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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 applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity studies in a tyre plant: in vitro activity of workers' urinary concentrates and raw materials
Author:
Crebelli R, Paoletti A, Falcone E, Aquilina G, Fabri G and Carere A
Year:
1985
Bibliographic source:
Br. J. Ind. Med. 42(7):481-487

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(No data of negetive control)
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Zinc oxide
- Substance type: Pure active substance
- Physical state : No data
- Analytical purity: 99%

Method

Target gene:
No data
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction from Aroclor induced male Sprague-Dawley rats
Test concentrations with justification for top dose:
1000-5000 µg/plate
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: at 5 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene at 1 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine at 5 µg/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: In agar (plate incorporation)
NUMBER OF REPLICATIONS: Triplicate
Evaluation criteria:
Positive response: Induction of reproducible dose related increases in the number of his+ revertants in the treated group compared to the control.
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
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 with metabolic activation
negative without metabolic activation

The test material was considered to be non-mutagenic under the condition of this test.
Executive summary:

A study was conducted to determine the potential mutagenicity of Zinc oxide using bacterial reverse mutation assay.

Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 were treated with the test material using the plate incorporation method at dose levels ranging from 1,000 to 5,000 µg/plate in triplicate in presence and absence of a metabolic activation system.

No significant increases in the frequency of his+ revertant colonies were recorded at the dose range tested.

The test material was considered to be non-mutagenic under the conditions of this test.