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Toxicological information

Genetic toxicity: in vitro

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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:
2017
Report Date:
2017

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

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.