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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:
Jul. 18 - 26, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Titanium trichloride
EC Number:
231-728-9
EC Name:
Titanium trichloride
Cas Number:
7705-07-9
Molecular formula:
Cl3Ti
IUPAC Name:
titanium trichloride
Test material form:
solid: crystalline
Details on test material:

- Name of test material (as cited in study report): Titanium Trichloride
- Molecular formula (if other than submission substance): TiCl3
- Molecular weight (if other than submission substance): 154.2 g/mol
- Substance type: inorganic
- Physical state: solid
- Lot/batch No.: C1Y0927
- Storage condition of test material: room temperature, in proper conditions
- CAS: 7705-07-9; 1318239-01-08
- EINECS 231-728-9
Specific details on test material used for the study:
Titanium Trichloride, Batch no. C1Y0927, violet powder, Composition > 99% Titanium Trichloride, Purity > 99%, Homogeneity homogeneous, Expiry date Nov. 2018

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 97a, TA98, TA100, TA102. TA1535
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
The following nominal concentrations were prepared for the first experiment for all five bacteria strains: 3700 μg/plate, 1110 μg/plate, 370 μg/plate, 111 μg/plate, 37 μg/plate, 11 μg/plate, 3.7 μg/plate, 1.1 μg/plate, 0.37 μg/plate and 0.11 μg/plate
The following nominal concentrations were prepared for the second experiment for the bac-teria strains TA97a, TA98 with metabolic activation, TA100, TA102 and TA1535: 3700 μg/plate, 1850 μg/plate, 925 μg/plate, 462.5 μg/plate, 231.3 μg/plate, 115.6 μg/plate, 57.8 μg/plate and 28.9 μg/plate
The following nominal concentrations were prepared for the second experiment for the bac-teria strain TA98 without metabolic activation: 370 μg/plate, 185 μg/plate, 93 μg/plate, 46.3 μg/plate, 23.1 μg/plate, 11.6 μg/plate, 5.8 μg/plate and 2.9 μg/plate
Vehicle / solvent:
DMSO
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
other: nitrophenylendiamine, 2-amino-anthracene
Statistics:
The colonies were counted visually and the numbers were recorded. A validated spread-sheet software (Microsoft Excel®) was used to calculate mean values and standard devia-tions of each treatment, solvent control and positive control.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 97
Remarks:
TA97a
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
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:
not determined
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:
not determined
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:
not determined
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
cf. tables below for more details

Any other information on results incl. tables

The results of the first experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.

The results of the second experiment showed that the test item caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.

Applicant's summary and conclusion

Conclusions:
Based on the results of this study it is concluded that Titanium Trichloride 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.
Executive summary:

An Ames test in salmonella strains was conducted with titanium trichloride.