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 with acceptable restrictions

Data source

Reference
Reference Type:
other: inqurity result from ECHA
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Test Method in Annex Ⅴ (B.14) of Dir. 84/449/EEC
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium/ tester strains TA1535, TA1537. TA98 and TA100
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): >=1 ... <=100 μg/plate
Concentration range in the main test (without metabolic activation): >=1 ... <=100 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(100 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(100 μg/plate)
Additional information on results:
Observations:
The test substance induced statistically significant dose-related increase in number of revertant (His+) colonies in TA1535, TA98 and TA100 either with or without metabolic activation.

The tester strain TA1537 showed negative respons over the entire dose range of the test substance i.e. no dose-related increase of the number of revertants in two independently repeated experiments.

The negative and strain specific positive control values fell within labo background historical range.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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