Registration Dossier
Registration Dossier
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Reaction mass of tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate] and tetrasodium 4-[[1-hydroxy-6-[[[[5-hydroxy-6-[(2-methyl-4-sulphonatophenyl)azo]-7-sulphonato-2-naphthyl]amino]carbonyl]amino]-3-sulphonato-2-naphthyl]azo]benzoate and tetrasodium 4,4'-[carbonylbis[imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]dibenzoate
EC number: 942-930-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity in vitro
The substance to be registered was tested at a concentration of 75% for its mutagenic potential, in an OECD 471 guideline study, based on the ability to induce point mutation in selected loci of several bacterial strains of Salmonella typhimurium (TA 1535, TA 1537, TA 1538 TA98, TA100) in a reverse mutation assay. No cytotoxicity was observed. An increase in the number of his+ revertants was not observed in the standard plate test either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.
A mouse lymphoma assay was performed with analogue substance 1 (please refer to IUCLID section 13).
The structural analogue was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y. In the first experiment, cells were exposed to 10, 50, 100, 200, 400, 600, 1800 and 5000 µg/mL with and without metabolic activation. In the second experiment, cells were exposed to 30, 70, 150, 350, 700, 2100, 3600 and 5000 µg/mL with metabolic activation and to 10, 20, 50, 100, 200, 600, 1200 and 2500 µg/mL without metabolic activation. Growth inhibition was observed without metabolic activation. No mutagenic effects were observed without metabolic activation or with metabolic activation. It was therefore concluded that the test substance is not mutagenic under these experimental conditions. Furthermore, colony sizing showed no clastogenic effects induced by the test item under the experimental conditions.
Short description of key information:
The test substance was tested in a reverse mutation assay, and a structural analogue was tested in a mouse lymphoma assay (covering both mutagenic and clastogenic effects in mammalian cells). In both tests no genotoxicity was observed.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available in vitro genotoxicity tests with the registered substance itself and a structural analogue, classification for genotoxicity is not warranted according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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