Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

6-tert-butyl-m-cresol shall be registrated according REACH Article 18 (transported isolated intermediate). Therefore only an in vitro gene mutation study in bacteria is necessary to fulfill the obligations according REACH Article 18, Annex VII. Further testing is is not necessary because to test result was negative.

Nevertheless additional results from other gentox assays were available or cited in the OECD SIDS Initial Assessment Report for 6 -tert-butyl-m-cresol. A chromosomal aberration test in CHL/IU cells (OECD TG 473) was positive for short-term treatment with an exogeneous metabolic activation system. However, a mouse micronucleus assay in vivo (OECD TG 474) was negative.

Short description of key information:
a valid Ames test with Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Echerichia coli according OECD TG 471/472 is available. 6-tert-butyl-m-cresol was not genotoxic in this test, with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Considering the negative result from the Ames test- the only test necessary to fulfill the obligations according REACH Article 18, Annex VII no classification in necessary.

The negative result of the in vivo micronucleus test seems more significant than the positive rest of the in vitro chromosome aberration test which is only positive with an exogeneous activation system.