Registration Dossier
Registration Dossier
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EC number: 942-467-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames test:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 (1997) and according to GLP principles. The test was performed in two independent experiments, both in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in all strains. Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in strain WP2uvrA , both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Chromosome aberration test:
In a chromosome aberration study, cultured peripheral human lymphocytes were exposed to different concentrations of the substance (dissolved in ethanol), in the presence and absence of S9-mix according to OECD 473 guideline and GLP principles. In the first cytogenetic assay, the substance
was tested up to cytotoxic concentrations of 70 and 100μg/mLfor a 3 h exposure time with a 24 h fixation time in the absence and presence of S9 -mix, respectively.
In the second cytogenetic assay, the substance was tested up to the cytotoxic concentration of 45μg/mLfor a 24 h exposure time with a 24 h fixationtime and up to the cytotoxic concentration of 50μg/mLfor a 48 h exposure time with a 48 h fixation time in the absence of S9 -mix.
In the presence of S9 -mix, the substance was tested up to the cytotoxic concentration of 130μg/mLfor a 3 h exposure time with a 48 h fixation time.
The substance did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments. No effects of the substance on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that the substance does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations nor polyploidy.Finally, it is concluded that the substance is not clastogenic in human lymphocytes.Justification for selection of genetic toxicity endpoint
The results of the bacterial and chromosomal genotoxicity assays are reliable and adequate for covering this endpoint.
Short description of key information:
Ames test (OECD TG 471): negative
In vitro chromosome aberration test (OECD TG 473): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of the genotixicity assays, FRET 09 -0536 does not have to be classified for genotoxicity in accordance with Regulation (EC) No. 1272/2008.
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