Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well documented, scientifically sound study with methods similar to OECD 401 with the following deviations: The number of deaths at each dose were not reported; the specific doses (mg/kg) were not provided; individual clinical observations, body weights, pathology were not reported; sex of the animals was not provided.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1950

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
The number of deaths at each dose were not reported; the specific doses (mg/kg) were not provided; individual clinical observations, body weights, pathology were not reported; sex of the animals was not provided
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): zirconyl acetate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult rats
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: no data
- Housing: maintained in air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
50% aqueous solutions were used.
Doses:
Single dose, no more data
No. of animals per sex per dose:
24 rats in total
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
Statistics:
The LD50 values were obtained from ten day mortality data by using the log-probability method.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 100 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 660 mg/kg bw
Based on:
element
Remarks:
Zr
Mortality:
The rats showed a progressive depression and decrease in activity until death occurred.
No sex differences were noted, and the LD50 value was therefore derived from the combined data on both sexes.
The time of death varied from a few hours to a few days after administration. Few deaths however occurred later than 5 days after administration.
Clinical signs:
No characteristic physiologic changes were observed.
Body weight:
No characteristic physiologic changes were observed.
Gross pathology:
No characteristic gross pathologic changes were observed.

Applicant's summary and conclusion

Conclusions:
The acute oral LD50 value in rats via oral gavage route is 4100 mg/kg bw (zirconyl acetate).