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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
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The micronucleus test was performed according to Schmid [51]. The animals were treated at 0 and 24 h, and bone-marrow smears were prepared at 30 h. Usually, 4 mice (2 male, 2 female) were used for each of 3 doses and 1 control. Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse. Significance was calculated according to the Kastenbaum-Bowman tables

51] Schmid, W., The micronucleus test for cytogenetic analysis, in: A. Hollaender (Ed.), Chemical Mutagens, Vol. 4, Plenum, New York, 1976, pp. 31-53.
GLP compliance:
not specified
Type of assay:
other: mammalian somatic cell study

Test material

Constituent 1
Chemical structure
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:
Source: Merck Co., Darmstadt (Germany);

Test animals

Species:
mouse
Strain:
NMRI
Details on species / strain selection:
Source: S. Ivanovas GmbH and Co., Kisslegg/Allgäu (Germany)
diet: ad libitum, standard chow (Altromin GmbH, Lage, Germany)
water. ad libitum
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
Bone-marrow smears were prepared at 30 h.
Frequency of treatment:
The animals were treated at 0 and 24 h.
No. of animals per sex per dose:
Usually, 4 mice (2 male, 2 female) were used for each of 3 doses and 1 control.
Control animals:
yes, plain diet

Examinations

Tissues and cell types examined:
Polychromatic erythocytes
Details of tissue and slide preparation:
Bone-marrow smears were prepared at 30 h.
Evaluation criteria:
not specified
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:
not applicable
Negative controls validity:
valid
Positive controls validity:
not examined

Any other information on results incl. tables

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

Compound surviving/treated mice Dose  
mg/kg mmole/kg Route of application Micronucleated PEa(‰)
Zinc sulfatec 3/4 2x86.3 2x0.3 i.p. 2.9
  4/4 2x57.5 2x0.2 i.p. 1.9
  4/4 2x28.8 2x0.1 i.p. 1.7
  4/4 0   i.p. 1.9
           
aPolychromatic erythocytes
c
Hanks' balances salt solution (HBSS)
 

Applicant's summary and conclusion

Conclusions:
Zinc sulfate showed no genetic activity in the micronucleus test.
Executive summary:

The in vivo micronucleus test on mouse bone marrow was performed according to Schmid and international standard methods. The animals were treated at 0 and 24 h with zinc sulfate, and bone-marrow smears were prepared at 30 h. Usually, 4 mice (2 male, 2 female) were used for each of 3 doses and 1 control. Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse. Significance was calculated according to the Kastenbaum-Bowman tables.

Zinc sulfate showed no genetic activity in the micronucleus test.

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