Zinc sulphate

Endpoint summary

Description of key information

Assessment of the acute oral toxicity of zinc sulphate was studied in Sprague-Dawley or Wistar rats and Swiss mouse according to OECD guideline no 401 or 423. Soluble zinc sulphate (monohydrate, hexahydrate and heptahydrate) has LD50 oral values ranging from 574 to 2,949 mg/kg bw, 862 to 4,429 mg/kg bw and 920 to 4,725 mg/kg bw, respectively for the three forms of zinc sulphate. Effects of inhalation exposure to zinc sulphate were limited to pulmonary effects only. Assessment of acute dermal toxicity was studied on the skin of Wistar rats at 2000 mg/kg bw for 24 hours (OECD guideline no 402) demonstrating zinc sulphate is not acutely toxic via the dermal route (LD50 >2,000 mg/kg bw)

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:

supporting 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

Remarks:

Used in EU risk assessment for zinc sulphate

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

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

for more information refer to reference

Route of administration:

oral: gavage

Vehicle:

other: suspended in 0.85% saline

Details on oral exposure:

animals were observed for 10 days


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:

50 , 100, 500, 1000 and 3000 mg/kg

No. of animals per sex per dose:

5 animals per dose

Control animals:

not specified

Details on study design:

see reference

Statistics:

No data

Sex:

male

Dose descriptor:

LD50

Effect level:

920 mg/kg bw

Mortality:

no information

Clinical signs:

other: see reference

Gross pathology:

reddened stomach and intestinal mucosa

Other findings:

No data

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 is 920 mg/kg bw

Executive summary:

In an acute oral study zinc sulphate (type not specified, only “Zinc sulphate, Rayon”) was suspended in 0.85% saline and administered to male Sprague Dawley rats by intubation. Dose levels were 50, 100, 500, 1000 and 3000 mg/kg (5 animals per dose). Animals were observed for ten days. Toxicity signs were reddened stomach and intestinal mucosa. The LD₅₀value was determined as 920 mg/kg bw zinc sulphate.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

574 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Used in EU risk assessment report for zinc sulphate

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

not specified

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

Details on study design:

observation period of 15 days

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: no effects

Gross pathology:

no effects

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 dermal is >2000 mg/kg bwZinc sulphate is not harmful or toxic via the dermal route

Executive summary:

In this study zinc sulphate heptahydrate was administered to the skin of five Wistar rats of each sex at 2000 mg/kg bw for 24 hours. Animals were observed for 15 days. Clinical signs of toxicity consisted of erythema (grade 1 and 2, of maximum grade 4), scales and/or scabs (scale 1 and 2, of maximum scale 3) in the treated skin area between observation days 2-8.

Zinc sulphate is not harmful or toxic via the dermal route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Soluble zinc sulphate (monohydrate, hexahydrate and heptahydrate) has LD₅₀oral values ranging from 574 to 2,949 mg/kg bw, 862 to 4,429 mg/kg bw and 920 to 4,725 mg/kg bw, respectively for the three forms of zinc sulphate. Zinc sulphate is not acutely toxic via the dermal route (LD50 >2,000 mg/kg bw). Effects of inhalation exposure to zinc sulphate were limited to pulmonary effects only.

Justification for selection of acute toxicity – oral endpoint
Lowest LD50 value.
zinc sulphate (monohydrate, hexahydrate and heptahydrate) has LD50oral values ranging from 574 to 2,949 mg/kg bw, 862 to 4,429 mg/kg bw and920 to 4,725 mg/kg bw, respectively for the three forms of zinc sulphate

Justification for classification or non-classification

Soluble zinc sulphate (monohydrate, hexahydrate and heptahydrate) has LD₅₀oral values ranging from 574 to 2,949 mg/kg bw, 862 to 4,429 mg/kg bw and 920 to 4,725 mg/kg bw, respectively for the three forms of zinc sulphate and is classified as harmful if swallowed (Acute Tox.Cat.4: H302 ) according EC criteria. Zinc sulphate is not acutely toxic via the dermal route (LD50 >2,000 mg/kg bw). Effects of inhalation exposure to zinc sulphate were limited to pulmonary effects only.