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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The acute, chronic and topical toxicity of zirconium carbonate.
Author:
Harrison, J.W.E., Trabin, B., Martin, E.W.
Year:
1951
Bibliographic source:
Journal of Pharmacology and Experimental Therapeutics 102, 179-184

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
9-week exposure of kittens via the diet
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
EC Number:
260-633-5
EC Name:
[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
Cas Number:
57219-64-4
Molecular formula:
CH2O7Zr2
IUPAC Name:
[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Name of test material (as cited in study report): hydrated zirconium carbonate
- Molecular formula (if other than submission substance): 3ZrO2.CO2.H2O
- Physical state: water insoluble moist paste
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: containing 20.9 % ZrO2

Test animals

Species:
cat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: kittens
- Weight at study initiation: 600 g
- Fasting period before study: no data
- Housing: kittens at the same dosage level were housed together
- Diet (e.g. ad libitum): normal diet
- Water (e.g. ad libitum): normal diet
- Acclimation period: acclimitazed

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
2 groups of 3 kittens each were fed during 9 weeks with a mixture of kitten diet and hydrated zirconium carbonate (HZC) at 1 and 5% (w/w).
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
9 weeks
Frequency of treatment:
continuously in the diet
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
1% (w/w)
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
5% (w/w)
Basis:
nominal in diet
No. of animals per sex per dose:
1 male and 2 females
Control animals:
yes, plain diet
Details on study design:
Kittens were distributed as litter mates throughout the dosage levels.
Positive control:
No positive control

Examinations

Observations and examinations performed and frequency:
Kittens were weighed weekly, observed daily and autopsied at the end of the 9 weeks
Sacrifice and pathology:
Gross pathology
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
Each kitten consumed ca. 7250 g of food during the 9-week period. This corresponds to an intake of 72 g and 372 g of HZC per kitten in the respective dosage groups. The weight gain was normal. All animals were healthy and at autopsy nothing abnormal was encountered.

Effect levels

Dose descriptor:
NOAEL
Effect level:
372 other: g/animal
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: The NOAEL is based on the total compound intake during the 9 week period.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Ingestion of equivalent cumulative doses of 72 and 372 g of hydrated zirconium carbonate for a period of 9 weeks does not cause any deaths in the 6 kittens exposed during the test. This indicates the absence of toxic effects of HZC when ingested over a prolonged period of time and confirms the results obtained in rats.