Isooctyl acrylate

Genetic toxicity: in vitro

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

Test material information

Constituent 1

Reference substance name:

T-2476ChR

IUPAC Name:

T-2476ChR

Constituent 2

Reference substance name:

Isooctyl acrylate

EC Number:

249-707-8

EC Name:

Isooctyl acrylate

Cas Number:

29590-42-9

Molecular formula:

C11H20O2

IUPAC Name:

2-methylheptyl prop-2-enoate

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

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 results

Test results 1

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

Test results 2

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.