Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No abnormalities were detected.
Body weight:
Body weight gains were acceptable. Body weight gain after 14 days: 129 +/- 17 g in males and 67 +/- 12 g in females.
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.