Registration Dossier
Registration Dossier
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EC number: 939-053-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Reverse gene mutation assay in bacteria
In a reverse gene mutation assay in bacteria according to OECD Guideline 471, the strains TA 1535, TA 97a, TA 98, TA 100 and TA 102 of S. typhimurium were exposed to Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid in the presence and absence of mammalian metabolic activation (rat liver S9-mix induced by Aroclor 1254).
Strains were exposed to the test item, diluted in water, at concentrations of 50, 150, 500, 1500 and 5000 µg / plate in the first experiments (1a and 1b) and to 313, 625, 1250, 2500 and 5000 µg/plate in the second experiments (2a and 2b). The first experiments were conducted using the plate incorporation method; in the second experiments the pre-incubation method was used.
In neither of the tests precipitation or signs of toxicity towards the bacteria were observed at any concentration.
There was no evidence of induced mutant colonies over background up to the limit concentration of 5000 µg/plate.
The positive controls induced the appropriate responses in the corresponding strains and activity of metabolic system was confirmed. Values for the spontaneous revertants of the negative controls were in the normal range.
This study satisfies the requirement for Test OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
The test item Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid, aqueous solution was considered as not mutagenic under the conditions of the test.
Justification for selection of genetic toxicity endpoint
The key study is GLP-compliant and of high quality (Klimisch 1).
Short description of key information:
In vitro data from a bacterial reverse mutation assay (Ames Test) are available for Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In conclusion, Reaction mass of 1,3-benzene disulfonic acid and sulfuric acid does not need to be classified for germ cell mutagenicity according to GHS Regulation EC No 1272/2008. No labelling is required.
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