Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A bacterial reverse mutation assay (Ames test) has been undertaken using methods similar to or equivalent to OECD test methods. The substance does not induce reverse mutation in Salmonella typhimuriumi.

 

The ability to cause chromosomal damage in cultured human lymphocytes, followingi n vitro treatment in the absence and presence of S9 metabolic activation has been investigated according to OECD/EU test methods. No statistically significant increase in the incidence of cells bearing aberrations, including or excluding gaps, was observed at any dose level or any sampling time.

 

Mutagenic activity has been examined by assaying for the induction mutants in mouse lymphoma L5178Y cells after in vitro treatment, in the absence and presence of S9 metabolic activation, using a fluctuation method according to OECD/EU test methods. No relevant increases in mutant frequencies were observed following treatment.

 

Mutagenic activity has also been examined by the mouse Balb/3T3 cell transformation assay. No activity was apparent even at concentrations higher than the aqueous solubility of the substance.


Short description of key information:
Negative findings in the bacterial reverse mutation test, chromosome aberration test, gene mutation test using mouse lymphoma L5178Y cells and mouse Balb/3T3 cell transformation assay

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative findings in 3 separate and key in-vitro tests for gene mutation / mutagenicity. Supporting information from an additional in-vitro cell transformation assay.