Concentrates of lead and zinc compounds with sulfur resulting from hydrometallurgy (hot acid leaching, super-hot acid leaching and flotation)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Used in EU risk assessment for zinc sulphate, Study well documented, meets generally accepted scientific principles, acceptable for assessment.Read-across justification: Read-across from the most critical and bioavailable constituents (zinc and its compounds):The target substance is a solid inorganic UVCB substance and insoluble in water. Therefore, the transformation/dissolution study (OECD guidance 29) was conducted for the target substance to focus on the most critical bioavailable constituents of the substance. Based on the mineralogical composition, two major constituents of this target substance in addition to lead are zinc and sulphur. Zinc appears in sulphide form in the target substance. According to the 7-day and 28-day transformation/dissolution study at 100, 10 and 1 mg loadings (OECD guidance 29) zinc and sulphur are also soluble from the target substance. Since sulphur can appear either in sulphide or sulphate form in water, the read-across data focuses on the properties of zinc sulphate and other bioavailable forms of zinc. The read-across on zinc and its compounds are used in the chemical safety assessment for those endpoints where the adverse effects of the target substance can be affected by zinc content of the substance. The read-across data was justified in order to avoid unnecessary animal testing.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

No information

Author:

Litton bionetics

Year:

1974

Bibliographic source:

EU risk assessment report for zinc sulphate, 2004

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 sulphate

EC Number:

231-793-3

EC Name:

Zinc sulphate

Cas Number:

7733-02-0

Molecular formula:

H2O4S.Zn

IUPAC Name:

zinc sulfate

Details on test material:

- Name of test material: Zinc sulphate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

for more information refer to reference

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: suspended in 0.85% saline

Details on oral exposure:

animals were observed for 10 daysDOSAGE 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

Results and discussion

Effect levels

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

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated informationCriteria used for interpretation of results: EU

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.