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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Method

Target gene:
Not applicable
Species / strain
Species / strain / cell type:
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 results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2
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.