Case A-008-2022 concerns a substance evaluation decision on 5-amino-o-cresol requesting an in vivo mammalian alkaline comet assay (OECD TG 489). The request was based on a concern related to mutagenicity (chromosomal aberration and gene mutation).
The appellant’s arguments that ECHA committed errors in requesting information to clarify a concern related to gene mutation were rejected.
However, the Board of Appeal found that the Agency had failed to demonstrate that there is a potential risk related to chromosomal aberration. The contested decision was therefore annulled and the case remitted to ECHA for further action.