Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro data

Bacterial gene mutation:

The potential of the test material to cause gene mutation in bacterial strains was determined in two studies which followed a methodology equivalent to standardised guideline OECD 471. During the studies five strains of Salmonella typhimurium (TA1535, TA1537, TA1538, TA98 and TA100) were treated in the presence and absence of at rat liver derived metabolic activation system (S9 mix). Under the conditions of both studies, the test material did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the tester strains used either in the presence or absence of metabolic activation. No toxicity was observed. The tester strains responded to the positive controls, known mutagens, as expected, confirming the validity of the test method employed.


Short description of key information:
IN VITRO DATA
Gene mutation in mammalian cells: Negative, OECD 471, Machado et al. (1981) & Machado and Carver (1982)

Endpoint Conclusion:

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for genetic toxicity based on the overall negative response noted in the available genetic toxicity studies.