Fatty acids, C14-18 and C16-18-unsatd., zinc salts

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 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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

Zinc sulphate

EC Number:

231-793-3

EC Name:

Zinc sulphate

Cas Number:

7733-02-0

Molecular formula:

H2O4S.Zn

IUPAC Name:

zinc sulfate

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 / strain

Species / strain 1

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 2

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 results

Test results 1

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

Test results 2

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.