Registration Dossier

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: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (Ames)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Target gene:
histidine
Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20 - 5120 μg/plate
Concentration range in the main test (without metabolic activation): 20 - 5120 μg/plate
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: ≥ 320 μg/plate

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
> 5000 μg/plate
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Observations:
No increase in mutation rate was seen with the test substance in two independent experiments. Positive controls gave a satisfactory response.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The substance was non mutagenic under the conditions of the test.
Executive summary:

The test susbtance was negative in an Ames test (bacterial reverse mutation assay according to Annex V, GLP) with and without metabolic activation: No increase in mutation rate was seen in two independent experiments (species/strains tested: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100).