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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2001-07-09 to 2001-08-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented, scientifically sound study performed according to OECD Guideline 401; however, environmental conditions were not provided in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granules
Details on test material:
- Name of test material (as cited in study report): Zirconia Powder
- Physical state: white granules
- Stability under test conditions: no data
- Storage condition of test material: stored in a dark place at room temperature

Test animals

Species:
rat
Strain:
other: Crj: CD (SD) IGS rats (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan, Inc.
- Age at study initiation: 5 weeks
- Weight at study initiation: 115.7 - 127.5 g for males and 101.9 - 111.7 g for females
- Fasting period before study: overnight before the administration, and for 3-4 hours after the administration
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: 2001-07-19 To: 2001-08-02

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: purified water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): SEJI1860, Wako Pure Chemical Co., Ltd and A116, Takasugi Pharmaceutical Co., Ltd (purified water)
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): The test substance was weighted accurately and ground to a fine powder. The powder was mixed with a suitable amount of arabic gum and purified water. The rest of the arabic gum was added as a solution to obtain a 20.0 w/v % suspension.

The animals were put on fasting overnight before the administration, and for 3-4 hours after the administration. The administration was done in the morning by single dose forced oral administration using Nelaton catheter (Terumo Corporation) and a syringe (Terumo Corporation).

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed all the samples frequently for up to 6 hours after the administration, then once a day for the next 14 days. All samples were weighed right before the administration, then 1, 3, 7, 14 days after the administration.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and macroscopic examination
Statistics:
The mean value and the standard deviation of the body weight were calculated in each group.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No abnormalities were noted in all groups.
Clinical signs:
No abnormalities were noted in all groups.
Body weight:
No abnormalities were noted in all groups.
Gross pathology:
No abnormalities were noted in all groups.
Other findings:
no data

Applicant's summary and conclusion

Conclusions:
The LD50 of zirconium oxide is higher than 2000 mg/kg body weight by oral route in the rat.