Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Three different charges of Benzenemethanol, alpha-(chloromethyl)-3 -hydroxy-, (alphaR)- were tested for their mutagenic potential in OECD 471 guideline studies (in compliance with GLP), based on the ability to induce point mutation in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA98) and Escherichia coli (WP2 uvrA) in a reverse mutation assay (BASF 2014). Bacteria were exposed to 3.3 - 5 200 µg of charges of high purity per plate in a standard plate test in the presence and absence of a metabolizing system (rat liver S-9 mix). No precipitation of the test substance or bacteriotoxic effects were found with and without S9 mix. An increase in the number of his+ revertants was observed without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is mutagenic under these experimental conditions.

The third test was conducted with a charge of low purity. There were no relevant increases in his+ or trp+ revertants with or without the addiion of S9 mix. No precipitation of the test substance with and without S9 mix were observed but bacteriotoxic effects depending on the strain and test conditions from about 500 μg/plate onward.

Based on the results of the studies conducted with the charges of high purity it was finally concluded that the test substance is mutagenic under these experimental conditions.

Justification for selection of genetic toxicity endpoint
Three genetic toxicity in vitro studies are available. This study is adequate for covering this endpoint.

Short description of key information:
Benzenemethanol, alpha-(chloromethyl)-3-hydroxy-, (alphaR)- is considered to be mutagenic in the bacterial reverse mutation study (OECD 471, GLP).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Benzenemethanol, alpha-(chloromethyl)-3 -hydroxy-, (alphaR)- was mutagenic in the Ames test. No further data on genetic toxicity is available. Based on this classification for genetic toxicity is not possible in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.