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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
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 and Wild D
Year:
1981
Bibliographic source:
Mutat. Res. 90: 91-109

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
X-linked recessive lethal mutations were examined in Drosophila melanogaster upto F3 generations to evaluate the mutagenic potential of the test material.
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Constituent 1
Reference substance name:
Zinc sulphate
EC Number:
231-793-3
EC Name:
Zinc sulphate
Cas Number:
7733-02-0
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:
Drosophila melanogaster
Strain:
other: Berlin K (wild-type) and Basc
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: feed
Vehicle:
- Vehicle(s)/solvent(s) used: no data
Details on exposure:
DIET PREPARATION
- Mixing appropriate amounts with (Type of food): 5 % saccharose
Duration of treatment / exposure:
3 successive broods
Frequency of treatment:
No data
Post exposure period:
No data
Doses / concentrations
Remarks:
Doses / Concentrations:
5 mM
Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
yes
Positive control(s):
Trenimon

Examinations

Tissues and cell types examined:
X-chromosomes
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: Dose close to LD50 was selected for the study
Evaluation criteria:
No data
Statistics:
Significance was calculated according to the Kastenbaum-Bowman tables.

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
RESULTS OF DEFINITIVE STUDY
- Statistical evaluation: A significant (P < 0.01) increase of sex-linked recessive lethals was observed in the Basc strain in only one test, whereas non-significant results were observed in two repeats. It has been assumed that the single increased value was due to chance.

Any other information on results incl. tables

Table 1 : Results of the Basc test in Drosophila Melanogaster

Compound

Expt. no.

Conc. (mM)

Sex-linked recessive lethals/chromosomes tested and percentage

Brood 1

Brood 2

Brood 3

Zinc sulphate

 -

5

13/1206** (1.08)

2/1217 (0.16)

4/1200 (0.33)

 -

5

2/1233 (0.16)

2/1175 (0.17)

8/1193 (0.67)

 -

5

3/1185 (0.25)

1/1215 (0.08)

1/1023 (0.10)

 

 

18/3624* (0.50)

5/3607 (0.14)

13/3416 (0.38)

Controls (cumulated)

6

 -#

19/7130 (0.27)

8/5525 (0.14)

19/4871 (0.39)

Positive control (trenimon)

1

0.005

35/682** (5.13)

23/598** (3.85)

14/584** (2.40)

# Different solvents were used in separate controls,  *P ≤0.05, **P ≤0.01.

Applicant's summary and conclusion

Conclusions:
Under the test conditions, a single increased value observed was due to chance and did not indicate genotoxicity of zinc sulfate.
Executive summary:

A sex-linked recessive lethal test was conducted in Drosophila melanogaster to evaluate the mutagenic potential of zinc sulfate. Berlin K (wild-type) and Base strains were used for the study. 5mM test concentration (dose close to the LD50) was applied by the adult feeding method in 5% saccharose. Controls and positive control (trenimon) were also included. Appoximately 1200 X-chromosomes were tested in each of 3 successive broods (3-3-4 days). In repeat experiments, sometimes only single broods were tested. To confirm X-linked recessive lethal mutations, F2 progeny cultures with 2 or fewer wild-type males were routinely retested in the F3 generation. Mosaics were not counted. "Clusters" of 2 were included because their occurrence was compatible with statistical expectation of independent origin. Significance was calculated according to the Kastenbaum-Bowman tables. A significant (P < 0.01) increase of sex-linked recessive lethals was observed in the Basc strain in only one test, whereas non-significant results were observed in two repeats. Under the test conditions, a single increased value observed was due to chance and did not indicate genotoxicity of zinc sulfate (Gocke, 1981).