Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ames Test:

No biologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method. A small, statistically significant increase in TA1537 revertant colony frequency was observed in the absence of S9-mix at 500 µg/plate in the range-finding test. This increase was considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant counts at 500 µg/plate were within the in-house historical untreated/vehicle control range for the tester strain and the fold increase was only 1.29 times the concurrent vehicle control.

The test item, Sodium sulphamate, was considered to be non-mutagenic under the conditions of this test.

Chromosome Aberration Test in Human Lymphocytes:

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:

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 test.

 



Short description of key information:
Three in-vitro studies were conducted on the substance:
- Reverse mutation assay 'Ames Test' using S. typhimurium and E. coli
- Chromosome aberration test in human lymphocytes
- CHO HPRT forward mutation assay.
All 3 studies gave negative results.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on negative results in the three following in-vitro studies, in substance is not classified for mutagencity.

- Reverse mutation assay 'Ames Test' using S. typhimurium and E. coli:

The test item, Sodium sulphamate, was considered to be non-mutagenic under the conditions of this test.

- Chromosome aberration test in human lymphocytes:

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:

The test item was considered to be non-mutagenic to CHO cells at the HPRT locus under the conditions of the test.