Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames assay: negative

Micronucleus assay: negative

Additional information

Bacterial reverse mutation assay, Ames test on similar substance 1 showed negative results for TA 1535, TA 1537, TA 98, TA 100 strains and E. coli WP2 uvrA strain with and without metabolic activation.

Moreover an in vitro ctyogenicity micronucleus test was performed in order to strenghten the outcome of the Ames test. Tthe results confirmed that similar substance 1 had no genotoxic effects in the human peripheral blood lymphocytes with as well as without metabolic activation.

Therefore, based on these results, the test item could be considered as not mutagenic.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), Annex I, Part 3, substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans are classified in Category 2. This classification is based on positive evidence obtained in:

— somatic cell mutagenicity tests in vivo, in mammals; or

— otherin vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

Note: substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens.

In vitro mutagenicity tests are the following:

in vitro mammalian chromosome aberration test;

in vitro mammalian cell gene mutation test;

— bacterial reverse mutation tests.

Based on currently available data, the assessment on the genotoxic potential of target substance is negative.