Ammonium trivanadium octaoxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-06-20 to 2006-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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 February 1987

Deviations:

no

GLP compliance:

yes

Remarks:

The study report states that the study meets the requirements of the Principles of GLP of the OECD (Environment Health and Safety Publications, Series on Principles of GLP and Compliance Monitoring No. 1, Paris 1998.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium trivanadium octaoxide

EC Number:

235-384-0

EC Name:

Ammonium trivanadium octaoxide

Cas Number:

12207-63-5

Molecular formula:

NH4V3O8

IUPAC Name:

trivanadium(5+) ammonium octaoxidandiide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Ammoniumpolyvanadate
- Physical state: yellow powder
- Stability under test conditions: stable
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Age at study initiation: approx. 8 weeks (males) and 12 weeks (females) at the time of administration
- Weight at study initiation: within the range of 223-246 g for females; within the range of 311-322 g for males
- Fasting period before study:
- Housing: Single caging in Makrolon cages type III (39 cm X 23 cm X 18 cm). Wire mesh lids. Bedding material: 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 kGy60Co
- Water (ad libitum): tap water
- Acclimation period: at least 5 days


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

Health conditions: 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.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
A single dermal administration was performed by spreading the test substance on an area of at least 10 % of the estimated body surface: The body surface was calculated using the formula: body surface (cm^2) = 10 X body weight (g)2/3. .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, 01 mm cutter head) one day before application of the test substance. 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-occlusiely by a dressing (Fixomull Stretch, Fa. Beiersdorf).

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

TEST MATERIAL
- Amount(s) applied: 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:

400 (females), 894 (females), 2000 (females and males) mg/kg bw

No. of animals per sex per dose:

5 females / 5 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation were performed 0 - 0.5, > 0.5-1, > 1- 2, > 2-4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 2 weeks. No skin examination of the administration site was possible during the exposure period, while it was covered by the patch and wrappings. Body weight were determined before administration, 7 days p.a. and 14 days p.a.. Body weight gain was calculated for each week of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations included but were not limitd to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions. All animals were killed by inhalation of 80 % CO2 + 20 % O2 14 days p.a. and subjected to a necropsy including a gross pathological examination.

Statistics:

not stated

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived until the scheduled termination of the study. No local or systemic test substancee related effects were noted at clinical observations or post-mortem examination at a dose of 2000 mg/kg b.w.

Clinical signs:

other: General findings: All animals were normal during the entire observation period. Observations of skin condition: A yellow staining of the skin was observed in all animals from 1 d until a maximum of 5 d p.a. This stain is attributed to a staining property

Gross pathology:

All animals were normal at terminal necropsy.

Other findings:

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

Any other information on results incl. tables

It has to be pointed out, that in the separately performed dose finding study, mortality occured at a dose of 2000 mg/kg (1 female & 1 male animals were tested and died). However, none of the 5 male and 5 female rats in the main test were affected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No local or systemic test substancee related effects were noted at clinical observations or post-mortem examination at a dose of 2000 mg/kg bw.
No classifiaction of "ammonium trivanadium octaoxide" is derived from the results of this study according to REGULATION (EC) No 1272/2008.