Registration Dossier
Registration Dossier
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EC number: 204-279-1 | CAS number: 118-82-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 16 Code of Federal Regulation (CFR) 1500.42 (Formerly 21 CFR 191.12)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol
- EC Number:
- 204-279-1
- EC Name:
- 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol
- Cas Number:
- 118-82-1
- Molecular formula:
- C29H44O2
- IUPAC Name:
- 2,6-di-tert-butyl-4-[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]phenol
- Details on test material:
- - Name of test material (as cited in study report): Antioxidant 702 ND
- Substance type: Antioxidant
- Physical state: Fine yellow powder
- Analytical purity: No data
- Purity test date: No data
- Lot/batch No.: 1325-76 (date: 9-14-76)
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 1.9 to 2.3 kg
- Housing: Rabbits were individually housed and equilibrated in the testing laboratory Bio/dynamics Inc.
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
Note: Only animals which were determined to be free of ocular defects prior to compound administration were used in this study.
ENVIRONMENTAL CONDITIONS : No data
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
The test material was instilled into one eye of each of the six rabbits using a 0.1 mL eye-cup . - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- The eyes were examined and scored for ocular reactions on Days 1, 2, 3, 4 and 7 following compound administration.
- Number of animals or in vitro replicates:
- Six rabbits - Test material was instilled into one eye of each of the 6 rabbits.
- Details on study design:
- SCORING SYSTEM: Similar to the score system presented in the OECD guideline 405 Acute eye irritation/corrosion
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6
- Time point:
- 24/48/72 h
- Score:
- 0.055
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 2, 3 & 4 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 2, 3 & 4 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 2, 3 & 4 days
- Score:
- 0.055
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 2, 3 & 4 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- After 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the experiment, the substance 4,4 '-Methylenebis (2,6-di-tert-butylpehnol) is not considered as irritating to eyes.
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