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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: Non-GLP non-guideline animal experimental study, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity of zirconium, columbium, strontium, lethanum, cesium, tantalum and yttrium.
Author:
Cochran, K.W., Doull, J., Mazur, M. and DuBois, K.P.
Year:
1950
Bibliographic source:
Arch. Ind. Hyg. Occ. Med., 1(6), 637-650 (1950)

Materials and methods

Principles of method if other than guideline:
In this acute oral toxicity study 24 adult Sprague Dawley rats (both sexes) were used. The animals received single 50% aqueous zirconyl acetate solutions orally by stomach tube. All animals were observed for ten days, but initial groups receiving a given compound were kept for thirty days to ascertain whether any significant mortality occurred after the tenth day. The LD50 values were obtained from ten day mortality data by using the log-probability method.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Zirconium di(acetate) oxide
EC Number:
225-924-3
EC Name:
Zirconium di(acetate) oxide
Cas Number:
5153-24-2
Molecular formula:
C4 H6 O5 Zr
IUPAC Name:
zirconium di(acetate) oxide
Details on test material:
No details given

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult rats
- Weight at study initiation: 200-300 gram
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
animals were maintained in airconditioned rooms

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% aqueous solutions.
Doses:
No details given.
No. of animals per sex per dose:
24 rats (no details on the number of males and females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: all animals were observed for 10 days, but initial groups receiving a given compound were kept for 30 days to ascertain whether any significant mortality occurred after the 10th day. It was found that 10-day observation periods were sufficient since animals either succumbed or recovered during this period.
- Other examinations performed: physiology and gross pathology
Statistics:
The LD50 values were obtained from ten day mortality data by using the log-probability method.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No sex differences were noted in the degree to which rats were susceptible to the substance investigated. LD50 values were therefore derived from the combined data on both sexes.
Mortality:
The time of death varied from a few hours to a few days following the administration of the compound. Few deaths however occurred later than five days after administration of zirconium salts.
Clinical signs:
Progressive depression and decrease in activity until death occurred.
Body weight:
No details given
Gross pathology:
No characteristic gross pathologic changes were observed.

Applicant's summary and conclusion