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Toxicological information

Acute Toxicity: oral

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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:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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).