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

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Test performed according to: Schmid, W.: The micronucleus test for cytogenic analysis, in: A. Hollaender (Ed.), Chemical Mutagens, Vol. 4, 1976, 31-53.

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

, low animal number per dose group, purity of the test substance not stated, no PCE/NCE ratio given, and no toxic effects reported

GLP compliance:

not specified

Type of assay:

micronucleus 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)

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mice were obtained from S. Ivanovas GmbH and Co., KIsslegg/Allgäu (Germany).
- Diet: ad libitum, standard chow
- Water: ad libitum
No further details are given.

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: 0.375M phosphate buffer, pH 7.2

Details on exposure:

Animals treated at 0 and 24 h, bone-marrow smears prepared at 30 h

Duration of treatment / exposure:

30 hours

Frequency of treatment:

The animals were treated at 0 and 24 hours.

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
96.1 mg/kg
Basis:
nominal conc.

Doses / concentrations 2

Remarks:

Doses / Concentrations:
48.0 mg/kg
Basis:
nominal conc.

Doses / concentrations 3

Remarks:

Doses / Concentrations:
24.0 mg/kg
Basis:
nominal conc.

No. of animals per sex per dose:

4 mice (2 male and 2 female animals) were used for each dose.

Control animals:

yes

Positive control(s):

Pyrogallol, i.p.

Examinations

Tissues and cell types examined:

After 30 hours bone marrow smears were prepared.

Details of tissue and slide preparation:

Slides were coded and 1000 polychromatic erythrocytes were scored per mouse.

Statistics:

Significance was calculated according to the Kastenbaum-Bowman tables.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Remarks:

One animal died in the 24 mg/kg dose-group.

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

not examined

Additional information on results:

Dose, MN PCE(%), Survival
0.0 mg/kg: 1.9, 4/4
24.0 mg/kg: 2.9, 3/4
48.0 mg/kg: 1.9, 4/4
96.1 mg/kg: 1.8, 4/4

-Positive control increased MN PCE ratio significantly and dose-dependent (low dose 3,8%, mid dose 14.7%, high dose 25.4%)
-No further toxic effects reported
-No PCE/NCE ratio given

Applicant's summary and conclusion

Conclusions:

Mutagenecity of zinc sulfate was tested with a micronucleus test on mouse bone marrow. Zinc sulfate was found to be negative In this study , no significant exerted mutagenic action was observed.