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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:
July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
T-7145
IUPAC Name:
T-7145
Details on test material:
- Name of test material (as cited in study report) T-7145
- Physical state: liquid 99.89%
- Impurities (identity and concentrations): impurity identites not reported. 0.11%
- Stability under test conditions: Stable

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 AND WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
5, 20, 78, 313, 1250, 5000 micrograms/plate
Vehicle / solvent:
Acetone was be approved solvent in which the test material was soluble.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 9-aminoacridine N-ethyl-N'-nitro-N-nitrosoguanidine, 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION:
Preincubation;

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
Evaluation criteria:
2X+ control background
Statistics:
NA

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: N.A.
- Effects of osmolality: N.A.
- Evaporation from medium: N.A.
- Water solubility: very low water solubility
- Other confounding effects: None
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

T-7145 is negative in all strains tested
Executive summary:

In the main test, the numbers of revertants induced by the test substance were not increased more than double of the solvent control value with and without S9 mix. The reproducibility of this negative result was confirmed.

In the contamination test, others bacteria was not observed.

Mircrobial growth inhibition was not observed. Precipitated test substance was not observed on the agar plate.

In the positive control tests using specific mutagens with and without S9 mix, they induced significant revertants exceeding those of the solvent control. For solvent control and positive control, the numbers of revertants of all the tester strains were within the normal range of our laboratory's background data respectively. These results assured that the tests were performed correctly.

These results led to the conclusion that T-7145 is not mutagenic under the test conditions employed.