ECHA Board of Appeal | 12 July 2022 | ARKEMA France S.A., France

Subject matter: A decision taken by the European Chemicals Agency (‘the Agency’) pursuant to Article 41 of the REACH Regulation

Background and remedy sought by the Appellants

On 13 April 2022, the Agency adopted the Contested Decision following the compliance check of the registration dossiers for the substance Octane-1,2-diol (EC No 214-254-7; the ‘Substance’). According to the Contested Decision, the Appellants are required to submit, by 19 July 2024, information on an extended one-generation reproductive toxicity study (‘EOGRTS’; Column 1 of Section 8.7.3. of Annex IX; test method: OECD TG 443) to be performed on rats, by oral route, with the following specifications:

- Ten weeks premating exposure duration for the parental (‘P0’) generation;

- The highest dose level in P0 animals must be determined based on clear evidence of an adverse effect on sexual function and fertility without severe suffering or deaths as specified in Appendix 1 of the Contested Decision, or follow the limit dose concept. The reporting of the study must provide the justification for the setting of the dose levels;

- Cohort 1A (Reproductive toxicity); and

- Cohort 1B (Reproductive toxicity) without extension to mate the Cohort 1B animals to produce the F2 generation.

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