Registration Dossier
Registration Dossier
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EC number: 231-943-8 | CAS number: 7779-88-6
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:
- migrated information: read-across based on grouping of substances (category approach)
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
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:
- 1 981
- 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
- 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)
Constituent 1
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.
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