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3 Genetic Toxicity studies were conducted with and without activation according to the guidelines noted above. In all cases, no evidence of mutagenic activity was seen. Control materials induced the appropriate responses in all tests so the tests are considered valid.

 

The Mammalian Cell Gene Mutation study used Mouse Lymphoma L5178Y cells and was tested at concentrations up to 4140 micrograms/ml in acetone.

 

The Bacterial Mutation Assay used S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and WP2 uvrA at concentrations up to 5000 micrograms per plate. The number of revertants did not increase more than double of the solvent control value.

 

The Chromosome Aberration Study used CHL/IU cells and was tested at a concentration up to 5000 micrograms/ml.  There were no increases in structural aberrations or numerical aberrations greater than 5%.


Short description of key information:
Bacterial Reverse Mutation Assay: Non-mutagenic when tested according to Japanese Guideline for Screening Mutagenicity Testing of Compounds

Chromosome Aberration: Negative when tested according to OECD 473

Mammalian Cell Gene Mutation: Negative when tested according to OECD 476

Endpoint Conclusion:

Justification for classification or non-classification