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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40'224/C
- Description: orange 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:
aroclor 1254 induced rat liver S9 mix
Test concentrations with justification for top dose:
20, 80, 320, 1280, 5120 µg/plate.
Vehicle / solvent:
distilled water
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-anthramine
Remarks:
Strain TA 1535, TA 1537, TA 98, TA 100 with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidine
Remarks:
Strain TA 1535 and TA 100 without metabolic activation system
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Strain TA 1537 without metabolic activation system
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: daunomycine
Remarks:
Strain TA 98 without metabolic activation system
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar

DURATION
The plates were incubated for 48 hours at 37°C in the dark.

NUMBER OF REPLICATIONS: 3

OTHER EXAMINATIONS:
An examination under the microscope was used to verify the presence of the background produced by growth of auxotrophic bacteria on traces of histidine and biotin, or the absence of background due to a toxic effect of the test substance.
Evaluation criteria:
The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate accompanied by a dose-effect relationship.

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
Remarks:
The toxicity was evaluated in a preliminary test with the TA 98 strain, no toxicity was shown at 5120 µg/plate (the highest dose in the main test).
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Preliminary test: The toxicity of the product was evaluated in a preliminary test to fix the highest dose to be evaluated in the main test. A quantitative test was performed with the strain TA 98, in the presence and absence of S-9 mix, at three concentrations: 51.2, 512 and 5120 µg/plate. The tests were made in duplicate. As no toxicity was shown at 5120 µg/plate, the standard concentrations of 20, 80, 320, 1280 and 5120 µg were chosen.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance did not show any mutagenic activity in any strain.
Executive summary:

In two independent GLP compliant Ames tests, performed according to OECD guideline 471, 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) were used to test the mutagenic potential of the test substance (20, 80, 320, 1280 and 5120 µg/plate), both with and without metabolic activation system. The test substance did not show any mutagenic activity in any strain.