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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
Deviations:
yes
Principles of method if other than guideline:
Method (Type of test): AMES B.N., 1973, 1973 and 1975
The only difference with the annex V method was the use of strain TA 102 instead of TA 1538.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
no data
Species / strain
Species / strain / cell type:
other: TA 98, TA 100, TA 102, TA 1535 and TA 1537
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S 9 liver fractions of rats treated with AROCLOR 1254
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20, 78, 313, 1250 and 5000 µg/0.1mL
Concentration range in the main test (without metabolic activation): 20, 78, 313, 1250 and 5000 µg/0.1mL

Results and discussion

Any other information on results incl. tables

Concentration producing toxicity in the preliminary test:

- with metabolic activation: > 5000 µg/0.1 mL

- without metabolic activation: > 5000 µg/0.1 mL

Concentration producing toxicity in the main test:

- with metabolic activation: > 5000 µg/0.1 mL

- without metabolic activation: > 5000 µg/0.1 mL

Conclusion:

Negative with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation concentration producing toxicity in the main test > 5000 µg/0.1 mL
negative without metabolic activation concentration producing toxicity in the main test > 5000 µg/0.1 mL

The test substance is not considered to be mutagenic (both with and without metabolic activation) in this Ames test.