Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No clinical signs were observed.
Body weight:
The body weight changes were within the expected range for this species and age of animals at the end of the study.
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.