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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
December 08, 1998 - January 19, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed according to OECD and/or EC guidelines, and according to GLP principles. The data relating to the identity, purity and stability of the test material are not mentioned in the test report but can be retrieved from the original NONS notification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annec V (Bacterial gene mutation)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: CETEC 2254

Method

Species / strain
Species / strain / cell type:
other: Salomonella typhimurium strains TA1535, TA1537, TA98, and TA100. Escherichia coli strain WP2uvrA-.
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver S9 fraction
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: Acetone
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 5000 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)
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations:
Vehicle control plates gave counts of revertant colonies
within the normal range. All positive control chemicals used
in the test induced marked increases in the frequency of
revertant colonies with and without activation. The test
material caused no visible reduction in the growth of the
bacterial lawn at any dose level. The test material was
therefore tested up to the maximim recommended dose of 5000
ug/plate. No significant increases in frequency of revertant
colonies were recorded for any of the bacterial strains,
with any dose of the test material with or without
activation.
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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