Ammonium sodium vanadium oxide

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:

2006-05-30 to 2006-06-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

sodium trivanadium octaoxide

IUPAC Name:

sodium trivanadium octaoxide

Constituent 2

Reference substance name:

Sodium trivanadium octaoxide

EC Number:

234-709-3

EC Name:

Sodium trivanadium octaoxide

IUPAC Name:

234-709-3

Constituent 3

Reference substance name:

12026-08-3

Cas Number:

12026-08-3

IUPAC Name:

12026-08-3

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): "SODIUMPOLYVANADATE (SPV)"
- Chemical name: Sodiumpolyvanadate
- Molecular formula: Na2V6O16
- Physical state: auburn powder
- Stability at conditions of storage: stable
- Storage condition of test material: room temperature
- Water solubility: hardly soluble
- Stability in aqueous solutions: stable
- pH = 3.00 (1% suspension in deionised water, w/v, determined with a pH-Meter WTW pH 340)

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS - Crl:CD(SD)IGS BR
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: approximately 8 weeks at the time of the administration
- Weight at study initiation: 174 - 193 g
- Fasting period before study: the feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards
- Housing: single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Aspen wood chips, Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved.
- Diet (ad libitum): Altromin 1324 forte, gamma irradiated with 25 kGy 60Co (Producer: Altromin GmbH, D-32791 Lage)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week

ENVIRONMENTAL CONDITIONS
- Temperature: average 22.2°C (continuous control and recording)
- Relative humidity: average 53.0% (continuous control and recording)
- Air exchange: 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.1% aqueous solution of Na-carboxymethylcellulose plus Tween 80 (Polyoxyethylensorbitanmonooleate

Details on oral exposure:

VEHICLE
- a 0.1% aqueous solution of Na-carboxymethylcellulose ("CMC" high viscosity, item No. C-5013, Lot. No. 98H0328, Sigma) plus Tween 80 (Polyoxyethylensorbitanmonooleate, article No. 822187, Merck) was used as vehicle for the test substance.
- Justification for choice of vehicle: the test substance was not soluble in water. Aqueous CMC plus Tween 80 is a common vehicle for acute oral toxicity testing.

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
The individual dose volumes were calculated using the body weights determined on the day of the administration.

DOSAGE PREPARATION:
The test substance was administered as a suspension.
The suspensions were prepared freshly before administration and were administered within 10 minutes after the preparation.

CLASS METHOD
- Rationale for the selection of the starting dose: as no prior information on the toxicity of the test substance was available, a starting dose of 300 mg of the test substance per kg body weight was chosen.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 6 females (3 females per step)
2000 mg/kg bw: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 -2, 2 - 4 and 4 - 6 hours after administration of the test substance and then at least once a day for a total of 2 weeks.
Body weights were determined before administration as well as 7 and 14 days after administration and at death (early deaths: as soon as possible after finding; animals deceased on the day of administration were not reweighed). Body weight gain was calculated for each week of the study, i.e. between 0 and 7 days and 7 and 14 days after administration.
- Necropsy of survivors performed: yes, surviving animals were killed by inhalation of 80% CO2 + 20% air 14 days after administration and were also subjected to a necorpsy including a gross pathological examination.
Deceased animals were dissected and examined macroscopically in an attempt to identify the target organs.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

500 mg/kg bw

Based on:

test mat.

Mortality:

300 mg/kg bw: one female died per step (5 and 7 days after administration, respectively)
2000 mg/kg bw: all females died between 6 hours and 1 day after administration

Clinical signs:

other: All animals were affected. The findings, with an earliest onset shortly after the administration and lasting until death or to a maximum of 9 days after administration were: diarrhoea, exsiccosis and signs of reduced well-being (this term encompasses unsp

Gross pathology:

Abnormal findings were present only in deceased animals:
- glandular stomach, mucose, erosion or ulcers (300 mg/kg bw: 2 animals)
- stomach, blood in the lumen (300 mg/kg bw: 1 animals)
- small intestine, enteritis (2000 mg/kg bw: 3 animals)
- anus, soiled with faeces (300 mg/kg bw: 2 animals; 2000 mg/kg bw: 2 animals)
Shock from gastrointestinal lesions may have been the cause of death.
All other animals were normal at the necropsy 14 days after administration.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 is estimated to be 500 mg/kg bw in rats according to annex 2 of OECD 423.
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.