Registration Dossier
Registration Dossier
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EC number: 944-405-9 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames test:
The mutagenic activity of the substance IFF TM FRET 13 -0156 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, except in strain WP2uvrA. 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.
Micronucleu assay:
In a micronucleus assay, cultured peripheral human lymphocytes were exposed to different concentrations of the substance (dissolved in DMSO), in the presence and absence of S9-mix according to OECD 487 guideline and GLP principles.
The percentage of cells with micronuclei in the test article-treated group was not significantly increased relative to vehicle control at any dose level (p > 0.05, Fisher's Exact test) in the S9-activated 4-hour exposure group or the non-activated 24-hour exposure group. statistically increased but no dose-response relationship in three differetn treatment conditions.The percentage of cells with micronucleated binucleated cells in the non-activated 4-hour exposure group was statistically significantly increased relative to vehicle control at 800 μg/mL (p ≤ 0.05, Fisher’s Exact test) (the highest dose analyzed for mucronucleus was 1200 ug/ml). However, the Cochran-armitage test was negative for a dose response. In addition, the percentage of micronucleated binucleated cells in the test article-treated group (0.4%) was within the historical solvent control range of 0.1% to 1.6%. Therefore, the statistically significant increase was not considered to be biologically relevant.
The results for the positive and vehicle controls indicate that all criteria for a valid assay were met. Based on these criteria, the results are justified and do not require a repeat of any portions of the study.
Therefore FRET 13-0156 was concluded to be negative for the induction of micronuclei in the non-activated and S9-activated test systems in the in vitro mammalian micronucleus test using human peripheral blood lymphocytes.
Justification for selection of genetic toxicity endpoint
The results of the bacterial and micronucleus 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 487): negative
Endpoint Conclusion:No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of the genotixicity assays, IFF TM 13 -0156 does not have to be classified for genotoxicity in accordance with Regulation (EC) No. 1272/2008.
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