Identify information requirements - SFT

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An example: Annex XI, 1.5; grouping and read-across • Note requirements of legal text, especially for “adequate and reliable documentation” • Standard for documentation is set out in the guidance • http://echa.europa.eu/documents/10162/17224/information_requirements_r6_en.pdf • Need to explain (provide a hypothesis) why, for a given endpoint the properties of the registered substance “may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (readacross approach).” • Chemical similarity is not necessarily sufficient to justify a read-across • Practical guide on read-across: http://echa.europa.eu/documents/10162/17250/pg_report_readacross_en.pdf Atelier REACH - Société Française de Toxicologie 28.09.2012 18
Annex XI, 3; Exposure-based adaptation • Only for endpoints in Annexes IX-X and • section 8.6 (repeated dose toxicity) and • Section 8.7 (reproductive toxicity) in Annex VIII • Needs exposure scenario(s) developed in the Chemical Safety Report • Documentation that the specific criteria are met Atelier REACH - Société Française de Toxicologie 28.09.2012 19
Page 1 and 2: Registration requirement under REAC
Page 3 and 4: Identify the information requiremen
Page 5 and 6: Identify information requirements (
Page 7 and 8: Step 1: Gather existing information
Page 9 and 10: Step 2: Information requirements
Page 11 and 12: Step 4: Generate new information
Page 13 and 14: Testing proposals • Required for
Page 15 and 16: Adaptations Atelier REACH - Sociét
Page 17: Adaptation - Annex XI, 1 • XI, 1.
Page 21: Thank you http://echa.europa.eu/

Identify information requirements - SFT

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