Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Based on a GLP-study acc. to OECD guideline 471, in which no substantial increase in revertant colony numbers of any tester strain at any concentration were observed, the test item is considered as non-mutagenic in the bacterial reverse mutation assay.

In a GLP-Study according to OECD guideline no. 473, the test item did not induce structural chromosome aberration in V79 cells and is therefore considered negative.

In a GLP-Study according to OECD guideline no. 476, the test substance did not increase the mutation frequency (HPRT locus) in V79 cells and is therefore considered negative.


Short description of key information:
Genetic toxicity: bacterial reverse mutation assay (GLP, OECD 471) (Ames test): S. typhimurium TA 1535, TA 1537, TA 98 and TA 100: negative with and without metabolic activation: E. coli WP2 uvr A: negative with and without metabolic activation

Genetic toxicity: chromosome aberration in chinese hamster lung fibroblasts (V79) (GLP, OECD 473): negative with and without metabolic activation

Genetic toxicity: mammalian cell gene mutation assay (GLP, OECD 476): test cells: chinese hamster lung fibroblasts (V79): target gene HPRT: negative with and without metabolic activation

As a consequence, no distinct chemical safety assessment, including exposure determination and risk characterisation, has to be performed in accordance with article 14(4) of the REACH regulation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Since neither any classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) nor any criteria according to DSD (Directive 67/548/EEC) are fulfilled, the substance is not classified for genetic toxicity.