Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
other: part of the SNIF file, no further data
Rationale for reliability incl. deficiencies:
other: Part of the SNIF file, which was accepted by the UK national authority for NONS

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (Ames)
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 strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA-
Metabolic activation system:
Phenobarbitone/ beta-naphthoflavone induced rats liver
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Tetrahydrofuran
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 1500 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Additional information on results:
Observations:
The test material caused no visible reduction in the growth
of the background lawn at any dose level.


A precipitate (oily in appearance) was observed at and above
1500 micrograms per plate, this did not prevent the scoring
of revertant colonies.


No significant increases in the frequency or revertant were
recorded for any of the bacterial strains, with any dose of
the test material, either with or without metabolic
activation.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Part of the SNIF file, which was accepted by the UK national authority for NONS

Applicant's summary and conclusion

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