Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
other: Report summary
Adequacy of study:
supporting study
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is based on study summary.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): SC-65872

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium (TA97a, TA98, TA100, TA1535 and TA102).
Metabolic activation:
with and without
Metabolic activation system:
rat liver homogenate metabolic activation system
Test concentrations with justification for top dose:
10 to 5000 mcg/plate
Vehicle / solvent:
100 mg/ml in dimethylsulfoxide (DMSO)
Details on test system and experimental conditions:
Testing was performed with and without a rat liver homogenate metabolic activation system over test article concentrations ranging from 10 to 5000 mcg/plate.

Results and discussion

Test results
Species / strain:
other: TA97a, TA98, TA100, TA1535 and TA102
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
not mutagenic
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: TA97a, TA98, TA100, TA1535 and TA102
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative Not mutagenic under the conditions of this test system.

SC-66276 is not mutagenic under the conditions of this test system.
Executive summary:

Test substance is not mutagenic under the conditions of the test system.