Registration Dossier
Registration Dossier
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EC number: 607-367-1 | CAS number: 24388-70-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2000-2-3 to 2000-6-8
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- OPA-ACETAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Other effects:
- - Lesions and clinical observations:
No other than ocular lesions were noted. All lesions were reversible within 48 hours p.a.
- Ophthalmoscopic findings: Cornea and Irises: Not affected
Conjunctivae, redness: In all animals, some injected blood vessels were observed from 1 h onwards until a maximum of 24 hours p.a.
Conjunctivae, chemosis: Very slight swelling was seen in all animals 1 h p.a.
Applicant's summary and conclusion
- Executive summary:
"OPA- ACETAL" is only slightly irritating to the eyes. According to the Directive 93/21/EEC, "OPA-ACETAL" is not regarded as irritating to the eyes.
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