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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, short report, few details but meets basic scientific principles.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: According to "Ames BN, McCann J & Yamasaki E (1975). Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mutat. Res., 31: 347-364".
GLP compliance:
not specified
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): Zinc sulfate
- Other: Obtained from Merck Co., Darmstadt (Germany)

Method

Target gene:
Not applicable
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 1538
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 liver fraction from Aroclor-pretreated rats
Test concentrations with justification for top dose:
At least 5 doses, up to 3,600 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: no data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Details on test system and experimental conditions:
METHOD OF APPLICATION: In medium; test material was tested on 2 slightly different minimal media, the composition of which are as follows:

1. ZLM medium
- Tri-Na citrate·2H2O = 0.82 g/L
- K2HPO4·3H2O = 4.60 g/L
- KH2PO4 = 1.50 g/L
- (NH4)2SO4 = 1.00 g/L
- MgSO4·7H2O = 0.10 g/L
- Glucose = 17.0 g/L

2. Vogel-Bonner (VB) medium
The concentration of citrate was 3.5 times higher in VB medium than in ZLM medium. The concentrations of the other ions are up to 2-fold higher in VB medium.
Evaluation criteria:
Not available
Statistics:
Not available

Results and discussion

Test resultsopen allclose all
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:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
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

Under the conditions of this test, test material was considered to be non-mutagenic.

Executive summary:

A study was conducted to determine the potential mutagenicity of the test material using bacterial reverse mutation assay (e.g. Ames test). 

Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA1538 strain were treated with the test material in Vogel-Bonner (VB) & ZLM medium (modified minimal medium for E. coli) at minimal five dose levels, up to 3,600 µg/plate, both with and without activation by the S9 liver fraction from Aroclor-pretreated rats.

 

The positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. No significant increases in the frequency of revertant colonies were observed for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.

 

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