Registration Dossier
Registration Dossier
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EC number: 924-751-7 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 26 June 2020
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- sunflower oil (Helianthus annuus L.), reaction products with ozone
- EC Number:
- 924-751-7
- IUPAC Name:
- sunflower oil (Helianthus annuus L.), reaction products with ozone
Constituent 1
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolising system
- Test concentrations with justification for top dose:
- 5,00; 2.50; 1.25; 0.62; 0.31 ug/plate
- Vehicle / solvent:
- DMSO
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: all treated strain
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- No evidence of toxicity at the highest dose of 5ul/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test item "OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL)" in the experimental conditions described, is not mutagenic.
All the acceptance criteria were passed. - Executive summary:
The test item "OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL)" was tested in the reverse mutation test according to OECD 471 and in compliance with GLP. The number of revertant colonies in any strain treated with OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL) did not exceed twice the corresponding number obtained in the negative control either in the presence or absence of metabolic activation. There was no dose-dependent increase in the number of revertant colonies observed. No growth inhibition was detected, no precipitation of the test item was observed.
All acceptance criteria were passed.
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