Ammonium sodium vanadium oxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

2006-06-20 to 2006-07-18

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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987-02-24

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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: at ambient temperature, in the dark
- Water solubility: hardly soluble
- Stability in aqueous solutions: stable

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS - CRL:CD(SD) BR SPF
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Age at study initiation: approximately 8 weeks (males) and 12 weeks (females) at the time of the administration
- Weight at study initiation: males: 253 - 276 g; females: 232 - 257 g
- Housing: single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids. Aspen wood chips, type "ABEDD", (Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach), autoclaved.
- Diet (ad libitum): Altromin 1324 forte (Producer: Altromin GmbH, D-32791 Lage) gamma irradiated with 25 kGy 60Co
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

A health inspection was performed prior to the commencement of treatment to ensure, that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: a single dermal administration was performed by spreading the test substance on an area of at least 10% of the estimated body surface.
The test site was located on the dorsal thoracal region. An area of 6.5 cm x 8 cm (52 cm^2) was marked on a relaxed animal.
The hair of the dorsal trunk was clipped with an electrical hair clipper (Aesculap GH, 0.1 mm cutter head) one day before application of the test substance.
- Type of wrap if used: a cellulose patch (Pehazell, Hartmann AG) with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape (Blenderm Wundpflaster, 3M).
Patch and tape were covered semi-occlusively by a dressing (Fixomull Stretch, Fa. Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was wiped off using wet cellulose tissue, if necessary.
- Time after start of exposure: at the end of the exposure period the dressing, the tape and the patch were removed.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the individual amounts of the test substance were calculated using the body weights determined on the day of the administration.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: observations were performed 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. 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, all animals were killed by inhalation of 80% CO2 + 20% O2 14 days after administration and subjected to a necropsy including a gross pathological examination.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

other: General findings: all animals were normal during the entire observation period. Observations of skin condition: a light brown staining of the skin was observed in all animals from day 1 until a maximum of day 5 after administration. This stain is attribut

Gross pathology:

All animals were normal at terminal necropsy.

Other findings:

- Other observations: no noteworthy sex difference in the response to the test substance was derived from clinical observations or post-mortem findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 (male and female rats) > 2000 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified.