Registration Dossier
Registration Dossier
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EC number: 296-292-4 | CAS number: 92457-12-0
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:
- 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Registration dossier
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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
- Reference substance name:
- Jojoba, ext., hydrogenated
- EC Number:
- 296-292-4
- EC Name:
- Jojoba, ext., hydrogenated
- Cas Number:
- 92457-12-0
- Molecular formula:
- No molecular formula is available since it is a UVCB substance
- IUPAC Name:
- Jojoba (Simmondsia Chinensis) Seed Oil Hydrogenated
- Test material form:
- solid: flakes
Constituent 1
Method
- Target gene:
- Name Category Effect
hisD6610 frame shift histidine deficiency
hisD3052 frame shift histidine deficiency
hisG46 base pair substitution histidine deficiency
hisG428 base pair substitution histidine deficiency
uvrB deletion UV sensitivity, biotin deficiency
rfa deletion lipopolysaccharide side chain deficiency
pKM101 plasmid ampicillin resistance
pAQ1 plasmid tetracycline resistance
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- In a non-GLP pre-test, the solubility of the test item was tested in demineralized water, dimethyl sulfoxide (DMSO), ethanol and tetra hydrofurane (THF).
Ethanol was chosen as vehicle, because the best result of a homogeneous and pipetta-ble suspension was achieved with this solvent and it does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentra-tions.
On the day of the start of the first and the second experiment, all concentrations were weight directly. The following nominal concentrations were prepared for the first experiment: 5000 µg/plate, 1500 µg/plate, 500 µg/plate, 150 µg/plate and 50 µg/plate.
The following nominal concentrations were prepared for the second experiment: 5000 µg/plate, 2500 µg/plate, 1250 µg/plate, 625 µg/plate, 313 µg/plate and 156 µg/plate. - Vehicle / solvent:
- Ethanol
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylenediamine, 2-Amino Anthracene
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Jojoba Oil hydrogenated is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
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