Registration Dossier
Registration Dossier
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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Mutagenicity in bacterial test systems
The test substance Pigment Yellow 191 was evaluated for mutagenicity in the bacterial reverse mutation test (EU method B.13/14) in accordance with GLP. This study was conducted using five strains of Salmonella typhimurium bacteria (TA98, TA100, TA1535, TA1537 and TA1538) with and without metabolic activation. The test substance was not mutagenic up to the tested concentration of 5000 µg/plate.
In vivo mammalian erythrocyte micronucleus test
The test substance was tested for the assessment of cytogenetic damage in vivo, using laboratory rat (Wistar).
The test was performed according to the EU Method B.12, Mutagenicity – In vivo Mammalian Erythrocyte Micronucleus Test. The method is analogous to the OECD Test Guideline No. 474, Mammalian Erythrocyte Micronucleus Test.
The test substance was administered to animals by stomach tube in single dose. Three dose levels were chosen according to the results of pilot experiment - 500, 1000 and 2000 mg/kg of body weight. Two bone marrow sampling intervals were used - 24 and 48 hours after administration. The group of animals without administration and concurrent negative and positive controls were included.
The smears obtained from bone marrow were examined by light microscope. In any dose levels investigated the test substance did not cause a significant increase of count of immature erythrocytes with micronuclei in comparison with negative control group.
Justification for selection of genetic toxicity endpoint
No study was selected, since the conclusion is based on the following assays: Bacterial reverse mutation assay (Ames test) and in vivo mammalian erythrocyte micronucleus test.
Short description of key information:
Gene mutation (reverse mutation assay/Ames test): negative in all tested bacterial strains with and without
metabolic activation (EU B.13/14).
In vivo mammalian erythrocyte micronucleus test: negative, did not give rise to formation of micronuclei in immature erytrocytes in bone marrow of rat (EU B.12/OECD 474).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the results of in vitro bacterial gene mutation study and in vivo mammalian erythrocyte micronucleus test no classification is proposed for genotoxicity according to the criteria of CLP regulation 1272/2008 and the EU directive 67/548/EEC.
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