Registration Dossier
Registration Dossier
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EC number: 231-492-7 | CAS number: 7585-20-8
Skin irritation / corrosion
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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Zirconium acetate
- EC Number:
- 231-492-7
- EC Name:
- Zirconium acetate
- Cas Number:
- 7585-20-8
- Molecular formula:
- C2H4O2.xZr
- IUPAC Name:
- λ²-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 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Rabbit, New Zealand White Specific Pathogen Free (SPF)
- Details on test animals or test system 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.
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