Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Chromosomal Abberation - study substance (with or without S9 metabolizing enzymes) is non-clastogenic to human lymphocytes in vitro (OECD TG 473) 


Gene Mutation - study substance (with or without S9 metabolizing enzymes) is non-mutagenic to V79 cells at the HPRT locus (OECD TG 476)


Reverse Mutation (Ames) - study substance (with or without S9 metabolizing enzymes) is non-mutagenic to TA1535, TA1537, TA98, TA100, and WP2uvrA (OECD TG 471) 

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

Additional information

Study substance is not genotoxic as assessed in multiple in vitro studies.  While these in vitro tests are not regarded as stand alone, they can be used together with other data in an overall Weight of Evidence assessment.


 

Justification for classification or non-classification

"Not Classified" according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.