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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles.
Cross-reference
Reason / purpose:
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:
OECD Guideline 401 (Acute Oral Toxicity)
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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 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:
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 sensitivity to pain.
Most clinical and physical signs appeared within 24 hours, and most of them disappeared 48 hours after the administration of the vanadium compound.
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (male rats): 448 mg/kg bw (vanadium oxide sulfate pentahydrate)
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is classified as harmful if swallowed.
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-Commission directive 67/548/EEC and its subsequent amendments, the test substance is classified as harmful if swallowed.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is classified as Category 3.