Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

in vitro study on bacteria, OECD 471, with nitroreductasi deficient strains: negative
in vitro, gene mutation, OECD 476 -V79 cells, negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

in vivo, chromosome aberration, OECD 474 (micronucleus), negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:

- substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans or

- substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

According to the ECHA Guidance R7.a Table R.7.7-5, in the presence of a positive result in Gene Mutation on bacteria test, a negative result in the “Cytotoxicity in vitro” test and a negative result in “Gene mutation in vivo” test, the substance can be stated as non genotoxic.

Based on the above reported test results the test item is not classified for genetic toxicity according to the CLP Regulation (EC n. 1272/2008).