Registration Dossier
Registration Dossier
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EC number: 270-185-2 | CAS number: 68412-38-4 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77899.
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- (missing tester strain to detect crosslinking/oxidising agents, non-GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Remarks:
- missing tester strain to detect crosslinking/oxidising agents according to latest OECD 471 guideline
- Principles of method if other than guideline:
- Standard plate test (repeated with identical concentrations)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Manganese antimony titanium buff rutile
- EC Number:
- 270-185-2
- EC Name:
- Manganese antimony titanium buff rutile
- Cas Number:
- 68412-38-4
- Molecular formula:
- Mn(x/3)Sb(2x/3)Ti(1-x)O2 0,05≤x≤0,60
- IUPAC Name:
- Manganese antimony titanium rutile
- Details on test material:
- - Storage condition of test material: 4°C
Constituent 1
Method
- Target gene:
- his-
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 0, 20, 100, 500, 2500 and 5000 ug/ plate
- Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: with S-9 mix: 10 ug 2-aminoanthracene (all strains); without S-9 mix: 5 ug N-methyl-N'-nitro-N-nitroso-guanidine for the strains TA 100 and TA 1535; 10 ug 4-nitro-o-phenylenediamine for the strain TA 98; 100 ug 9-aminoacridine chloride monohydrate for t
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Complete solubility of the test substance in DMSO.
Any other information on results incl. tables
| 1st Standard Plate Test | |||||
| Solvent: DMSO | |||||
| Strain | Metabolic activation system | Replicates | maximum revertant factor | dose dependency | Assessment |
| TA 1535 | no | 3 | 1.2 | yes | negative |
| yes | 3 | 1.3 | no | negative | |
| TA 100 | no | 3 | 1.1 | no | negative |
| yes | 3 | 1.1 | no | negative | |
| TA 1537 | no | 3 | 1.3 | no | negative |
| yes | 3 | 1.4 | no | negative | |
| TA 98 | no | 3 | 1.1 | no | negative |
| yes | 3 | 1.0 | no | negative | |
| 2nd Standard Plate Test | |||||
| Solvent: DMSO | |||||
| Strain | Metabolic activation system | Replicates | maximum revertant factor | dose dependency | Assessment |
| TA 1535 | no | 3 | 1.0 | no | negative |
| yes | 3 | 1.3 | no | negative | |
| TA 100 | no | 3 | 1.1 | no | negative |
| yes | 3 | 1.0 | no | negative | |
| TA 1537 | no | 3 | 0.9 | no | negative |
| yes | 3 | 1.1 | no | negative | |
| TA 98 | no | 3 | 1.1 | no | negative |
| yes | 3 | 1.1 | no | negative | |
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic under the conditions of the test.
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