Registration Dossier
Registration Dossier
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EC number: 260-694-8 | CAS number: 57357-85-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- according to Fed. Reg. 38, 187, § 1500.42, 1973; Draize test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- [1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine
- EC Number:
- 260-694-8
- EC Name:
- [1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine
- Cas Number:
- 57357-85-4
- Molecular formula:
- C11H21N
- IUPAC Name:
- 1-[(1S,2S,3S,5R)-2,6,6-trimethylbicyclo[3.1.1]heptan-3-yl]methanamine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- OTHER SPECIFICS:
pH 9
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.3 - 2.8 kg
- Diet: ad libitum, standardized animal laboratory diet
Test system
- Vehicle:
- other: olive oil
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 95.3 % in olive oil (w/v)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was not washed out.
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: Readings of the reaction of the palpebral conjunctiva and of the eye are made 1, 24, 48, and 72 h after instillation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: value could not be exactly determined
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Eight days after test substance instillation, purulent necrotic changes of the Bulbus oculi were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
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