[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium

Acute Toxicity: oral

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:

Non GLP study. The study was conducted according to a method equivalent to the OECD 401 guideline without major deviations. However, no data on test conditions are reported. Follow-up of body weight was done weekly, however no individual animal data were reported.

Data source

Reference

Reference Type:

publication

Title:

The acute, chronic and topical toxicity of zirconium carbonate.

Author:

Harrisson JWE, Trabin B, Martin EW

Year:

1951

Bibliographic source:

J Pharmacol Exp Ther Jul; 102(3): 179-84

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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:

[({[Hydroxy(Oxo)Zirconio]Oxy}Carbonyl)Oxy]Zirconiumoylol

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
- Molecular weight (if other than submission substance): no data
- Smiles notation (if other than submission substance): no data
- InChl (if other than submission substance): no data
- Structural formula attached as image file (if other than submission substance): no data
- Substance type: no data
- Physical state: water insoluble moist paste
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 3ZrO2.CO2.H2O equivalent to 20.9 % ZrO2
- Isomers composition: not applicable
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not applicable
- Storage condition of test material: not applicable
- Other: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: 7 to 8 months old
- Weight at study initiation: 350 g (preliminary test), 180 g (second more extensive test)
- Fasting period before study: 24 hours
- Housing: all rats were housed individually
- Diet (e.g. ad libitum): normal diet
- 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: no data

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Details on oral exposure:

Each rat was individually supplied once with a mixture of cheese and hydrated zirconium carbonate (HZC), calculated to provide single doses equivalent to 2,4, 8 or 10 gZrO2/kg bw (respectively 9.6, 19.1, 38.3, 47.85 g/kg bw of HZC)

Doses:

2, 4, 8 or 10 gZrO2/kg bw (respectively 9.6, 19.1, 38.3, 47.85 g/kg bw of HZC)

No. of animals per sex per dose:

five adult rats were used per dose (preliminary study)
50 young adult male rats were used in a second more extensive acute test

Control animals:

yes

Details on study design:

- Duration of observation period following administration: all rats were observed for 60 days, during wich period they received a normal diet
- Frequency of observations and weighing: Their general condition was noted daily and they were weighed weekly, as a check against delayed effects
- Necropsy of survivors performed: yes
- Other examinations performed: gross necropsy

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 47 850 other: mg /kg bw

Based on:

test mat.

Mortality:

No deaths occurred during either the preliminary test with the group of 20 adult male rats or the more extensive test with 50 younger adult male rats.

Clinical signs:

other: All animals continued to grow at a normal rate. No significant differences were noted among the test groups and the controls indicating that the acute oral toxicity of the zirconium carbonate was very low.

Gross pathology:

Gross examination of the autopsied animals revealed nothing abnormal.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No deaths occured during either the preliminary test with the group of 20 adult male rats or the more extensive test with 50 younger adult male rats. All animals continued to grow at a normal rate and gross examination of the autopsied animals revealed nothing abnormal up to a dose of 47850 mg/kg bw (based on test material).