Vanadium zirconium yellow baddeleyite

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-02-29 to 2000-03-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996-03-22

Deviations:

yes

Remarks:

rationale for the selection of the starting dose was missing.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Vanadium zirconium yellow baddeleyite

EC Number:

269-063-1

EC Name:

Vanadium zirconium yellow baddeleyite

Cas Number:

68187-01-9

Molecular formula:

V(x)Zr(1-x)O2 0,01≤x≤0,12

IUPAC Name:

divanadium(5+) zirconium(4+) heptaoxidandiide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Vanadium-Zirconium Yellow
- Substance type: inorganic pigment
- Physical state: yellow powder
- Storage condition of test material: at room temperature in the dark
- Stability in water: at least 96 hours

Specific details on test material used for the study:

- Stability in vehicle (propylene glycol): at least 96 h

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS - Wistar strain Crl:(WI) BR (outbred, SPF-Quality)
- Age at study initiation: young adult animals (approx. 10 weeks old)
- Weight at study initiation: males: 215 h - 241 g; females: 298 g - 365 g
- Fasting period before study: food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3 -4 hours after administration of the test substance.
- Housing: group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Diet (ad libitum): standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium).
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

A health inspection was performed prior to commencement of treatment, to ensure that the animals were in good state of health.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Relative humidity: 30 - 70 %
- Air changes: approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: the vehicle was selected based on a pretest performed at NOTOX
- Specific gravity: 1.036

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION: the formulation was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of vehicle.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males / 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/viability: twice daily
Body weights: days 1 (pre-administration), 8 and 15.
Clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
- Necropsy of survivors performed: yes; at the end of the observation period, all animals were sacrificed by asphyxiation using an oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.

Statistics:

not applicable

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Lethargy (3/3 f), hunched posture (3/3 f), uncoordinated movements (3/3 f), piloerection (2/3 f) and/or ptosis (1/3 f) were noted among all females between days 1 and 6. In males, no clinical sings were noted.

Gross pathology:

No abnormalities were found at macroscopic post maritime examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (male and female rats) > 2000 mg/kg bw
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.