ECHA Board of Appeal | 17 October 2022| Appeal on dossier evaluation / compliance check for di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide (CAS 78-63-7)

Background and remedy sought by the Appellants

On 8 June 2022, the Agency adopted the Contested Decision following the compliance check of the Appellants’ registration dossiers for  di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide (the Substance) 3 .

According to the Contested Decision, the Appellants are required to submit information on several studies, including 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 the oral route, with the following specifications:

– Ten weeks premating exposure duration for the parental (P0) generation;

– Dose level setting shall aim to induce systemic toxicity at the highest dose level;

– Cohort 1A (Reproductive toxicity);

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

– Cohorts 2A and 2B (Developmental neurotoxicity); and

– Investigations on learning and memory function as described in paragraph 37 of the OECD TG 426.

CONTINUE READING ON: echa.europa.eu