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Toxicological information

Genetic toxicity: in vivo

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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:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.