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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
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:
1980

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

Constituent 1
Chemical structure
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

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 activation

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.
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.