Registration Dossier
Registration Dossier
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EC number: 239-183-9 | CAS number: 15123-80-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 - 28 May 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Secrétariat général du GIPC - DGCIS - SI -BP 80001 - 67 rue Barbès - F-94201 IVRY-SUR-SEINE
Test material
- Reference substance name:
- Dodecaaluminium trimolybdenum dodecaoxide
- EC Number:
- 239-183-9
- EC Name:
- Dodecaaluminium trimolybdenum dodecaoxide
- Cas Number:
- 15123-80-5
- Molecular formula:
- Al2Mo3O12
- IUPAC Name:
- dialuminium(3+) tris(dioxomolybdenumbis(olate))
- Details on test material:
- - Name of test material (as cited in study report): aluminium molybdate
- CAS No.: 15123-80-5
- Physical state / Appearance: white powder
- Analytical purity: >99%
- Lot/batch No.: GRA 2011-10-13-01
- Expiration date of the lot/batch: 01 November 2018
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 weeks old
- Weight at study initiation: between 2.25 kg and 2.65 kg
- Housing: in individual boxes
- Diet (e.g. ad libitum): SAFE - 112; ad libitum
- Water: tap-water (from public distribution system - microbiological and chemical analyses of the water were carried out once every six months); ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 13
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: on the opposite flank an untreated area served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours (as no tissue destruction was noted after a treatment during 3 minutes and 1 hour)
- Observation period:
- 7 days: skin reactions were evaluated 1 hour and then 24, 48 and 72 hours and 7 days after removal of the patch
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back and flank
- % coverage: 6 cm²
- Type of wrap if used: strip of surgical adhesive tape under semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with distilled water after the removal of the patch
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Very slight erythema and edema (score = 1) were noted in all animals 1 h after removal of the patch. In 2 of 3 animals, erythemas were fully reversible within 48 hours. The third animal showed no erythema on day 7. Edemas were fully reversible within 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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