Registration Dossier
Registration Dossier
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EC number: 235-101-0 | CAS number: 12068-53-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Jan - 01 Feb 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study (although no information on systemic effects are given in the test report, the study is considered to be reliable without restriction as the acute dermal toxicity study did not show adverse systemic effects)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on systemic effects are given in the test report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on systemic effects are given in the test report
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
Test material
- Reference substance name:
- Dialuminium zinc tetraoxide
- EC Number:
- 235-101-0
- EC Name:
- Dialuminium zinc tetraoxide
- Cas Number:
- 12068-53-0
- Molecular formula:
- ZnAl2xO(3x+1), x = 1 – 9
- IUPAC Name:
- dialuminum; zinc(2+); oxygen(2-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): D-PrisM
- Physical state: pale yellowish powder
- Analytical purity: 100%
- Composition of test material: zinc aluminate
- Lot/batch No.: PC080519/1
- Expiration date of the lot/batch: 01.06.2018
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste, Linxe, France
- Age at study initiation: 12 - 13 weeks
- Weight at study initiation: 2.48 - 2.85
- Housing: individual
- Diet: SAFE-112, ad libitum
- Water: tap-water from public distribution system
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the test item was moistened with distilled water prior to treatment to ensure good contact with the skin
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 1 female (initial test)
2 females (confirmatory test) - Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the flank
- Type of wrap if used: The patch containing the test substance was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with distilled water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 1 h after patch removal, a very slight erythema of grade 1 was noted on the treated areas of all animals which were fully reversible after 24 h.
- Other effects:
- No systemic adverse effects are described in the report. Test animals gained approx. 100 g body weight during the study period of 3 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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