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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:
25 February 2008 to 24 March 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Deviation: no analytical certificate of test item
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): CAE
- Substance type: UVCB
- Physical state: liquid
- Analytical purity, Impurities: not applicable (UVCB)
- Lot/batch No.: 1456
- Expiration date of the lot/batch: 31/12/2008
- Storage condition of test material: away from light, under nitrogen, at room temperature

Method

Target gene:
Histidine operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 102
Details on mammalian cell type (if applicable):
- Type and identity of media: agar
- Properly maintained: purchased
- Periodically checked for Mycoplasma contamination: not applicable (purchased)
- Periodically checked for karyotype stability: not applicable (purchased)
- Periodically "cleansed" against high spontaneous background: not applicable (purchased)
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
- Type and identity of media: agar
- Properly maintained: purchased
- Periodically checked for Mycoplasma contamination: not applicable (purchased)
- Periodically checked for karyotype stability: not applicable (purchased)
- Periodically "cleansed" against high spontaneous background: not applicable (purchased)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
5, 1.5, 0.5, 0.15, 0.05 µL/plate for each strain ate in each experiment.
Vehicle / solvent:
None (liquid tgest item).
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: 9-Aminoacridine ; 2-Nitrofluorene ; Mitomycin C; 2-Aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar
First experiments by direct plate incorporation.
Second experiments by preincubation.

DURATION
- Preincubation: 20 min
- Exposure duration: 72 h
Evaluation criteria:
A reproducible increase in the number of revertants compared with the negative controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Biological significance: from a 2.5-fold increase.
Statistics:
Not applicable.

Results and discussion

Test results
Species / strain:
other: all tested strains
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
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 item did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.