state of the art assessment of endocrine...
TRANSCRIPT
ANNEXES
STATE OF THE ART ASSESSMENT OF
ENDOCRINE DISRUPTERS
Final Report
Project Contract Number
070307/2009/550687/SER/D3
Annex 3
COMPARATIVE ANALYSIS OF ENDPOINTS AND
ASSAYS BY HUMAN HEALTH AND WILDLIFE
ENDPOINT
Authors: Olwenn Martin, Andreas Kortenkamp
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The results of the scientific summary (Annex1), the OECD Conceptual Framework Guidance
Document, the Detailed Review Paper on Novel Endpoint and Assays as well as current testing
requirements for REACH and the PPPR were analysed by assay endpoint for each human health or
wildlife endpoint. The results were compiled in an excel spreadsheet submitted electronically and
presented in this annex as a series of tables.
Table 1. Male Reproductive Health - Summary of scientific results of regulatory relevance ................ 5
Table 2. Male Reproductive Health – OECD Conceptual Framework ..................................................... 6
Table 3. Male Reproductive Health – Current Regulatory Testing Requirements under REACH and
PPPR ........................................................................................................................................................ 7
Table 4. Female Reproductive Health, precocious puberty - Summary of scientific results of
regulatory relevance ............................................................................................................................... 9
Table 5. Female Reproductive Health, precocious puberty – OECD Conceptual Framework .............. 10
Table 6. Female Reproductive Health, precocious puberty – Current Regulatory Testing
Requirements under REACH and PPPR ................................................................................................. 11
Table 7. Female Reproductive Health, Fecundity – Summary of scientific results of regulatory
relevance ............................................................................................................................................... 12
Table 8. Female Reproductive Health, Fecundity – OECD Conceptual Framework.............................. 13
Table 9. Female Reproductive Health, Fecundity - Current Regulatory Testing Requirements under
REACH and PPPR ................................................................................................................................... 14
Table 10. Female Reproductive Health, PCOS – Summary of scientific results of regulatory relevance
.............................................................................................................................................................. 15
Table 11. Female Reproductive Health, PCOS – OECD Conceptual Framework ................................... 16
Table 12. Female Reproductive Health, PCOS – Current Regulatory Testing Requirements under
REACH and PPPR ................................................................................................................................... 17
Table 13. Female Reproductive Health, Pregnancy Outcomes – Summary of scientific results of
regulatory relevance ............................................................................................................................. 18
Table 14. Female Reproductive Health, Pregnancy Outcomes – OECD Conceptual Framework ......... 20
Table 15. Female Reproductive Health, Pregnancy Outcomes - Current Regulatory Testing
Requirements under REACH and PPPR ................................................................................................. 22
Table 16. Female Reproductive Health, Endometriosis and Uterine Fibroids – Summary of scientific
results of regulatory relevance ............................................................................................................. 24
Table 17. Female Reproductive Health, Endometriosis and Uterine Fibroids – OECD Conceptual
Framework ............................................................................................................................................ 25
Table 18. Female Reproductive Health, Endometriosis and Uterine Fibroids – Current Regulatory
Testing Requirements under REACH and PPPR .................................................................................... 26
Table 19. Hormonal Cancers – Summary Results of Regulatory Significance....................................... 28
Table 20. Hormonal Cancers – OECD Conceptual Framework ............................................................. 30
Table 21. Hormonal Cancers - Current Regulatory Testing Requirements under REACH and PPPR .... 32
Table 22. Developmental Neurotoxicity – Summary of scientific results of regulatory relevance ...... 35
Table 23. Developmental Neurotoxicity – OECD Conceptual Framework ............................................ 39
Table 24. Developmental neurotoxicity - Current Regulatory Testing Requirements under REACH and
PPPR ...................................................................................................................................................... 43
Table 25. Metabolic syndrome – Summary of scientific results of regulatory relevance .................... 48
Table 26. Metabolic Syndrome – OECD Conceptual Framework ......................................................... 49
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Table 27. Metabolic Syndrome - Current Regulatory Testing Requirements under REACH and PPPR 50
Table 28. Invertebrates, Reproduction – Summary of scientific results of regulatory importance ..... 52
Table 29. Invertebrates, Reproduction – OECD Conceptual Framework ............................................. 53
Table 30. Invertebrates, Reproduction – Current regulatory testing requirements under REACH and
PPPR ...................................................................................................................................................... 54
Table 31. Invertebrates, Growth and development & Behaviour – Summary of scientific results of
regulatory relevance ............................................................................................................................. 55
Table 32. Invertebrates, Growth and development & Behaviour – OECD Conceptual Framework ..... 56
Table 33. Invertebrates, Reproduction – Current regulatory testing requirements under REACH and
the PPPR ................................................................................................................................................ 57
Table 34. Fish, Reproduction – Summary of scientific results of regulatory relevance ....................... 59
Table 35. Fish, Reproduction – OECD Conceptual Framework ............................................................. 60
Table 36. Fish, Reproduction – Current regulatory testing requirement under REACH and PPPR ...... 61
Table 37. Fish, Growth and Development & Behaviour – Summary of scientific results of regulatory
relevance ............................................................................................................................................... 62
Table 38. Fish, Growth and development & Behaviour – OECD Conceptual Framework .................... 63
Table 39. Fish, Growth and development & Behaviour – Current regulatory requirements under
REACH and PPPR ................................................................................................................................... 64
Table 40. Amphibians and reptiles – Summary of scientific results of regulatory relevance ............... 66
Table 41. Amphibians and reptiles – OECD Conceptual Framework .................................................... 67
Table 42. Amphibians and reptiles – Current regulatory testing requirements under PPPR and REACH
.............................................................................................................................................................. 68
Table 43. Birds, reproduction – Summary of scientific results of regulatory relevance....................... 70
Table 44. Birds, reproduction – OECD Conceptual Framework ............................................................ 71
Table 45. Birds, reproduction – Current regulatory testing requirements under REACH and PPPR .... 72
Table 46. Birds, Growth and development & Behaviour – Summary of scientific results of regulatory
relevance ............................................................................................................................................... 73
Table 47. Birds, Growth and development & Behaviour – OECD Conceptual Framework .................. 74
Table 48. Birds, Growth and development & Behaviour – Current regulatory testing requirements
under REACH and PPPR ......................................................................................................................... 75
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1 HUMAN HEALTH ENDPOINTS
1.1 MALE REPRODUCTIVE HEALTH
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Table 1. Male Reproductive Health - Summary of scientific results of regulatory relevance
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Table 2. Male Reproductive Health – OECD Conceptual Framework
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Table 3. Male Reproductive Health – Current Regulatory Testing Requirements under REACH and PPPR
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1.2 FEMALE REPRODUCTIVE HEALTH
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Table 4. Female Reproductive Health, precocious puberty - Summary of scientific results of regulatory relevance
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Table 5. Female Reproductive Health, precocious puberty – OECD Conceptual Framework
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Table 6. Female Reproductive Health, precocious puberty – Current Regulatory Testing Requirements under REACH and PPPR
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Table 7. Female Reproductive Health, Fecundity – Summary of scientific results of regulatory relevance
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Table 8. Female Reproductive Health, Fecundity – OECD Conceptual Framework
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Table 9. Female Reproductive Health, Fecundity - Current Regulatory Testing Requirements under REACH and PPPR
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Table 10. Female Reproductive Health, PCOS – Summary of scientific results of regulatory relevance
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Table 11. Female Reproductive Health, PCOS – OECD Conceptual Framework
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Table 12. Female Reproductive Health, PCOS – Current Regulatory Testing Requirements under REACH and PPPR
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Table 13. Female Reproductive Health, Pregnancy Outcomes – Summary of scientific results of regulatory relevance
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Table 14. Female Reproductive Health, Pregnancy Outcomes – OECD Conceptual Framework
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Table 15. Female Reproductive Health, Pregnancy Outcomes - Current Regulatory Testing Requirements under REACH and PPPR
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Table 16. Female Reproductive Health, Endometriosis and Uterine Fibroids – Summary of scientific results of regulatory relevance
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Table 17. Female Reproductive Health, Endometriosis and Uterine Fibroids – OECD Conceptual Framework
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Table 18. Female Reproductive Health, Endometriosis and Uterine Fibroids – Current Regulatory Testing Requirements under REACH and PPPR
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1.3 HORMONAL CANCERS
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Table 19. Hormonal Cancers – Summary Results of Regulatory Significance
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Table 20. Hormonal Cancers – OECD Conceptual Framework
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Table 21. Hormonal Cancers - Current Regulatory Testing Requirements under REACH and PPPR
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1.4 DEVELOPMENTAL NEUROTOXICITY
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Table 22. Developmental Neurotoxicity – Summary of scientific results of regulatory relevance
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Table 23. Developmental Neurotoxicity – OECD Conceptual Framework
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Table 24. Developmental neurotoxicity - Current Regulatory Testing Requirements under REACH and PPPR
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1.5 METABOLIC SYNDROME
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Table 25. Metabolic syndrome – Summary of scientific results of regulatory relevance
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Table 26. Metabolic Syndrome – OECD Conceptual Framework
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Table 27. Metabolic Syndrome - Current Regulatory Testing Requirements under REACH and PPPR
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2 WILDLIFE ENDPOINTS
2.1 INVERTEBRATES
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Table 28. Invertebrates, Reproduction – Summary of scientific results of regulatory importance
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Table 29. Invertebrates, Reproduction – OECD Conceptual Framework
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Table 30. Invertebrates, Reproduction – Current regulatory testing requirements under REACH and PPPR
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Table 31. Invertebrates, Growth and development & Behaviour – Summary of scientific results of regulatory relevance
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Table 32. Invertebrates, Growth and development & Behaviour – OECD Conceptual Framework
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Table 33. Invertebrates, Reproduction – Current regulatory testing requirements under REACH and the PPPR
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2.2 FISH
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Table 34. Fish, Reproduction – Summary of scientific results of regulatory relevance
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Table 35. Fish, Reproduction – OECD Conceptual Framework
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Table 36. Fish, Reproduction – Current regulatory testing requirement under REACH and PPPR
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Table 37. Fish, Growth and Development & Behaviour – Summary of scientific results of regulatory relevance
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Table 38. Fish, Growth and development & Behaviour – OECD Conceptual Framework
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Table 39. Fish, Growth and development & Behaviour – Current regulatory requirements under REACH and PPPR
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2.3 AMPHIBIANS AND REPTILES
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Table 40. Amphibians and reptiles – Summary of scientific results of regulatory relevance
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Table 41. Amphibians and reptiles – OECD Conceptual Framework
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Table 42. Amphibians and reptiles – Current regulatory testing requirements under PPPR and REACH
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2.4 BIRDS
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Table 43. Birds, reproduction – Summary of scientific results of regulatory relevance
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Table 44. Birds, reproduction – OECD Conceptual Framework
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Table 45. Birds, reproduction – Current regulatory testing requirements under REACH and PPPR
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Table 46. Birds, Growth and development & Behaviour – Summary of scientific results of regulatory relevance
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Table 47. Birds, Growth and development & Behaviour – OECD Conceptual Framework
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Table 48. Birds, Growth and development & Behaviour – Current regulatory testing requirements under REACH and PPPR