Registration Dossier
Registration Dossier
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EC number: 611-084-9 | CAS number: 54041-17-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutation assay (Ames test):
FOE 5043-Hydroxy was investigated in a Salmonella/microsome test for point mutagenic effects in doses up to 5000 ng per tube after preincubation for 20 minutes at 37°C on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98. Doses up to and including 40 ng per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had only a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes. Evidence of mutagenic activity of FOE 5043-Hydroxy was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
In silico Ames Test:
No alert on mutagenicty when using state-of the-art prediction models (DEREK, Leadscope, VITIC) [Analysis March 18, 2021]
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In addition to the experimental Ames test an in silico prediction of genotoxicity was performed for assessing the possible DNA reactivity of the substance.
With regard to the results of the prediction models (DEREK, Leadscope, VITIC) the substance did not raise a concern with respect to possible mutagenicity [March 18, 2021].
| Derek Version: Derek Nexus: 6.1.0, Nexus: 2.3.0, Derek KB 2020 1.0 | ||
| Leadscope Version: 3.0.0-30, ICH-M7: Bacterial Mutation v2 | ||
| VITIC Version: 2.6.1 | ||
Justification for classification or non-classification
Based on the bacterial mutation test (Ames test) results in silico and in vitro no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
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