Soybean oil, epoxidised, reaction products with methanol and water

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, epoxidized

EC Number:

232-391-0

EC Name:

Soybean oil, epoxidized

Cas Number:

8013-07-8

IUPAC Name:

8013-07-8

Method

Target gene:

tk locus in mouse lymphoma cells

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

S 9

Test concentrations with justification for top dose:

312.5; 625; 1250; 2500; 5000

Vehicle / solvent:

Acetone

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

4-nitroquinoline 1-oxide (without S-9) and benzo(a)pyrene (with S-9)

Migrated to IUCLID6: benzo(a)pyrene

Evaluation criteria:

The test substance was considered to be mutagenic if: 1) the assay was valid, 2) the mutant frequency at 1 or more doses was significantly greater than that of the negative control, 3) there was a significant dose-relationship as indicated by the linear trend analysis, and 4) the effects described above were reproducible.

Statistics:

according to the UKEMS guidelines. Thus the control log mutant frequency (LMF) was compared with the LMF from each treatment dose, and secondly the data were checked for a linear trend in mutant frequency with treatment dose. These tests required the calculation of the heterogeneity factor to obtain a modified estimate of variance.

Results and discussion

Test results

Test results 1

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

without

Genotoxicity:

negative

Remarks:

statistically significant increases in mutant frequency were observed at 2500 and 5000 ug/ml, which seemed attributable to slightly depressed viability counts, rather than any clear increase in the absolute number of mutants

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

statistically significant increases in mutant frequency were observed at 2500 and 5000 ug/ml, which seemed attributable to slightly depressed viability counts, rather than any clear increase in the absolute number of mutants

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

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

It is concluded that, under the conditions employed in this study, ESBO failed to demonstrate an ability to induce mutation at the tk locus of L5178Y mouse lymphoma cells in the absence and presence of S-9.