Zinc sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Acute Zinc Intoxication: Comparison of the Antidotal Efficacy of Several Chelating Agents

Author:

Domingo J L, Llobet J M, Paternain J L and Corbella J

Year:

1988

Bibliographic source:

Vet Hum Toxicol 30(3):224-228

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(No data about doses, controls, observation frequency, fasting period before study, age at study initiation, housing of animals)

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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:

- Name of test material: Zinc sulphate
- Other: Source - E Merck (Darmstadt, FRG)

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Panlab (Barcelona, Spain)
- Age at study initiation: No data
- Weight at study initiation: 24-28 g
- Fasting period before study: No data
- Housing: No data
- Diet: Standard pellet diet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 d

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 0.2 mL/30 g body weight

DOSAGE PREPARATION: Solutions were administered at pH between 6.0 and 7.0. Sodium bicarbonate was used to adjust the pH when necessary.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A preliminary screening with small groups of 3 animals was carried out The LD50 values were then calculated according to the Litchfield and Wilcoxon method.

Doses:

No data

No. of animals per sex per dose:

Preliminary screening: Three
Final study: Ten

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations: No data
- Necropsy of survivors performed: No
- Other examinations performed: Clinical signs and weight gain

Statistics:

No data

Results and discussion

Preliminary study:

A preliminary screening with small groups of three animals was carried out. The LD50 values were then calculated according to the Litchfield and Wilcoxon method

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 926 mg/kg bw

95% CL:

>= 636 - <= 1 350

Remarks on result:

other: Equivalent to 337 mg of Zn/kg

Mortality:

Mortality occurred mostly during the first 48 h of the test material administration. No deaths occurred after three days.

Clinical signs:

other: Conjunctivitis, piloerection, asthenia, decreased food and water consumption and hemorrhages and hematomas in the tail were observed. See Table 1 in "Remark on results including tables and figures" field.

Gross pathology:

No data

Other findings:

No data

Any other information on results incl. tables

Table 1. Severity of physical and clinical signs in mice after zinc intoxication in a single dose

	Number of days after zinc administration
	1	2-3	4-7	8-14
Mortality rates on oral administration	90%	10%	0%	0%
Conjunctivitis	None	+	+	None
Piloerection	None	+	+	+
Hemorrhages and hematomas in the tail	None	+	+++	+++
Asthenia	++	++	+	None
Degreased food and water consumption, weight loss	None	+	+	None

Mortality rates and physical and observational examination of rats are average for all zinc compounds.

+Light; ++Moderate; +++Severe

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the above results, the acute oral LD50 of the test material in Swiss albino mice was determined to be 926 mg/kg (equivalent to 337 mg of Zn/kg).

Executive summary:

A study was conducted to evaluate the acute oral toxicity of the test material in Swiss albino mice according to the OECD Guideline 401 (Acute Oral Toxicity).

Initially a preliminary screening with small groups of three mice was carried out and the LD50 values were then calculated according to the Litchfield and Wilcoxon method. The main study was conducted with ten mice.

Mortality occurred mostly during the first 48 h of the test material administration. No deaths occurred after three days. Conjunctivitis, piloerection, asthenia, decreased food and water consumption and severe hemorrhages and hematomas in the tail vein were observed in the treated mice.

Based on these results, the acute oral LD50 was calculated to be 926 mg/kg (equivalent to 337 mg of Zn/kg).