Zirconium oxide sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 6 February 1992 to 20 February 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well documented GLP study performed according to OECD and EEC Guidelines. Purity of the test substance is not specified. Mean relative humidity was slightly out of protocol requirements (protocol not available), however, this is not considered to have affected the integrity of the 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)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium oxide sulphate

EC Number:

263-372-5

EC Name:

Zirconium oxide sulphate

Cas Number:

62010-10-0

Molecular formula:

O16S2Zr5

IUPAC Name:

pentazirconium(4+) octaoxidandiide disulfate

Details on test material:

- Name of test material (as cited in study report): Zirconium Basic Sulphate
- Substance type: white powder
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: S350-T4
- Storage condition of test material: stored in the dark under ambient conditions
- Other: received at IRI on 10 January 1992
- Other: Sponsor of study: Magnesium Elektron Limited, Swinton, Manchester, UK

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Manston Road, Margate, Kent
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 154-197 g
- Fasting period before study: rats were deprived of food overnight prior to dosing and 4h post dosing.
- Housing: The rats were housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays, with 5 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20°C and 21°C
- Humidity (%): mean relative humidity was 37%. Mean relative humidity was outwith protocol requirements, however, this is not considered to have affected the integrity of the study.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5%

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently on the day of dosing and once daily for 14 days following dosing. They were weighed immediately prior to dosing, 7 days after dosing and at sacrifice at the end of the 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Mean and standard deviation used in body weight determinations.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single oral dose of Zirconium Basic Sulphate at a dose level of 5000 mg/kg to a group of 5 male and 5 female rats.

Clinical signs:

other: No abnormalities were detected.

Gross pathology:

No abnormalities were detected.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There were no deaths following a single oral dose of zirconium basic sulfate (5000 mg/kg test substance) administered to a group of 5 male and 5 female rats. The Median Oral Lethal Dose (LD50) in rats is therefore greater than 5000 mg/kg.