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Toxicological information

Genetic toxicity: in vitro

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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

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 resultsopen allclose all
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
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.