Vanadium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-08-05 to 2010-08-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study reliable without restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

, adopted 2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2009-11-12

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Vanadium

EC Number:

231-171-1

EC Name:

Vanadium

Cas Number:

7440-62-2

Molecular formula:

V

IUPAC Name:

vanadium

Details on test material:

- Name of test material (as cited in study report): Vanadium (metal powder)
- Producer: International Specialty Alloys, Inc., PO Box 5186, New Castle, PA 16105, U.S.A.
- Element: V
- Atomic weight: 50.94 g/mol
- Physical state: Solid, silver-grey powder (odourless)
- Analytical purity: > 99%
- Batch No.: E01062
- Expiration date of the batch: At least until 2013
- Storage condition of test material: Kept cool and dry in tightly sealed containers
- Melting point: 1929°C [Gestis database]
- Boiling point: 3380°C [Gestis database]
- Relative density: 6.11 [Gestis database]
- Water solubility: Practically insoluble [Gestis database]
No further information on the test material was stated.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 163 - 191 g
- Fasting period before study: Feeding was discontinued approx. 16 hours before administration.
- Housing: Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus).
- Diet: Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity: 55% ± 15% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: hydroxypropylmethylcellulose

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: The administration volume was 10 mL/kg b.w.

DOSAGE PREPARATION: Vanadium (metal powder) was suspended to the appropriate concentration in 0.8% aqueous hydroxypropylmethylcellulose (Methocel; batch no. 09 D14-N28, Fagron GmbH & Co., 22885 Barsbüttel, Germany).
No further information on the oral exposure was stated.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

1 dose level group of 6 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration.
During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: Yes
All animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded.
- Other examinations performed: Changes in weight were calculated and recorded.
No further information on the test material was stated.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: A single oral administration of 2000 mg vanadium (metal powder)/kg b.w. to female rats did not reveal any signs of toxicity. No clinical signs were observed.

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 (rats, females) >2000 mg/kg b.w.
According to the EC-Commission Directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions vanadium (metal powder) is non-toxic if swallowed, hence, no labelling is required.
Also, according to the EC Regulation 1272/2008 and subsequent regulations, the test material is not classified for acute oral toxicity.