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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:
1983
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:
study report
Title:
Unnamed
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
no guideline available
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

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:
20, 100, 500, 2500, 12500 ug/per plate
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
cyclophosphamide
other: Tripaflavine and 2-aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Applicant's summary and conclusion

Conclusions:
negative with and without metabolic activation
The test item is not mutagenic in this Ames test
Executive summary:

This study was performed to investigate the potential of the test item, to induce reverse mutation in Salmonella typhimurium.

The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix.

Four strains of bacteria S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 were used. Each strain was exposed to five concentration levels 20, 100, 500, 2500, 12500 ug/per plate

Concurrent untreated negative and positive controls were evaluated.

The substance was found as negative with and without metabolic activation for genotoxicity