Sodium [N-[2-[bis(carboxylatomethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(3-)]zincate(1-)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

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

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

Specific details on test material used for the study:

Obtained from Merck Co., Darmstadt (Germany)

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

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

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:

All compounds were tested on 2 slightly different minimal media: one (in the following named ZLM medium) is a modified minimal medium for E. coli , and the other is the Vogel-Bonner (VB) medium. ZLM medium contained (in g/l): tri-Na- citrate.2H20 (0.82), K2HPO4-3H20 (4.60), KH2PO4 (1.50), (NH4)2SO4 (1.00), MgSO4.7H20 (0.10) and glucose (17.0).
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.

Statistics:

No statistics

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

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 1537

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 3

Species / strain:

S. typhimurium TA 98

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 4

Species / strain:

S. typhimurium 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 5

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

Applicant's summary and conclusion

Conclusions:

Mutagenicity of zinc sulfate was tested with a bacterial reverse mutation test. The outcome of the test was negative, both with and without metabolic activation.
Under the conditions of this test, zinc sulfate was considered to be non-mutagenic.

Executive summary:

Mutagenicity of zinc sulfate was tested with a bacterial reverse mutation 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.