Registration Dossier
Registration Dossier
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EC number: 262-634-6 | CAS number: 61167-58-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Feb - 28 Mar 1983
- 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:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted Oct 2012
- Deviations:
- yes
- Remarks:
- no topical anesthetics and systemic analgesics were used; no initial test was performed
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methylphenyl acrylate
- EC Number:
- 262-634-6
- EC Name:
- 2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methylphenyl acrylate
- Cas Number:
- 61167-58-6
- Molecular formula:
- C26H34O3
- IUPAC Name:
- 2-tert-butyl-6-[(3-tert-butyl-2-hydroxy-5-methylphenyl)methyl]-4-methylphenyl prop-2-enoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nihon Dobutsu Co., Osaka, Japan
- Weight at study initiation: 2.35 - 2.68 kg
- Diet: CG-3 type (Clea Japan Inc., Osaka, Japan), 100 g/day
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 60 ± 10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- Group 1: Single application without washing
Group 2: 30 s - Observation period (in vivo):
- 1, 24, 48, 72 and 96 h and 7 days
- Number of animals or in vitro replicates:
- 6 (Group 1) and 3 (Group 2)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of the animals in Group 2 were rinsed with lukewarm water
- Time after start of exposure: 30 s (Group 2); the treated eye remained unwashed following the instillation (Group 1)
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: washed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: washed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: washed
- Irritant / corrosive response data:
- All animals showed no conjunctival redness and swelling resulting in a mean score of 0 for both endpoints over 24, 48 and 72 h, respectively. The cornea opacity and iris score were also graded with scores of 0 over 24, 48 and 72 h, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.
- Conclusions:
- CLP: not classified
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