Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Two studies were performed to assess the mutagenic potential of the submission substance using One of them isplate incorporation method. 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 substance was found to be non-mutagenic under the conditions of the test.The other study is conducted using the L5178Y mouse lymphoma cell line. 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. Therefore the substance was considered to be non-mutagenic to L5178Y mouse cells under the conditions of the test.

 Clastogenic potential of the substance was assessed using human lymphocytes Cells. The substance did not induce any significant increases in the frequency of cells with aberrations in any of the treatment conditions. The substance was shown to be non-clastogenic to human lymphocytes in vitro in all treatment cases.

All three genotoxicity tests described above meet the requirements of OECD Test Guidelines and are assigned to be reliability 1 data according to the scoring system of Klimisch et al (Klimisch et al., 1997). This ranking was deemed appropriate because the studies were conducted the GLP certified laboratory 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 in both Ames study and in mouse lymphoma study , and non-clastogenic to chromosome aberration study in human lymphocyte cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The submission substance was found to be non-mutagenic in both bacterial cells and mammalian (rodent) cells, and non-clastogenic to mammalian (human) cells. Therefore the substance does not meet the criteria required for classification of carcinogenicity.