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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:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test compliant with GLP and Guideline Commission Directive 200/32/EC

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Commission Directive 2000/32/EC, L 1362000, Annexe 4D OECD 471 (1997)
Deviations:
not specified
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 starins TA 1535, TA 1537, TA 98 and TA 100, and Escherichia coli strain WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
systemPhenobarbital/beta-Naphthoflavone induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 33 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 33 ... 5000 μg/plate
Vehicle / solvent:
Solvent: TA 100, and Escherichia coli strain WP2 uvrA

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:
(> 2500 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>1000μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>2500μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>333μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Observations:
Phenobarbital/beta-Naphthoflavone induced rat liver S9
Remarks on result:
other: other: preliminary test
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