Ammonium zinc chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting 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

Data waiving:

other justification

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1988

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 chloride

EC Number:

231-592-0

EC Name:

Zinc chloride

Cas Number:

7646-85-7

IUPAC Name:

zinc dichloride

Details on test material:

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

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: 230-280 g
- Fasting period before study: No data
- Housing: No data
- Diet: Standard pellet diet (Panlab, Barcelona, Spain), 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): 1 mL/300 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 of each kind 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
Main study: Ten

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: 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 of each kind 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:

1 100 mg/kg bw

95% CL:

661 - 1 830

Remarks on result:

other: Equivalent to 528 mg of Zn/kg

Mortality:

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

Clinical signs:

Miosis, conjunctivitis and hemorrhages and hematomas in the tail.
For details see Table 1 in "Remark on results including tables and figures" field

Body weight:

Slight weight loss

Gross pathology:

No data

Other findings:

No data

Any other information on results incl. tables

Table 1. Severity of physical and clinical signs in rats 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%
Miosis	+	++	++	+
Conjunctivitis	+	++	+	None
Erythema, necrosis in nose	None	++	++	++
Exophthalmos	None	None	None	None
Degreased food and water consumption, weight loss	None	+	+	None
Hemorrhages and hematomas in the tail	None	++	++	+

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

+Light; ++Moderate

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute oral LD50 of the test material in Sprague-Dawley rats was calculated to be 1,100 mg/kg (equivalent to 528 mg of Zn/kg).

Executive summary:

A study was conducted to evaluate the acute oral toxicity of the test material in Sprague-Dawley rats according to the OECD Guideline 401 (Acute Oral Toxicity).

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

Miosis, conjunctivitis, decreased consumption of food and water and hemorrhages and hematomas in the tail were observed in the rats.

Under the test conditions, the acute oral LD50 of the test material in Sprague-Dawley rats was calculated to be 1,100 mg/kg (equivalent to 528 mg of Zn/kg).