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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals
Author:
Mortelmans, K.; Haworth, S.; Lawlor, T.; Speck, W.; Tainer, B.; Zeiger, E.
Year:
1986
Bibliographic source:
Environmental Mutagenesis Vol. 8, Supplement 7, 1-119

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
10, 33, 100, 333, 1000, 3333, 6666 µg/plate
Vehicle / solvent:
Dimethyl Sulfoxide
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2-Aminoanthracene, 4-Nitro-O-Phenylenediamine

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
333 µg/well
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
The test item is positive in an bacteria reverse mutation assay with and without metabolic activation in the strain Salmonella typhimurium TA1535.
Executive summary:

The test item has been tested for mutagenic potential in bacteria in an bacteria reverse mutation assay (Ames test) according to international accepted protocolls. The following concentrations were tested: 10, 33, 100, 333, 1000, 3333, 6666 µg/plate with and without metabolic activation (S9 -mix) on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100.

The test item was positive in S. typhimurium TA 1535 at 333 µg/plate with and without metabolic activation.