Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Three in vitro mutagenicity studies have been conducted, evaluating gene mutation in bacterial cells, chromsome aberrations, and gene mutation in mammalian cells; two had read-across data from a similar structure. All three tests gave clear negative results both in the presence and absence of metabolic activation, indicating that the substance may be considered as non-mutagenic.


Short description of key information:
An Ames test in four strains of S. typhimurium and one strain of E. coli has been conducted in compliance with GLP according to OECD guideline 471, EU Method 13/14, and US EPA harmonised guidelines (Klimisch score of 1). Duplicate experiments were conducted. This study was negative with and without metabolic activation.

Read across data from a structurally similar compound from an in vitro chromosome aberration study with primary human lymphocytes has been conducted in compliance with GLP and according to EU Method B.10 (Klimisch score of 1 downgraded to 2 because of read-across). The substance did not induce chromosome aberrations in the presence or absence of metabolic activation.

Read across data from a structurally similar compound from a gene mutation assay with Chinese hamster V79 lung fibroblasts has been in conducted in compliance with GLP according EU Method B.17 (Klimisch score of 1 downgraded to 2 because of read-across). It was concluded that the substance was not mutagenic under the assay conditions with and without metabolic activation at all concentrations tested.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All three in vitro studies, investigating all three endpoints (i.e. gene mutation in bacterial cells, chromosome aberration, and gene mutation in mammalian cells) gave a clear negative result. There are no reasonable grounds for concern, hence there is no need to classify the substance as mutagenic.