Mutagenicity study: comet assay combined with micronucleus test

ECHA’s Member State Committee has clarified that it considers the combined comet assay (OECD TG 489) and micronucleus test (OECD TG 474) as one study. The committee agreed to request a combined study when:

  • concerns for both gene mutation and chromosomal aberration exist; and
  • no other in vivo genotoxicity data is available in the dossier.