Registration Dossier
Registration Dossier
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EC number: 263-372-5 | CAS number: 62010-10-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 25-05-1994 to 11-06-1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study performed according to OECD Guideline 404 without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zirconium oxide sulphate
- EC Number:
- 263-372-5
- EC Name:
- Zirconium oxide sulphate
- Cas Number:
- 62010-10-0
- Molecular formula:
- O16S2Zr5
- IUPAC Name:
- pentazirconium(4+) octaoxidandiide disulfate
- Details on test material:
- - Name of test material (as cited in study report): zirconium basic sulphate
- Substance type: white powder
- Physical state: solid
- Lot/batch No.: 4151805
- Analytical purity: 35.93% ZrO2 (loss on ignition) and 0.37% SiO2/ZrO2
- Purity test date: 2 May 1994
- Storage condition of test material: room temperature
- Other: date received: 09-05-1994 and provided by Thann et Mulhouse
- Other: The pH of the product at a concentration of 10% in water is 2.2.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2,6 ± 0,1 kg
- Housing: Individual housing in polystyrene cages with food and water delivery system
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum of 5 days before the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, i.e. 500 mg moistened with water - Duration of treatment / exposure:
- First rabbit: 3 minutes (left side), 1 hour and 4 hours (right side)
Based on the results of first rabbit (product not very irritating) 2 other animals were tested: 4 hours exposure. - Observation period:
- 1, 24, 48 and 72 hours after removal of the test substance
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: left and right flanks
- % coverage: no data
- Type of wrap if used: The product was applied to a dry hydrophilic gauze and moistened with water. The gauze was applied to the animals left (animal 1) and right side (animals 1, 2 and 3). The gauze was kept in contact with the skin by a semi-occlusive hypoallergical plaster and a fixation aid.
REMOVAL OF TEST SUBSTANCE
- The substance was removed with a dry gauze.
SCORING SYSTEM: Draize scoring system of erythema and edema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Only slight erythema was observed in 1 animal and was fully reversible within 48 hours.
- Other effects:
- No other effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, zirconium basic sulfate was oberved to be not irritating to rabbit skin.
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