Zirconium, tetrakis(isobutyrato)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 15th to December 7 th, 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrakis(isobutyrato)zirconium

EC Number:

619-635-5

Cas Number:

12567-73-6

Molecular formula:

Hill formula: C16H28O8Zr CAS formula: C16H28O8Zr

IUPAC Name:

Tetrakis(isobutyrato)zirconium

Constituent 2

Reference substance name:

Zirconium, tetrakis(isobutyrato)- (8CI)

IUPAC Name:

Zirconium, tetrakis(isobutyrato)- (8CI)

Details on test material:

- Name of test material (as cited in study report): Zirkonium-tetrakis(isobutyrato)
- Physical state: solid
- Analytical purity: 97.4 % (complexometric titration)
- Impurities (identity and concentrations): By-products:
toluene: ca. 2.1 %.
iso-butyric acid: ca. 0.5 %.
- Lot/batch No.: 02/05 (HK1005)
- Expiration date of the lot/batch: September 2006
- Storage condition of test material: Ambient temperature. Tightly closed. Storage under a nitrogen atmosphere, as the substance reacts with water.

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)IGS BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: approx.8 weeks
- Weight at study initiation: 186 - 213 g
- Fasting period before study: the feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Housing: single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week
- Diet (e.g. ad libitum): Altromin 1324 forte, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.0 °C
- Humidity (%): Average of 47.6 %
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: the test substance was not soluble in water. Corn oil is a common vehicle for acute oral toxicity testing.

DOSE VOLUME APPLIED: 10 mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: as no prior information on the toxicity of the test substance was available, a starting dose of 300 mg of the test substance per kg body weight was chosen. The further proceeding was in accordance with the guideline/directive.

Doses:

Single administration, performed in the morning.
The dosing was performed sequentially to groups of 3 animals per step using a starting dose of 300 mg per kg body weight and 2000 mg per kg body weight as the second dose.
Step 1 and 2: 300 mg/kg bw
Step 3 and 4: 2000 mg/kg bw

No. of animals per sex per dose:

3 animals/step, 4 steps.
12 animals in total.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weights: before administration, 7 and 14 days after the administration
- Necropsy of survivors performed: yes, the animals were sacrificed and necropsied 14 days p.a., for gross pathological findings.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Clinical observations: were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

other: All animals were normal during the entire observation period.

Gross pathology:

All animals were normal at the necropsy 14 d p.a.

Any other information on results incl. tables

Findings in life and post mortem indicate no toxic effects present.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight. No mortality occurred.

Executive summary:

Oral acute toxicity: key study in rats, single administration: according to OECD-Guideline 423 and EU Method B.1 tris.

The aim of the study was to investigate acute toxic effects of the test substance after a single oral administration (by gavage) to rats. The dosing was performed sequentially to groups of 3 animals per step using a starting dose of 300 mg per kg body weight and 2000 mg per kg body weight as the second dose.

No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight. No mortality occurred. As a consequence, it can be stated that LD50 is > 2000 mg/kg body weight.