Registration Dossier
Registration Dossier
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EC number: 231-959-5 | CAS number: 7782-50-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Deficiencies: Yes.Only two strains were tested, a number of important information are missing (e.g. concentration of the test substance, incubation time, cytotoxicity, metabolic activation system, negative controls etc.).However, based on the other Ames tests it can be concluded that the test material is not positive in the reverse mutation assay in bacteria.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Principles of method if other than guideline:
- only two strains were used, cytotoxicity not determined, no controls, concentrations not stated
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium hypochlorite
- EC Number:
- 231-668-3
- EC Name:
- Sodium hypochlorite
- Cas Number:
- 7681-52-9
- Molecular formula:
- ClO.Na
- IUPAC Name:
- sodium hypochlorite
- Details on test material:
- Sodium hypochlorite
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA100, TA98
- Metabolic activation:
- with
- Metabolic activation system:
- not reported
- Test concentrations with justification for top dose:
- unspecified
- Details on test system and experimental conditions:
- Ames test
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- With S9-mix there were 35 revertant colonies per mg in the TA100 strain.
- Remarks on result:
- other: strain/cell type: S. typhimurium TA100
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):positive with metabolic activationThere was no increased incidence of revertant colonies without metabolic activation in both strains and with metabolic activation in the TA98 strain.With S9-mix there were 35 revertant colonies per mg in the TA100 strain. Positive (+S9-mix) only at TA100 with metabolic activation.
- Executive summary:
- MATERIALS AND METHODS:
Among 185 other compounds sodium hypochlorite was tested for mutagenicity in the Ames test with and without metabolic activation. The Salmonella typhimurium strains used were TA100 and TA 98. The number of revertants were counted.
RESULTS AND DISCUSSION:
There was no increased incidence of revertant colonies without metabolic activation in both strains and with metabolic activation in the TA98 strain. With S9-mix there were 35 revertant colonies per mg in the TA100 strain.
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