exposure (i.e. lack of rapid degradability) and/or potential to bioaccumulate • Declassification of chronic hazard possible through use of chronic data

  4. Data Elements for Classification • Acute aquatic toxicity – representative species e.g. • fish 96 h LC50; crustacea 48 h EC50; algae 72 or 96 h ErC50 • Bioaccumulation potential • log Kow or Bioconcentration Factor (BCF) • Rapid degradability • Ready biodegradability; BOD5/COD ≥ 0.5; other evidence for rapid degradation • Chronic toxicity – relevant species e.g. • Fish Early Life Stage; Daphnia reproduction; Algal Growth Inhibition

  5. Acute I • 96 h LC50 (for fish) £1 mg/L and/or • 48 h EC50 (for crustacea) £1 mg/L and/or • 72 or 96 h ErC50 (for £1 mg/L algae or other aquatic plants) • Acute I may be subdivided for some regulatory systems to include a lower band at L(E)C50£0.1mg/L

  6. Acute II • 96 h LC50 (for fish) >1 - £10 mg/L and/or • 48 h EC50 (for crustacea) >1 - £10 mg/L and/or • 72 or 96 h ErC50 (for >1 - £10 mg/Lalgaeor other aquatic plants)

  7. Acute III • 96 h LC50 (for fish) >10 - £100 mg/L and/or • 48 h EC50 (for crustacea) >10 - £100 mg/L and/or • 72 or 96 h ErC50 (for >10 - £100 mg/L algae or other aquatic plants) • Some regulatory systems may extend this range beyond an L(E)C50 of 100 mg/L through the introduction of another category

  8. Chronic I • 96 h LC50 (for fish) £1 mg/L and/or • 48 h EC50 (for crustacea) £1 mg/L and/or • 72 or 96 h ErC50 (for £1 mg/L algae or other aquatic plants) AND • the substance is not rapidly degradable and/or the log Kow³4 (unless the experimentally determined BCF <500).

  9. Chronic II • 96 h LC50 (for fish) >1 - £10 mg/L and/or • 48 h EC50 (for crustacea) >1 - £10 mg/L and/or • 72 or 96 h ErC50 (for>1 - £10 mg/L algae or other aquatic plants) AND • the substance is not rapidly degradable and/or the log Kow³4 (unless the experimentally determined BCF <500) • unless the chronic toxicity NOECs are >1 mg/L for the species showing acute toxicity

  10. Chronic III • 96 h LC50 (for fish) >10 - £100 mg/L and/or • 48 h EC50 (for crustacea) >10 - £100 mg/L and/or • 72 or 96 h ErC50 (for >10 - £100 mg/L algae or other aquatic plants) AND • the substance is notrapidlydegradable and/or the log Kow³4 (unless the experimentally determined BCF <500) • unless the chronic toxicity NOECs are >1 mg/L for the species showing acute toxicity

  11. Chronic IV • ‘Safety Net’ classification for poorly soluble substances (normally substances with solubility >1 mg/L) • no acute toxicity at levels up to the water solubility, AND • not rapidly degradable, AND • log Kow³4 • Classified unless • experimentally determined BCF <500, OR • chronic toxicity NOECs>1 mg/L (or > solubility), OR • evidence of rapid degradation in the environment

  12. Proposal on chronic hazards • In the adoption process at OECD. • To be submitted to the UN Sub-Committee of Experts on the GHS • Surrogate chronic system: acute + persistency or bioacumulation potential • Surrogate system to be superseded when experimental chronic NOECs/ECx values are available

  13. Proposed flowchart submitted to the UN Sub-Committee of Experts

  14. Notes • Provisional classification if acute toxicity data are available for <3 species • Declassification from chronic categories II & III requires chronic data with NOECs >1 mg/L for species in which acute toxicity data resulted in classification • Declassification from chronic class IV requires chronic data with NOECs > water solubility

  15. Examples • Substance X • Fish LC50 9.7mg/L; Daphnia EC50 20mg/L; Algae ErC50 82mg/L • Biodegradability <5% in OECD 301 • log Kow 2.7 • Classification • Acute toxicity in range >1 - £10 mg/L • Not rapidly degradable (therefore log Kow < 4 is not taken into account) • No BCF or chronic toxicity data • Therefore assign: Acute II & Chronic II

  16. Variations on Substance X • Substance X – variation 1 • Fish LC50 9.7mg/L; Daphnia EC50 20mg/L; Algae ErC50 82mg/L • Daphnia reproduction study NOEC >1mg/l • Biodegradability <5% in OECD 301 • log Kow 2.7 • Classification • Acute toxicity in range >1 - £10 mg/L (fish) • Not rapidly degradable (therefore log Kow <4 is not taken into account) • No BCF, but chronic NOEC >1 mg/L (Daphnia) • Therefore assign: Acute II & Chronic II would need fish NOEC to declassify

  17. Variations on Substance X • Substance X – variation 2 • Fish LC50 9.7mg/L; Daphnia EC50 20mg/L; Algae ErC50 82mg/L • Fish Early Life Stage study NOEC > 1mg/l • Biodegradability <5% in OECD 301 • log Kow 2.7 • Classification • Acute toxicity in range >1 - £10 mg/L (fish) • Not rapidly degradable (therefore log Kow <4 is not taken into account) • No BCF, but chronic NOEC >1 mg/L (fish) • Therefore assign: Acute II not Chronic II due to fish NOEC >1 mg/l

  18. Variations on Substance X • Substance X – variation 3 • Fish LC50 9.7mg/L; Daphnia EC50 20mg/L; Algae ErC50 82mg/L • Biodegradability – no data • log Kow 2.7 • Classification • Acute toxicity in range >1 - £10 mg/L (fish) • No data for rapid degradability, and log Kow <4 • No BCF or chronic toxicity data • Therefore assign: Acute II & Chronic II as assume not rapidly degradable in absence of data

  19. Variations on Substance X • Substance X – variation 4 • Fish LC50 no data; Daphnia EC50 20mg/L; Algae ErC50 82mg/L • Biodegradability <5% in OECD 301 • log Kow 2.7 • Classification • Acute toxicity in range >10 - £100 mg/L (Daphnia & Algae) • Not rapidly degradable (therefore log Kow <4 is not taken into account) • No BCF or chronic toxicity data • Therefore assign: Provisional Classification Acute III; Chronic III as classification based on data from 2, not 3 species

  20. Variations on Substance X • Substance X – variation 5 • Fish LC50, Daphnia EC50 and Algae ErC50 all above water solubility • Water solubility 50 mg/L • Biodegradability <5% in OECD 301 • log Kow 2.7 • Classification • Acute toxicity above water solubility • Not rapidly degradable, but log Kow <4 • No BCF or chronic toxicity data • Therefore assign: No Classification

  21. Variations on Substance X • Substance X – variation 6 • Fish LC50, Daphnia EC50 and Algae ErC50 all above water solubility • Water solubility >1 mg/L • Biodegradability <5% in OECD 301 • log Kow 2.7 • Classification • Considered poorly soluble & acute toxicity above water solubility • Not rapidly degradable, but log Kow <4 • No BCF or chronic toxicity data • Therefore assign: No Classification

  22. Variations on Substance X • Substance X – variation 7 • Fish LC50, Daphnia EC50 and Algae ErC50 all above water solubility • Water solubility <1 mg/L • Biodegradability <5% in OECD 301 • log Kow 5 • Classification • Considered poorly soluble & acute toxicity above water solubility • Not rapidly degradable and log Kow >4 • No BCF or chronic toxicity data • Therefore assign: Chronic IV

  23. GHS Classification of Mixtures

  24. GHS - Mixtures Options • Testing • Bridging • Calculation • Additivity • Summation (including M-factors) • Examples

  25. Hierarchy of Data Acceptability • Classification based on testing of mixture • Classification based on bridging principles • Classification based on calculation.

  26. Response (%) LC50 (Toxicity) Concentration (mg/l) Testing • GHS allows classification based on testing of mixtures but only for toxicity:

  27. Cfish Cwater % Theoretical CO2 produced (Biodegradation) (Bioconcentration) Time (days) Testing not allowed • Biodegradation and bioaccumulation are used to derive chronic classification classes. • Testing is not allowed for biodegradation and bioaccumulation. • So, chronic classification can only be assigned using bridging or calculation methods.

  28. 100 Response (%) LC50 0 1 10 100 Concentration of mixture (mg/l) Testing allowed • The toxicity of mixtures can be tested using the same methodology as used for single substances, setting up a range of concentrations to determine the LC50 or EC50, but there may be additional complications……..

  29. Testing Issues • Components with differing solubility: • undissolved components may cause physical interference (fouling), which is excluded from measures of toxicity. • WAF approach is the answer. • Confirmation of exposure concentrations: • May be impractical to monitor the concentration of all components. • Need for Best Professional Judgement as to what should be measured.

  30. Bridging • Provides for the situation in which the mixture has not been tested, but a similar mixture has been tested. ‘Similar’ can be defined in terms of: • Dilution • Batching • Concentration of Chronic I or Acute I components • Interpolation • Substantially similar mixtures

  31. = Bridging I - dilution + Mixture or Substance B (Classification known) Mixture of A+B (=C) (Not Tested) Mixture A (Tested)

  32. = A + B = C Bridging - dilution • If ‘B’ is water or is totally non-toxic, then classification of ‘C’ can be calculated • eg if LC50 of ‘A’ is 6 mg/l (Acute II), and it is diluted 2x with water, then toxicity of ‘C’ is estimated to be 12 mg/l (Acute III) • If ‘B’ is classified but has a hazard classification less than the least toxic component of ‘A’, then ‘C’ can be classified as for ‘A’. • eg if LC50 of ‘B’ is 15 mg/l (Acute III) and least toxic component of ‘A’ has an LC50 of 6 mg/l (Acute II), then ‘C’ can be classified as Acute II

  33. Bridging II - batching • The classification of two batches of product from one manufacturer is assumed to be the same……… ………….unless there is reason to believe that variation (in, for example, feedstock, manufacturing process) will have affected the classification.

  34. Bridging III - concentration • If a component causes a mixture to be classified as Acute I or Chronic I, and that component is concentrated, the new mixture will also be classified as Acute I or Chronic I.

  35. Bridging IV - interpolation • If Mixture C contains the same components as Mixtures A & B, in quantities intermediate between those in A & B….. ……. and if Mixtures A & B have the same classification….. …….then Mixture C will also have the same classification

  36. 30% 70% 90% 10% 60% 40% Mixture A Acute II Mixture B Acute II Mixture C Interpolate as Acute II Bridging – interpolation example

  37. Bridging V - substantially similar mixtures • If two mixtures differ in one component, but otherwise have the same composition…… …… and if the components that differ have the same classification…… …… then the two mixtures can be assumed to have the same classification. • Thus, if the toxicity of one of the mixtures has been tested and a classification derived, the classification of the second mixture can be assumed to be the same as that of the first.

  38. Component p, 10%Component j, 80% Component n,10% Component p, 10%Component j, 80% Component m,10% Bridging – substantially similar mixtures, example Mixture B Not tested If Component ‘m’ has the same classification as Component ‘n’, then Mixture B should be Acute II, as is Mixture A. If toxicity of ‘m’ and ‘n’ differs, bridging is not possible. Mixture A Tested - Acute II

  39. Calculations • Summation • Additivity

  40. Calculation – summation (acute) (all components toxicity > 0.1 mg/l)

  41. Calculation – summation (acute)(some components toxic at  0.1 mg/l) * M is a multiplying factor to take account of the toxic contribution of components toxic at 0.1 mg/l. It is calculated separately for each Acute I component.

  42. Calculation – summation, M-factor

  43. Summation example I (data) * All components are readily biodegradable and have log Kow<4

  44. Summation example I (acute analysis) • Apply summation to all components • No components toxic at 0.1 mg/l, so no M-factor to apply •  acute I components = 0, which is <25%, so acute I does not apply •  (10 x acute I) + acute II = 13%, which is <25%, so acute II does not apply. •  (100 x acute I) + (10 x acute II) + acute III=130%, which is >25%, so acute III applies.

  45. Calculation – summation (chronic)(some components toxic at  0.1 mg/l) * Same M-factor as for acute

  46. Summation example II (data)

  47. Summation example II (chronic analysis) • Apply summation to all components* • No components toxic at 0.1 mg/l, so no M-factor to apply •  chronic I components = 0, which is <25%, so chronic I does not apply •  (10 x chronic I) + chronic II = 13%, which is <25%, so chronic II does not apply. •  (100 x chronic I) + (10 x chronic II) + chronic III=130%, which is >25%, so chronic III applies. * Acute classification is ignored in this example

  48. Summation example III (data) n/r – not relevant to summation

  49. Summation Example III (acute and chronic analysis) Acute classification •  (M x acute I) = (100x0.009)+(1x4)=4.9, which is <25%, so acute I does not apply •  (10 x ( (M x acute I)) + acute II = (10 x 4.9)+5=54%, which is >25%, so acute II applies. • Since acute II applies, no need to analyse for acute III.

  50. Summation Example III (acute and chronic analysis) Chronic classification •  (M x chronic I) = 1x4=4, which is <25%, so chronic I does not apply •  (M x 10 x chronic I) + chronic II = 40%, which is >25%, so chronic II applies. • Since chronic II applies, no need to analyse for chronic III. Overall classification is acute II, chronic II

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