Zirconium vanadium blue zircon

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study reliable without restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral 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:

Zirconium vanadium blue zircon

EC Number:

269-057-9

EC Name:

Zirconium vanadium blue zircon

Cas Number:

68186-95-8

Molecular formula:

(Zr, V)SiO4

IUPAC Name:

silicon(4+) vanadium(4+) zirconium(4+) hexaoxidandiide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Sicocer F Tuerkis 2504
- Physical state: powder, blue
- Storage condition of test material: room temperature
- Other: the sample appeared to be homogeneous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS - Wistar (CHBB:Thom, (SPF))
- Age at study initiation: young adult animals
- Weight at study initiation: males: 185 - 190 g; females: 177 - 184 g
- Fasting period before study: the animals were given no feed at least 16 hours before administration, but water was available ad libitum
- Housing: single housing; stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG); no bedding in the cages; sawdust in the waste trays
- Diet (ad libitum, except for fasting period as stated above): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS - the animals were housed in fully air-conditioned rooms.
- Temperature: range of 20 - 24 °C
- Relative humidity: range of 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Based on the physical and chemical characteristics of the test substance no pronounced acute oral toxicity was expected. Therefore a dose of 2200 mg/kg body weight had been chosen for the study.

VEHICLE
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10.00 mL/kg

DOSAGE PREPARATION: test substance formulation with aqua bidest. (form of administration: suspension); time of day of administration was in the morning

Doses:

2200 mg/kg (concentration 22.000 g/100 mL)

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights were determined shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
- Necropsy of survivors performed: yes; necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1% significance level

Mortality:

No mortality occurred.

Clinical signs:

other: Signs of toxicity have not been noted.

Gross pathology:

No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

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) > 2200 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.

According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.