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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From 24 March 2013 to 29 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study in accordance with OECD Guideline 404, Test method B.4, EPA OPPTS 870.2500 with no deviations.

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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

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 corresponding to 527.7 mg/mL
- 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:
rabbit
Strain:
other: Rabbit, New Zealand White Specific Pathogen Free (SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Lecco), Italy
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: approximately 2 kg
- Housing: Polycarbonate/stainless steel cages measuring 65.3x65.3x45 cm with perforated NorylTM floor suspended over trays
- Diet (e.g. ad libitum): STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK; ad libitum throughout the study.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 15 to 20/h
- Photoperiod (hrs dark / hrs light): 12/12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Enough water to form a paste
- Concentration (if solution): 0.5 mL/animal
Duration of treatment / exposure:
4 hours
Observation period:
Approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.
Mortality and morbidity: twice daily
Body weight: Allocation (Day 1) and on termination (Day 4).
Number of animals:
3 females, nulliparous and non-pregnant
Details on study design:
TEST SITE
- Area of exposure: 15 cm long by 10 cm wide
- Type of wrap if used: elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure: 4 h

SCORING SYSTEM: 0-4 for erythema, eschar formation and oedema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No erythema or oedema was recorded during the observation period.
Other effects:
There was no indication of a systemic effect.
Changes in body weight seen during the course of the study were not remarkable.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item has no irritating effects on the skin of the rabbit following a 4 hour dermal exposure period.