Registration Dossier
Registration Dossier
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EC number: 406-260-5 | CAS number: 58834-75-6 BTN; VPO CATALYST
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity of vanadium compounds in yeast and cultured mammalian cells
- Author:
- Galli, A.et al.
- Year:
- 1 991
- Bibliographic source:
- Teratog Carcinog Mutagen. 11(4):175-83
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Vanadium oxide sulphate
- EC Number:
- 248-652-7
- EC Name:
- Vanadium oxide sulphate
- Cas Number:
- 27774-13-6
- IUPAC Name:
- oxovanadium(2+) sulfate
- Details on test material:
- - Name of test material (as cited in study report): vanadyl sulfate
- Supplier: Merck (Darmstadt, Germany)
- Analytical purity: no data
- Storage condition of test material: under nitrogen atmosphere
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- mouse hepatic S-9 mix
- Test concentrations with justification for top dose:
- 1, 2, 5,. 7.5 mM
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 30 mM
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 10 mM
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Expression time (cells in growth medium): 0, 144, 240 h
NUMBER OF REPLICATIONS: 4 independent experiments
NUMBER OF CELLS EVALUATED: 20^6
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Statistics:
- Student's t-test
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity at highest concentration without metabolic activation
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Induction of 6 -thioguanine resistance in V79 mammalian cells after vanadyl sulfate treatment with and without S-9 hepatic fraction at different expession times:
| Concentration (mm) | Survival | 6TG resistants / 10^6 viable cells | ||||||
| without metabolic activation | with metabolic activation | without metabolic activation | with metabolic activation | |||||
| t0 | t144 | t244 | t0 | t144 | t244 | |||
| control | 100 | 100 | 3.41 ± 1.21 | 3.86 ± 1.23 | 3.12 ± 1.10 | 5.27 ± 2.40 | 5.51 ± 2.39 | 5.34 ± 1.50 |
| 1 | 75 | 89 | 5.40 ± 1.46 | 3.92 ± 1.70 | 2.86 ± 0.91 | 7.36 ± 2.61 | 4.37 ± 1.82 | 3.20 ± 1.25 |
| 2 | 28 | 100 | 7.29 ± 3.67 | 2.68 ± 0.68 | 4.14 ± 2.01 | 6.31 ± 2.74 | 6.71 ± 2.09 | 1.35 |
| 5 | 20 | 100 | 3.28 ± 1.28 | 1.68 ± 0.20 | 1.98 ± 0.18 | 6.30 ± 1.09 | 9.10 ± 2.85 | 11.30 ± 4.96 |
| 7.5 | tox | 85 | - | - | - | 7.70 ± 2.30 | 10.70 ± 3.71 | 4.10 ± 1.94 |
| EMS (30 mM) | 52 | - | 4.22 ± 1.47 | 713 ± 32.6* | - | - | - | - |
| DMN (10 mM) | - | 60 | - | - | 4.29 ± 1.36 | 986 ± 152* | - | |
*p<0.001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
DSD: not classified
CLP: not classified
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