Registration Dossier

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Peer-reviewed publication, 1984, described in good detail

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity of vanadium compounds in rats and mice
Author:
J Llobet and J 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)
Version / remarks:
Males only
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Hydrated form used for testing.
Calculations made to consider effects of the water-free substance

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Buffered to pH 7.4
Details on oral exposure:
Buffered to ca pH 7 to avoid local corrosivity effects
Doses:
296, 395, 500, 650, and 845 mg/kg reported (hydrated material)
ca 207, 277, 350, 455 and 591 mg/kg of anhydrous material.
No. of animals per sex per dose:
10 males
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 290 mg/kg bw
Based on:
act. ingr.
Mortality:
The top dose of ca 590 mg/kg actives led to 10/10 mortality. Other dose levels showed reduced mortality and the lowest treatment level of 207 mg/kg had full survival.
Clinical signs:
The top dos caused ataxia, diarrhoea, irregular respiration and changes in cardiac rhythm.
Clinical and physical signs typically appeared within 24 hours, and in surviving animals, had resolved 48 hours after administration.
Body weight:
No details reported
Gross pathology:
Not reported

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Although precise details were not provided in the publication, the result allow for classification.
Further animal testing is not justified.
Only the rat data has been included in this summary.