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Administrative data

Key value for chemical safety assessment

Additional information

The substance was evaluated for its mutagenic and genotoxic potential in-vitro. Overall the data do not indicate any mutagenic or genotoxic potential of the substance.

in-vitro-Tests:

No evidence for a mutagenic effect was obtained in Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A in experiments with and without microsomal activation.

No evidence for a clastogenic effect in Chinese Hamster ovary cells was obtained.

No induction of SCE's in Chinese Hamster ovary cells occured.

The studies were found to be adequate to fufill the purposes of this endpoint.


Short description of key information:
in-vitro: negative in Ames Test with Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A (with and without microsomal activation)
in-vitro: negative in Chromosome Aberration Test in Chinese Hamster ovary cells
in-vivo: negative in SCE-Assay in Chinese Hamster ovary cells

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the substance with regard to mutagenicity.

The substance is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008