Registration Dossier
Registration Dossier
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EC number: 616-749-7 | CAS number: 79869-59-3
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
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:
- The substance is applied in the eye of the rabbit undiluted. Observations are recorded 10 min, 1 hour, 3 hours, 24 hours, 48 hours, 72 hours, 4days, 7 days and 8 days after application.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,10-bis(2-methylpropyl) perylene-3,10-dicarboxylate; 3,9-bis(2-methylpropyl) perylene-3,9-dicarboxylate
- EC Number:
- 616-749-7
- Cas Number:
- 79869-59-3
- Molecular formula:
- C30H28O4
- IUPAC Name:
- 3,10-bis(2-methylpropyl) perylene-3,10-dicarboxylate; 3,9-bis(2-methylpropyl) perylene-3,9-dicarboxylate
- Details on test material:
- - Analytical purity: 100%
- Name of test material (as cited in study report): Fluorolgruengold Misch. Nr. 27-3887
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye treated with talcum
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
CONTROL
- left eye was treated with talcum powder - Duration of treatment / exposure:
- eyes were not rinsed after application
- Observation period (in vivo):
- 8 days
intervals: after; 10 mins, 1 h, 3 h, 24 h 48 h, 72 h, 4 days 7 days and on day 8 - Number of animals or in vitro replicates:
- 2 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
- BASF internal method with was translated to Draize scores
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Minimal erythema reactions were reported (maximum score = 1), reversible within 72 hours. One hour after instillation discharge was reported in all animals and in 2/6 rabbits edema formation was observed. These effects were reversible within the first 24 hours.
Any other information on results incl. tables
| Cornea | Conjunctiva | |||||
| Readings | Animal | Opacity | Iris | Redness | Chemosis | Further findings |
| 10 min | 1 | 0 | 0 | 1 | 0 | orange substance residues |
| 2 | 0 | 0 | 1 | 0 | ||
| 1h | 1 | 0 | 0 | 1 | 0 | substance residues |
| 2 | 0 | 0 | 1 | 0 | substance residues | |
| 3h | 1 | 0 | 0 | 1 | 1 | |
| 2 | 0 | 0 | 1 | 0 | ||
| 24h | 1 | 0 | 0 | 1 | 0 | |
| 2 | 0 | 0 | 1 | 0 | ||
| 48h | 1 | 0 | 0 | 1 | 0 | |
| 2 | 0 | 0 | 1 | 0 | ||
| 72h | 1 | 0 | 0 | 1 | 0 | |
| 2 | 0 | 0 | 1 | 0 | ||
| 4 days | 1 | 0 | 0 | 1 | 0 | |
| 2 | 0 | 0 | 0 | 0 | ||
| 7 days | 1 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | ||
| 8 days | 1 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | ||
| Mean (24h-72h) | 1 | 0 | 0 | 1 | 0 | |
| 2 | 0 | 0 | 1 | 0 | ||
| Mean (24h-72h) | all animals | 0 | 0 | 1 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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