Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The substance is considered to be non-mutagenic in the Salmonella typhimurium reverse mutation assay.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

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

Category 1: 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;

Category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

Based on Chapter R.7a (2015): Endpoint specific guidance, at the REACH Annex VII level, the absence of genotoxicity in a study on bacteria (Ames assay) allows to conclude that the substance is not genotoxic. Accordingly, the substance is not classified for genetic toxicity within the CLP Regulation (EC 1272/2008).