Registration Dossier
Registration Dossier
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EC number: 237-399-8 | CAS number: 13770-92-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test substance Calcium disulphamate was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay (BASF 2017). A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system. The substance was considered not mutagenic based on these results.
More in vitro genotoxicity tests (chromosome aberration test in human lymphocytes, mammalian cell gene mutation test) are available for the structurally closely similar substance sodium sulphamate. The results of these assays are also considered relevant and are evaluated together with the substance-specific Ames test described above in a weight of evidence approach:
Chromosome Aberration Test in Human Lymphocytes (Bohnenberger, 2011):
Either with or without metabolic activation, no clastogenicity was observed at the concentrations evaluated.
No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures.
In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce structural chromosomal aberrations in human lymphocytes in vitro.
Therefore, Sodium Sulphamate is considered to be non-clastogenic in this chromosome aberration test, when tested up to the highest required concentration.
CHO HPRT Forward Mutation Assay (Morris, 2011):
The test item demonstrated no significant increases in mutant frequency at any dose level, either with or without metabolic activation, in either the first or second experiment.
The test item was therefore considered to be non-mutagenic to CHO cells at the HPRT locus under the conditions of the tes
Additional information
Justification for classification or non-classification
Based on negative results in a substance-specific Ames assay and three reliable in vitro studies with the strucurally closely related read-across substance sodium sulphamate, classification for mutagenicity is not considered warranted.
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