Registration Dossier
Registration Dossier
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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Bacterial Reverse Mutation, Ames test
A bacterial reverse mutation test was conducted according to EU test method B13/14. Four mutant strains of Salmonella Typhimurium (TA1535, TA1537, TA1538, and TA100) were exposed to NC-4 (applied as a solution in Dimethylsulphoxide). Concentration levels were 2.5, 0.75, 0.25, 0.075, 0.025, and 0.5 mg/plate. The test was conducted with and without metabolic activation. No indication of mutagenic potential was seen at any concentration level, with or without metabolic activation, in any of the bacterial strains tested.
In-vitro gene mutation test, Mouse Lymphoma assay (Huntingdon Life Sciences, 2011)
An assay using Mouse Lymphoma L5178Y cells was conducted according to OECD test guideline 476 / EU test method B17, and in compliance with GLP. The test material was applied as a solution in DMSO; the test were conducted between 16.56 mg/mL and 1060 µg/mL with and without metabolic activation over 3 hours, and between 4.14 and 132.5 µg/mL without metabolic activation for 24 hours. The test material did not show signs of cytotoxicity and did not demonstrate any mutagenic potential under the experimental conditions.
In-vivo chromosome aberration / mouse micronucleus test
An in-vivo chromosome aberration (Mouse Micronucleus) test was conducted according to OECD test guideline 474. 30 mice (NMRI) per sacrifice time were dosed with the test material in olive oil at 5000 mg/kg by oral gavage. Test groups were sacrificed at 24, 48, or 72 hours after dosing.The test did not indicate any mutagenic potential for NC-4.
Short description of key information:
Bacterial reverse mutation (S. Typhimurium TA1535, TA1537, TA1538, and TA100): No mutagenic potential observed.
In-vitro gene mutation (mouse Lymphoma L5178Y): No mutagenic potential observed.
In-vivo chromosome aberration test (Mouse micronucleus): No mutagenic potential observed.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Of the three genetic toxicity tests conducted on NC-4 (two in-vitro, one in-vivo), none concluded mutagenic potential on the part of the test material. On this basis, classification of NC-4 as mutagenic is not justified.
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