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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A scientifically defensible approach was used to conduct the study performed similar to OECD 423 guideline. No data on GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
Remarks:
(No data on control animals)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
5970-45-6
Cas Number:
5970-45-6
IUPAC Name:
5970-45-6
Constituent 2
Reference substance name:
Acetic acid, zinc salt, hydrate (2:1:2)
IUPAC Name:
Acetic acid, zinc salt, hydrate (2:1:2)
Details on test material:
- Name of test material (as cited in study report): Zinc acetate dihydrate
- Molecular formula (if other than submission substance): C4-H6-O4.Zn.2H2-O
- Molecular weight (if other than submission substance): 219.48
- Substance type: discrete
- Physical state: solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: The animals were supplied by Panlab (Barcelona, Spain).
- Weight at study initiation: 230-280 g
- Diet (e.g. ad libitum): The animals had free access to a standard pellet diet (Panlab, Barcelona, Spain).
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: Rats were allowed to acclimatize for a period of 7 days after shipping before experimental use.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Details on oral exposure:
Solutions of zinc were prepared and administered in 0 .9% saline.
Solution concentrations were adjusted so that a 300-g rat received 1 mL.
All solutions were given at pH between 6.0 and 7.0. Sodium bicarbonate was used to adjust the pH when necessary.
Doses:
No data.
No. of animals per sex per dose:
Ten male animals in each group were used.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
The LD50 values were then calculated according to the Litchfield and Wilcoxon method.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
663.83 mg/kg bw
Based on:
test mat.
95% CL:
488.26 - 902.94
Remarks on result:
other: (Estimated results for Zinc Acetate anhydrous)
Mortality:
The majority of deaths were observed within the first 24 hr. No deaths occurred after 3 days.
Clinical signs:
other: The physical and clinical signs appeared within the first 48 hr. These signs included miosis, conjunctivitis, decreased food and water consumption and hemorrhages and hematomas in the tall. These changes decreased with time which would suggest a quick eli

Any other information on results incl. tables

The LD50 of zinc acetate anhydrous was 663.83 (488.26-902.94) mg/kg bw in male rats.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of zinc acetate anhydrous was 663.83 (488.26-902.94) mg/kg bw in male rats.
Executive summary:

Zinc acetate dihydrate was administered po by gavage to male rats. Ten animals in each group were used. The LD50 values were then calculated according to the Litchfield and Wilcoxon method. Animals were observed for 14 days.

The LD50 of zinc acetate anhydrous was 663.83 (488.26-902.94) mg/kg bw in male rats.

The majority of deaths occurred during the first 48 hr. The clinical and physical signs appearing after intoxication included miosis, conjunctivitis, decreased food and water consumption and hemorrhages and hematomas in the tall. These changes decreased with time which would suggest a quick elimination of zinc.