Registration Dossier
Registration Dossier
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EC number: 239-183-9 | CAS number: 15123-80-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Secrétariat général du groupe interministeriel des produits chimiques (GIPC), 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))
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): aluminium molybdate
- Physical state: white powder
- Analytical purity: >99%
- Batch No.: GRA 2011-10-13-01
- Expiration date of the batch: 01 November 2018
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labste - F40260 Linxe)
- Age at study initiation: 11 or 13 weeks old
- Weight at study initiation: between 2.04 and 3.04 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned rooms.
- Diet: SAFE - 112; ad libitium
- Water: tap-water from public distribution system; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days (for animal A2800); 72 h (for animals A2839 and A2840)
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes were rinsed with physiological saline (solid test substance has not been removed from the eyes of the test animals by physiological mechanisms at the first observation time point of 1 hour after instillation)
- Time after start of exposure: 1 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- 1 h after test item instillation, all animals showed effects on the conjunctivae (redness: score 1 -2; chemosis: score 1). Conjunctival redness was fully reversible within 24 h for animal no. A2839, within 72 h for animal no. A2840 and within 7 days for animal no. A2800, respectively. Chemosis was fully reversible within 24 h for animal no. A2839, within 48 h for animal no. A2840 and within 72 h for animal no. A2800, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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