ECHA Board of Appeal decision on case "Nouryon Functional Chemicals B.V., the Netherlands ARKEMA GmbH, Germany PERGAN Hilfsstoffe für industrielle Prozesse GmbH, Germany United Initiators GmbH, Germany"

Contested Decision :Decision of 8 June 2022 on a compliance check of the registration for the substance di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide, adopted by the European Chemicals Agency pursuant to Article 41 of the REACH Regulation

Decision

Summary of the facts

1. On 8 September 2022, the Appellants filed their appeal against the Contested Decision. The Appellants seek the annulment of the Contested Decision insofar as it requests information on an extended one-generation reproductive toxicity study (OECD test guideline 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