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EC number: 402-480-0 | CAS number: 111850-26-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity in vitro:
In two independent GLP compliant Ames tests, performed according to OECD guideline 471, 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) were used to test the mutagenic potential of the test substance (20, 80, 320, 1280 and 5120 µg/plate), both with and without metabolic activation system (Battelle 1987). The test substance did not show any mutagenic activity in any strain.
No studies on the mutagenicity in mammalian cells of FAT40279 were available. However, a HPRT gene mutation test is available for the structural analogue FAT 40227.
In a GLP-compliant mammalian cell gene mutation assay, tested according to OECD guideline 476, Chinese hamster V79 cells were exposed to FAT 40227 with and without metabolic activation and the potential to induce mutations at the HPRT locus was assessed (BSL Bioservice 2013). The selection of the concentrations was based on data from the pre-experiments. Experiment I with and without metabolic activation and experiment II with metabolic activation were performed as a 4h short-term exposure assay. Experiment II without metabolic activation was performed as 20h long time exposure assay. The following concentrations were used. Experiment I without metabolic activation: 10, 25, 50, 100, 200, 400, 600, 800, 1000 and 1200µg/mL; Experiment I with metabolic activation: 1.0, 2.5, 5, 10, 25, 50, 100, and 125µg/mL; Experiment II without metabolic activation: 5, 10, 25, 50, 100, 250, 500, 1000, and 2000µg/mL; Experiment II with metabolic activation: 1.0, 3.16, 10, 20, 40, 60, 80, 100 and 120µg/mL. No precipitation was noted in the experiments. Biologically relevant growth inhibition was observed in experiment I and II with and without metabolic activation. In experiment I without metabolic activation the relative growth was 14.0% for the highest concentration (1200 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 125 µg/mL with a relative growth of 14.3%. In experiment II without metabolic activation the relative growth was 13.9% for the highest concentration (2000 µg/mL) evaluated. The highest concentration evaluated with metabolic activation was 120µg/mL with a relative growth of 10.6%. In both experiments no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). No dose-response relationship was observed. The positive controls showed distinct biologically relevant effects in mutation frequency. In conclusion, the test substance is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chines hamster.
Genetic toxicity in vivo:
In a GLP-compliant micronucleus test, tested according to OECD guideline 474, 5 non-consanguinous OF-1 albino mice originating from a SPF colony per sex per treatment group were treated once by oral gavage with the test substance 5000 mg/kg bw dissolved in distilled water followed by a 20, 44, 68 hour post exposure period. In a preliminary range finding study the concentration of 5000 mg/kg bw was chosen for the main-test. A positive control (Thio-TEPA) administered at a concentrationof 20 mg/kg bw showed pronounced evidence of mutagenicity 44 h after administration.
No mutagenic effect was observed in bone marrow smears taken 20, 44 and 68 h after administration of the test substance.
Short description of key information:
The test substance does not show any genetic toxicity in vitro (Ames test) and in vivo (Erythrocyte micronucleus test). The is substance is also considered to be non-mutagenic in the HPRT mutation assay with a structural analogue.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available genotoxicity studies, the test substance does not need to be classified for genotoxicity according to the Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008
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