Registration Dossier
Registration Dossier
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EC number: 221-394-2 | CAS number: 3085-30-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the occular-irritation potential of 56 compounds
- Author:
- Guillot JP, Gonnet JF, Clement C, Caillard L, Truhaut R
- Year:
- 1 982
- Bibliographic source:
- . Food Chem Toxicol 20: 573-582 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Aluminium nitrate
- EC Number:
- 236-751-8
- EC Name:
- Aluminium nitrate
- Cas Number:
- 13473-90-0
- Molecular formula:
- Al.3HNO3
- IUPAC Name:
- aluminum trinitrate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rouché SA, Couhé, France
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet/ water: no data
ENVIRONMENTAL CONDITIONS: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- at 1, 24, 48, 72, 96 h and 7 days after instillation
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): additional test with washing after 4 and 30 seconds
SCORING SYSTEM: occular irritation index (Kay & Calandra)
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- >= 58.7 - <= 60.5
- Remarks on result:
- positive indication of irritation
- Remarks:
- extreme irritant
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 16.8
- Remarks on result:
- positive indication of irritation
- Remarks:
- severely irritant (rinse after 30 sec)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 1.8
- Remarks on result:
- positive indication of irritation
- Remarks:
- irritatnt (rinse after 4 sec)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Irritation is assessed in form of an overall irritation score.
- Irritant / corrosive response data:
- The pH of a saturated solution of the substance was 0.8
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance is a severe eye irritant
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