Registration Dossier
Registration Dossier
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EC number: 701-227-4 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and scientifically good . Tests done according to standard protocol and GLP. Good quality.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cadmium telluride
- EC Number:
- 215-149-9
- EC Name:
- Cadmium telluride
- Cas Number:
- 1306-25-8
- Molecular formula:
- CdTe
- IUPAC Name:
- telluroxocadmium
- Details on test material:
- - Name of test material (as cited in study report): CdTe supplied by 5N Plus Inc (Montreal, Canada)
- Molecular formula : CdTe
- Molecular weight: 240.011
- Physical state: black powder
- Analytical purity: >99.99%
- Lot/batch No.: 115823
- Expiration date of the lot/batch: 2 years after that the bag is open
- Storage condition of test material: room temperature; under inert conditions
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: 1% methylcellulose solution
- Justification for choice of solvent/vehicle: Because the test item is insoluble in any solvent compatible for the test system, using thickener was necessary to keep the test item particles in stable suspension. At 100 mg/mL concentration, homogeneous stable suspension was obtained using 1 % aqueous solution of methylcellulose as thickener.
Controls
- Untreated negative controls:
- yes
- Remarks:
- 1% methylcellulose solution, DMSO, distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- methylcellulose solution, DMSO, distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- no
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
NUMBER OF REPLICATIONS: Triplicate - Evaluation criteria:
- no information
- Statistics:
- Not available
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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- none
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic for all the used bacterial strains (Salmonella typhimurium as well as Escherichia coli) with as well as without metabolic activation - Executive summary:
A study was conducted to determine the potential mutagenicity of the test material using bacterial reverse mutation assay (Ames test).
Four indicator Salmonella typhimurium strains TA98, TA100, TA1535 and TA 1537 and one indicator Escherichia coli WP2 uvrA strain were treated with fine suspensions of the test material using the plate incorporation method at doses of 15.81-5000 µg/plate).
Under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
The test item Cadmium telluride had no mutagenic activity on the growth of the applied bacterium tester strains under the test conditions used in this study.
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