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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro DNA damage and/or repair study
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-11-15 to 2000-12-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Original study in Japanese, only summary in English available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
1) Dose finding test: 1.2 µg/plate, 4.9 µg/plate, 20 µg/plate, 78 µg/plate, 313 µg/plate, 1250 µg/plate, 5000 µg/plate.
2) Main test: 313 µg/plate, 625 µg/plate, 1250 µg/plate, 2500 µg/plate, 5000 µg/plate.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Positive controls:
yes

Results and discussion

Test resultsopen allclose all
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:
not determined
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Additional information on results:
In the dose-finding test and the main test, neither increase of more than two-fold in the number of revertant colonies when compared with the negative control nor dose-response relationship was observed in the plate at any dose level treated with the test article in both frameshift and base-pair substitution tester strains with or without metabolic activation.

A more than two-fold increase in the number of revertant colonies was observed in comparison with the negative control in the plate treated with the positive control article for each tester strain, thus it was determined that the study was conducted appropriately.

In conclusion, L-Glutamine was considered to be non-mutagenic under the conditions of this study.

There was neither growth inhibition nor precipitation of the test article on the plate with or without metabolic activation.

No bacterial proliferation was observed in sterility test of the test article and of the S9 mix.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

L-Glutamine did not show mutagenic acticivity in a GLP guideline study according to a Japanes test guideline. Testing was in absence and presence of the metabolic activation system S9 mix. The maximum dose was 5000 µg/plate.