Zirconium oxide sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 20 February 2013 to 7 March 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented GLP study in accordance with OECD Guideline 402 with no deviations. A maximal reliability score of 2 (reliable with restrictions) was assigned because the study was used for read across purposes in this dossier.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium acetate

EC Number:

231-492-7

EC Name:

Zirconium acetate

Cas Number:

7585-20-8

IUPAC Name:

zirconium(2+) diacetate

Test material form:

other: aqueous solution

Details on test material:

- Name of test material (as cited in study report): Zirconium acetate solution
- Substance type: Colourless, clear, free-flowing, light solution
- Physical state: liquid
- Analytical purity: > 99%
- Composition of test material, percentage of components: aqueous solution containing 40.7% zirconium acetate anhydrous
- Purity test date: 30 August 2012
- Lot/batch No.: 12/228
- Expiration date of the lot/batch: August 2013
- Storage condition of test material: ambient conditions

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 176 to 200 grams
- Fasting period before study: none
- Housing: Polysulphone solid bottomed cages measuring 59.5x38x20 cm (during acclimatisation) and 42.5x26.6x18.5 cm (during the study) with nesting material provided into suitable bedding bags
- Diet (e.g. ad libitum): Ad libitum throughout the study
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 15 to 20/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 x 7 cm on dorsal surfaces of the trunk
- % coverage: 10% of body surface
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 2000 mg/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily for mortality and morbidity, day -1, 1, 8 and 15 for body weight and day of dosing (on dosing, approximately 1, 2 and 4 hours after dosing) and daily thereafter for 14 days for clinical signs
- Necropsy of survivors performed: yes (day 15): carbon dioxide narcosis; necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the treatment site).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

other: anhydrous zirconium acetate

Mortality:

No mortality occurred in male or female animals following treatment.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No significant abnormalities were found at necropsy examination performed on all animals at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

These results indicate that the test item has no systemic toxic effects in rats following dermal exposure over a 24 hour period at a level of 2000 mg/kg of zirconium acetate. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.