Registration Dossier
Registration Dossier
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EC number: 401-620-8 | CAS number: 87731-18-8 VIOLIFF
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The substance is negative in the Ames test (OECD TG 471).
The substance is not mutagenic (OECD TG 490).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
The substance is negative in the micronucleus test (OECD TG 474).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The bacterial reverse mutation (Ames) study
The substance is tested in the Ames test (OECD TG 471), using Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 and E. coli strain WP2uvrA. The test was performed in a direct plate assay up to 1500 µg/plate due to cytotoxicity in the preliminary test, both in the absence and presence of S9-mix. 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 tester strain WP2uvrA, both in the absence and presence of S9-metabolic activation. These results were confirmed in two independently repeated experiments for TA1537 and in one repeated experiment for all other strains. Based on these results, the substance is not mutagenic in the Ames test.
In vitro mouse lymphoma assay
The substance is tested in the in vitro mouse lymphoma assay (OECD TG 490) and following GLP. In the first experiment (3 hour treatment), the test item was tested up to concentrations of 220 μg/mL and 325 μg/mL in the absence and presence of S9-mix, respectively. In the second experiment (24 hour treatment), the test item was tested up to concentrations of 180 μg/mL in the absence of S9-mix. Reliable negative and positive control results showed that the test conditions functioned properly. Cytotoxicity was seen in agreement with the respective guideline. There were no positive results in L5178Y mouse lymphoma cells. Based on this observation the substance is not mutagenic in this test.
In vivo micronucleus test
The substance was tested in the in vivo micronucleus test (OECD TG 474). After a preliminary test to determine test concentrations, male and female mice were dosed with 2850 mg/kg. Three sampling times (24, 48 and 72 hours) were used. No animals died after treatment. The substance did not cause any substantial increases in the incidence of micronucleated normochromatic or polychromatic erythrocytes. The substance only caused slight but statistically significant decreases in the ratio of polychromatic to normochromatic erythrocytes at the 48 h sampling times suggesting that the substance has a cytotoxic activity towards bone marrow. Based on the results, the substance is not clastogenic in this test.
Justification for classification or non-classification
Based on the results of the gene mutations in bacterial cells (OECD 471) and mammalian cells (OECD 490) and cytogenicity information (Mammalian Erythrocyte Micronucleus Test: OECD 474) the substance is not genotoxic and therefore does not have to be classified for genotoxicity in accordance with EU CLP (EC no. 1272/2008 and its amendments).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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