Boric acid, zinc salt

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key 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

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:

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 PE^a(‰)
Zinc sulfate^c	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^cHanks' 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.