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Administrative data

Key value for chemical safety assessment

Additional information

A study was performed to assess the mutagenic potential of the submission substance using a bacterial/microsome test system (Ames plate incorporation method). The method conforms to OECD Guideline 471. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of the test.

A study was conducted to assess the clastogenic potential of the submission substance using human lymphocytes. The substance did not induce any significant increases in the frequency of cells with aberrations in any of the treatment cases. The submission substance was shown to be non-toxic and non-clastogenic to human lymphocytes in-vitro in all four treatment cases.

A study was conducted to assess the potential mutagenicity of the submission substance to the thymidine kinase, TK +/-locaus of the L5178Y mouse lymphoma cell line. The test method used meets the requirements of OECD Guideline 476. The test material did not induce any statistically significant or dose-related increases in the mutant frequency at any of the dose levels, either with or without metabolic activation, in either the first or second experiment using a dose range where maximum exposure of the test material to the cells had been achieved.

The test material was considered to be non-mutagenic to L5178Y cells under the conditions of the test.

Reliability

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and were in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.


Short description of key information:
The submission substance was found to be non-mutagenic to bacterial cells in an Ames study, non-clastogenic to mammalian cells in a chromosome aberration study, and non-mutagenic to mammalian cells in a mouse lymphoma study.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The submission substance was found to be non-mutagenic to bacterial cells (Ames study), mammalian cells (mouse lymphoma assay), and non-clastogenic to mammalian cells (chromosome aberration study), so therefore does not meet the criteria required for classification.