Vanadium oxide sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

Acceptable, well-documented publication which meets basic scientific principles.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Acute toxicity of vanadium compounds in rats and mice

Author:

Llobet, J. M. & Domingo, J. L.

Year:

1984

Bibliographic source:

Toxicology Letters, 23: 227 - 231

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981-05-12

Deviations:

yes

Remarks:

males only; body weight measurements and gross pathology not conducted

Principles of method if other than guideline:

Groups of 10 male Sprague-Dawley rats were given 296, 395, 500, 650, and 845 mg/kg of vanadyl sulfate pentahydrate (VOSO4 * 5H20) in 10 mM Tris-HCl-NaCl buffer (pH 7.4) by gavage. A control group receiving only the vehicle was also used during the study. The animals were observed for mortality and clinical signs during a 14 day observation period.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Vanadium oxide sulphate pentahydrate

Cas Number:

12439-96-2

Molecular formula:

VOSO4 x 5 H2O

IUPAC Name:

Vanadium oxide sulphate pentahydrate

Constituent 2

Reference substance name:

Vanadium oxide sulphate

EC Number:

248-652-7

EC Name:

Vanadium oxide sulphate

Cas Number:

27774-13-6

Molecular formula:

VOSO4

IUPAC Name:

oxovanadium(2+) sulfate

Constituent 3

Reference substance name:

12439-96-2

Cas Number:

12439-96-2

IUPAC Name:

12439-96-2

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): Vanadyl sulphate pentahydrate (from Merck (Darmstadt, FRG))
- Molecular formula (if other than submission substance): VOSO4 x 5H2O

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Biocentre (Barcelona, Spain)
- Weight at study initiation: 200 - 250 g
- Diet (ad libitum): Panlab diet
- Water (ad libitum): water

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Tris-HCl-NaCl buffer

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
Solution concentrations were adjusted so that a 250 g rat received 1 mL.

DOSAGE PREPARATION:
The test material was dissolved in 10 mM Tris-HCl-NaCl buffer (pH 7.4)

To calculate the LD50 values, a preceding screening with small groups of two or three animals was carried out.

Doses:

296, 395, 500, 650, and 845 mg/kg

No. of animals per sex per dose:

10 males

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

The LD50 values were calculated according to the Litchfield and Wicoxon method.*

*Reference:
J.T. Kitchfield and F. Wilcoxon, A simplified method of evaluating dose-effect experiments. J. Pharmacol. Exp. Ther., 96 (1949) 99 - 113

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

448 mg/kg bw

Based on:

test mat.

95% CL:

>= 412.2 - <= 486.9

Remarks on result:

other: Dose level equivalent to 288.5 mg/kg bw of vanadium oxide sulfate (calculated from the data given in the publication); Dose level equivalent to 90.3 mg/kg bw vanadium (83.1 - 98.1; calculated)

Mortality:

The following relation between dosage and mortality in rats was seen (alive/tested):
296 mg/kg: 10/10
395 mg/kg: 6/10
500 mg/kg: 4/10
650 mg/kg: 3/10
845 mg/kg: 0/10
The majority of deaths were observed within the first 48 hours. Few deaths occurred between the second and the seventh days. No death occurred after 7 days.

Clinical signs:

other: The highest dosage of the vanadium compound caused intense diarrhoea, irregular respiration, increased cardiac rhythm and ataxia. The most noticeable physical signs observed were: decreased locomotor activity, paralysis of the hind legs and decreased sens

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 (male rats): 448 mg/kg bw (vanadium oxide sulfate pentahydrate)
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is classified as Category 4.

LD50 (male rats) = 288.5 mg/kg (vanadium oxide sulfate)(calculate from data of the pentahydrate)
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is classified as Category 3.