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Diss Factsheets

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:
April-July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted according to OECD guideline and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Soybean oil, epoxidized, acrylate
EC Number:
294-415-6
EC Name:
Soybean oil, epoxidized, acrylate
Cas Number:
91722-14-4
Molecular formula:
C63H108O15
IUPAC Name:
Soybean oil, epoxidized, acrylate
Details on test material:
- Name of test material (as cited in study report): C-SAT 040012 (PHOTOMER 3005 F)
- Substance type: UVCB
- Physical state: yellowish, viscous liquid
- Analytical purity: 100%
- Lot/batch No.: S74.0750027
- Expiration date of the lot/batch: 15 September 2004
- Storage condition of test material: room temperature, protected from light

Method

Target gene:
histidine gene in Salmonella typhimurium
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9 mix
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle:
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: Without metabolic activation: sodium azide for TA 1535 and TA 100; 4-nitro-o-phenylene-diamine for TA 1537 and TA 98; methyl methane sulphonate for TA 102. With metabolic activation: 2-aminoanthrace with all strains.
Details on test system and experimental conditions:
The assays were performed in four independent experiments, all with and without liver microsomal activation. Due toxic effects caused by the solvent ethanol in exp. II in strain TA 100 without S9 mix and strain TA 102, with and without S9 mix, this experiment was repeated twice. Once with application volume of 100 µl (not reported) and a second with an application volume of 50 µl (reported as exp. II). Each concentration, including the controls, was tested in triplicate.
Evaluation criteria:
The Salmonella typhimurium reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of the historical control data of the laboratory
- the positive control substances should producer a significant increase in mutant colony frequencies

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
A reduced background growth was observed from 2500 to 5000 µg/plate with and without metabolic activation in the first experiment and with metabolic activation in the second experiment. No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation.

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test substance at any concentration level, neither in the presence nor absence of metabolic activation. There was also no tendency of higher mutation rates with increasing concentrations inthe range below the generally accepted border of biological relevance.
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

Under the experimental conditions reported, the test substance did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test substance is considered to be non-mutagenic in the Salmonella typhimurium reverse mutations assay.
Executive summary:

The study was performed to investigate the potential of the test substance to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.

The assays were performed in four independent experiments, all with and without liver microsomal activation. Due toxic effects caused by the solvent ethanol in exp. II in strain TA 100 without S9 mix and strain TA 102, with and without S9 mix, this experiment was repeated twice. Once with application volume of 100 µl (not reported) and a second with an application volume of 50 µl (reported as exp. II). Each concentration, including the controls, was tested in triplicate.

The test substance was tested at the following concentrations: 33, 100, 333, 100, 2500 and 5000 µg/plate.

The plates incubated with the test item show normal background growth up to 5000 µg/plate with an without S9 mix in all strains used in experiment I. Reduced background growth was observed in experiment II from 2500 to 5000 µg/plate in strains with and without metabolic activation, only.

Toxic effects, evident as a reduction in the number of revertants, occurred in experiment II in strains TA 1537 (1000-5000 µg/plate) and TA 98 (2500-5000 µg/plate) without metabolic activation only.

No substantial increase in revertant colony numbers of any of the tester strains was observed following treatment with the test substances at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency og higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological significance.

Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.