Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test

Method

Target gene:
no data
Species / strain
Species / strain / cell type:
S. typhimurium, 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.