Registration Dossier
Registration Dossier
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EC number: 242-182-6 | CAS number: 18299-85-9
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:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12 th, 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Octadecyl acrylate
- EC Number:
- 225-383-3
- EC Name:
- Octadecyl acrylate
- Cas Number:
- 4813-57-4
- Molecular formula:
- C21H40O2
- IUPAC Name:
- octadecyl acrylate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler: D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean weight (Male): 2.82 kg; (female): 2.88 kg
- Housing: single; cage made of stainlees steel with wire mesh walk floors, Floor area: 40 cm x 51 cm
- Diet: Kliba 341, 4mm: Firma Klingentalmuehle AG; CH-4304 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 h /12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume (about 32 mg of the comminuted test substance) - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- - 2 males
- 1 female - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
Scale for scoring ocular lesions:
- Chemosis (SW) and Cornea (OP) (Opacity-degree of density):
0 = None
1 = slight
2 = well-defined
3 = severe
4 = very severe
- Conjunctivae redness (RED):
0 = Normal
1 = slight
2 = well-defined
3 = severe
- Iris:
0 = Normal
1 = circum-corneal injection
2 = iritis
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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