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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:
June 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed by a highly experienced laboratory

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: The study was performed in 1980 and the published proceedures by Bruce Ames and others were cited in the references included in the study.
Deviations:
not applicable
Principles of method if other than guideline:
Standard laboratory practices followed
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
T-2476ChR
IUPAC Name:
T-2476ChR
Constituent 2
Chemical structure
Reference substance name:
Isooctyl acrylate
EC Number:
249-707-8
EC Name:
Isooctyl acrylate
Cas Number:
29590-42-9
Molecular formula:
C11H20O2
IUPAC Name:
6-methylheptyl acrylate
Details on test material:
- Name of test material (as cited in study report: T-2467ChR
- Physical state:Clear Liquid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Stability under test conditions: Stable
- Storage condition of test material: room temperature

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
other: D3 strain of S. cerevisiae
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S-9; SRI Batch #D4, ca. 30mg/mL protein
Test concentrations with justification for top dose:
0.0005 to 5.0 uL/plate; mutiple assays
Vehicle / solvent:
Dimethylsulfoxide (DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
other: Solvent control only
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: 2-Anthramine
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: 4 hours
- Exposure duration: 48 hours
Evaluation criteria:
3X+ control background

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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: S. cervisiae D3
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- 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 expert judgment

T-2476ChR is not mutagenic with S. typhimurium or recombinogenic with S. cerevisiae D3
Executive summary:

Compound T-2476ChR was tested for mutagenicity with the Ames Salmonella/microsome assay and with the yeast Saccharomyces cerevisiae D3 assay in the presence and in the absence of a metabolic activation system. The compound was tested at least twice on separate days in both assays.

Dimethylsulfoxide (DMSO) was used as the solvent in all assays.

In the Ames Salmonella/microsome assay, Compound T-2476ChR was tested initially in a preliminary assay with S. typhimurium strain TA100 over a wide range of concentrations, from 0.01 to 5.0 ul/plate Pinpoint colonies (indicating toxicity) appeared at 5.0 ul/plate, so the concentration range was lowered to 0.0005 to 0.5 ul/plate in subsequent tests using all five strains of S. typhimurium. At 0.5 ul/plate, the test compound was toxic with TA100, but no dose-related increase in the number of revertants per plate was observed in either assay.

In the microbiological assays with S. cerevisiae D3, T-2476ChR was initially tested over a wide range of concentrations, from 0.01 to 5.0% Toxicity was observed at all concentrations so the range was lowered to 0.00005 to 0.05% for subsequent testing. No dose-related increase in the number of mitotic recombinants above background was observed.

The test material, T-2476ChR was negative in this assay.