Zinc di(acetate)

Endpoint summary

Description of key information

Acute toxicity: oral: Weight of evidence: The estimated LD50 for Zinc Acetate anhydrous was 663.83-2460 mg/kg bw in rats, and it was 239.95 mg/kg bw in mice. Mice were more sensitive than rats. Test method similar to OECD guideline 423.
Acute toxicity: inhalation: Weight of evidence: The estimated LC50 for Zinc Acetate was between 6.49 and 58.04 mg/L. Read-across approach from experimental data on analogues Calcium Acetate and Zinc Stearate.
Acute toxicity: other routes: Supporting information: The LD50 for adult mice was 42 mg/kg bw, and for juvenile mice was 97.8-99.6 mg/kg bw. The LD50 of zinc acetate anhydrous was 90.29 (56.02 -229.91) mg/kg bw in male mice, and 135.44 (74.41 -244.13) mg/kg bw in male rats. Mice were more sensitive than rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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.

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

663.83 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The analogue Calcium Acetate which shares the same functional group with Zinc Acetate, also has comparable values for the relevant molecular properties for the acute inhalation toxicity endpoint.

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

Read-across approach from Letter of Access experimental data (study with a test method similar to OECD 403) on the analogue Calcium Acetate.

GLP compliance:

no

Test type:

other: read-across from an standard acute method with an analogue

Sex:

female

Dose descriptor:

LC50

Effect level:

> 6.49 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Other findings:

Based on the experimental results obtained with the analogue Calcium Acetate (LC 50 for female rats > 5.6 mg/L air) and the molecular weights, the read-across approach is applied and the LC50 for substance Zinc Acetate is calculated to be higher than 6.49 mg/L air under test conditions.

The analogue Calcium Acetate, which shares the same functional group with Zinc Acetate, also has comparable values for the relevant molecular properties. These properties are:
- a low log Pow value which is - 1.38 for Calcium Acetate and -1.28 for Zinc Acetate,
- a similar water solubility which is 1.0 g/mL at 25 ºC for Calcium Acetate and 434.78 g/L for Zinc Acetate at 25 ºC, and
- molecular weights which are 158.166 for Calcium Acetate and 183.497 for Zinc Acetate.

The LC50 for substance Zinc Acetate is calculated to be higher than 6.49 mg/L air under test conditions.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 for substance Zinc Acetate is calculated to be higher than 6.49 mg/L air under test conditions.

Executive summary:

Based on the experimental results (reported under the endpoint record 07.02.02_01 CaAc) obtained with the analogue Calcium Acetate (LC 50 for female rats > 5.6 mg/L air) and the molecular weights, the read-across approach is applied and the LC50 for substance Zinc Acetate is calculated to be higher than 6.49 mg/L air under test conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

6 490 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

ACUTE TOXICITY: ORAL:

Weight of evidence: Experimental results with Zinc Acetate dihydrate. Test method similar to OECD guideline 423.

The Acute Oral Toxicity test of Zinc acetate dihydrate was performed in Carworth-Wistar male rats. Single oral dose toxicity is estimated by the gastric intubation of groups of five non-fasted rats (concentration of solution intubated: 0.200 g test substance /mL water). The estimated LD50 for Zinc Acetate was 2.06 (1.34 -3.16) g/kg bw (2.46 g/kg bw for Zinc acetate dihydrate) in male rats.

Zinc acetate dihydrate was administered po by gavage to male mice and rats. Ten animals of each kind 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 239.95 (118.72 -486.58) mg/kg bw in male mice, and it was 663.83 (488.26-902.94) mg/kg bw in male rats. Mice were more sensitive than 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.

ACUTE TOXICITY: INHALATION:

Weight of evidence: Read-across approach from experimental results obtained with Calcium Acetate and Zinc Stearate.

Calcium acetate LC₅₀value for 4 hours exposition at rat (male and female) is higher than 5.6 mg/L.

Based on these experimental results and the molecular weights, the read-across approach is applied and the LC50 for substance Zinc Acetate is calculated to be higher than 6.49 mg/L air under test conditions.

In a study with albino rats, Zinc stearate was determined to be nontoxic by inhalation. The (1 h) LC50 was > 200 mg/L.

The read-across approach is applied and the LC50 for substance Zinc Acetate is calculated to be higher than 58.04 mg/L air under test conditions.

ACUTE TOXICITY: OTHER ROUTES:

Supporting information: Experimental data on Zinc Acetate and Zinc Acetate dihydrate.

The sex and age related responses to Zinc Acetate were investigated in mice. Male and female juvenile and adult ICR-mice were administered single intraperitoneal injections of test substance. The median lethal dose (LD50) was calculated 1, 3, 5, 7, and 14 days following administration. Nearly all deaths occurred by day seven, with few deaths occurring between 7 and 14 days. The LD50 for juveniles was two and one half times higher than for adults. The mortality ratios on days one and three were higher for adult females than adult males, but by day seven, the LD50 values for males and females were not significantly different in either adults or juveniles.

The LD50 for adult mice was 42 mg/kg bw, and for juvenile mice was 97.8-99.6 mg/kg bw.

Zinc acetate dihydrate was administered ip to male mice and rats. Ten animals of each kind 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 90.29 (56.02 -229.91) mg/kg bw in male mice, and 135.44 (74.41 -244.13) mg/kg bw in male rats. Mice were more sensitive than 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.

Justification for classification or non-classification

Based on the available data, the substance is classified as acute oral toxicity category 4 according to CLP Regulation (EC) no. 1272/2008.

LD50>2000mg/kg/bw and <300mg/kg/bw: acute oral toxicity category 4.

Inhalation: LC50>5 mg/L: non-classification