Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
refer to confidential details on test material
IUPAC Name:
refer to confidential details on test material

Method

Species / strain
Species / strain / cell type:
other: S.Typhimurium TA98, TA100, TA1535, Ta1538, E. Coli WP2 uvrA
Metabolic activation system:
S9 mix rat and hamster
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 4 ... 5000 μg/plateConcentration range in the main test (without metabolic activation): 4 ... 5000 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 10000 ug/plate
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 10000 ug/plate

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negative with metabolic activationnegative without metabolic activationThe substance was tested for genetic toxicity in vitro following OECD 471 (Ames test). Under the experimental conditions the substance did not show any mutagenic properties.
Executive summary:

The substance was tested for genetic toxicity in vitro following OECD 471 (Ames test). Under the experimental conditions the substance did not show any mutagenic properties.