Zinc fluoride

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:

key study

Study period:

Not reported

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 of Cosmetics Ingredients Licensed by the European Communities

Author:

Gocke E, King M-T, Eckhardt K & Wild D

Year:

1981

Bibliographic source:

Mutat. Res. 90: 91-109

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A micronucleus test on mouse bone marrow was conducted to evaluate the mutagenic potential of test material.

GLP compliance:

not specified

Type of assay:

micronucleus 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 sulphate
- Other: 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: S. Ivanovas GmbH and Co., Kisslegg/Allgau (Germany)
- Diet: Standard chow (Altromin GmbH, Lage, Germany), ad libitum
- Water: Ad libitum

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: No data

Details on exposure:

No data

Duration of treatment / exposure:

30 h

Frequency of treatment:

Twice, at 0 and 24 h

Post exposure period:

No data

Doses / concentrations

Remarks:

Doses / Concentrations:
2 X 86.3, 2 X 57.5 and 2 x 28.8 mg/kg (treated twice, at 0 and 24 h)
Basis:
other: solution in 0.9% Sodium chloride

No. of animals per sex per dose:

2

Control animals:

yes

Positive control(s):

No data

Examinations

Tissues and cell types examined:

Polychromatic erythrocytes

Details of tissue and slide preparation:

DETAILS OF SLIDE PREPARATION: Bone marrow smears were prepared at 30 h.


METHOD OF ANALYSIS: Slides were coded and 1000 polychromatic erythrocytes were scored per animal.

Evaluation criteria:

No data

Statistics:

Significance was calculated according to the Kastenbaum-Bowman tables.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Any other information on results incl. tables

Table 1: Results of the micronucleus test on mouse bone marrow

Compound	Surviving/treated mice	Dose		Route of application	Micronuclcated polychromatic erythrocytes (%)
		mg/kg	mmole/kg
Zinc sulphate	3/4	2 X 86.3	2 X 0.3	i.p.	2.9
	4/4	2 X 57.5	2 X 0.2	i.p.	1.9
	4/4	2 X 28.8	2 X 0.1	i.p.	1.7
	4/4	0	0	i.p.	1.9

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Under the test conditions, test material was found to be non-mutagenic.

Executive summary:

A micronucleus test on mouse bone marrow was conducted to evaluate the mutagenic potential of the test material.

Male and female NMRI mice were used for the study. Feed and water were provided ad libitum. 4 animals (2 male, 2 female) were used in each treatment and control groups. 86.3, 57.5 and 28.8 mg/kg doses were administered i.p. at 0 and 24 h. Bone marrow smears were prepared at 30 h. 1000 polychromatic erythrocytes were scored per mouse. Significance was calculated according to the Kastenbaum-Bowman tables.

Under the test conditions, test material was found to be non-mutagenic.