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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2001-02-13 to 2001-03-28
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.

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Yttrium zirconium oxide
EC Number:
264-885-7
EC Name:
Yttrium zirconium oxide
Cas Number:
64417-98-7
Molecular formula:
(ZrO2)x (Y2O3)y 0.59 < x < 1.0 and 0 < y < 0.41
IUPAC Name:
Yttria-Stabilised Zirconia
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): zirconium oxide
- Composition: zirconium oxide containing yttrium oxide intercrystallised
- Physical state: white powder
- Stability under test conditions: stability to water and other solvent, heat, light, etc.
- Storage condition of test material: room temperature (10~30 degrees C)
- Further details on test material confidential

Test animals

Species:
rat
Strain:
other: Crj: CD (SD) IGS rat (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 5 weeks
- Weight at study initiation: 103.9-113.6 g for males and 89.0-101.2 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: 2001-02-20 To: 2001-03-06

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): A113; Takasugi Pharmaceutical Co., Ltd
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): 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 flexible catheter (Terumo Corporation) and syringes (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 day to 14 days after the administration. 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 autopsy
Statistics:
For weight, the average and the standard deviation were calculated for males and females of each group.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths in either male or female animals.
Clinical signs:
Ash gray stools were observed 1 day after the administration, but they disappeared in 2 days. The ash grey stools seen were considered to be a change resulting from the color of the test agent since it was white, and toxicological significance is considered to be low.
Body weight:
No abnormality was seen in either males or females.
Gross pathology:
No abnormality was seen in either males or females.
Other findings:
no data

Applicant's summary and conclusion

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