Registration Dossier
Registration Dossier
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EC number: 435-190-8 | CAS number: 246871-16-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
There are two in vitro studies conducted to assess the genetic potential of test item under the GLP principle, including Ames test and chromosome aberration test.
A study (RCC Study Number 764482) was conducted to assess the potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro in two independent experiments according to the current OECD Guideline 473. In both independent experiments, no biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No biologically relevant increase in the frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls. It can be stated that FAT 41'029/A did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line).
Also, the Ames test (RCC Study Number 756426), which was performed to investigate the potential of FAT 41030/A to induce gene mutations using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escheria coli strain WP2 uvrA, gave negative results. The assay was performed with and without liver microsomal activation. The test item was tested at the following concentrations:
33; 100; 333; 1000; 2500; and 5000 µg/plate
No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. No substantial increase in revertant colony was observed following treatment with FAT 41029/A at any dose level, neither in the presence nor absence of metabolic activation (S9 mix).
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce frameshift or base-pair mutations,with or without metabolic activation.
The Ames and chromosome aberration studies indicated the negative result Thus, it was concluded that the test substance indicates no genetic toxicity under the experiment condition.
Short description of key information:
In conclusion it can be stated that under the experimental conditions reported the test item did not induce mutagenic effects.
Endpoint Conclusion:
Justification for classification or non-classification
Based on the available results, test item caused no mutagenic potential. Therefore, it is not to be classified according to the CLP Regulation EC No. 1272/2008 or DSD (Directive 67/548/EEC).
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