Registration Dossier
Registration Dossier
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EC number: 258-132-1 | CAS number: 52722-86-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1, 1992 - September 29, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Short-term Toxicology CIBA-GEIGY Limited
Test material
- Reference substance name:
- 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol
- EC Number:
- 258-132-1
- EC Name:
- 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol
- Cas Number:
- 52722-86-8
- Molecular formula:
- C11H23NO2
- IUPAC Name:
- 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol
- Details on test material:
- - Physical state: solid; white
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2500 to 2690 g
- Housing: individually in metal cages
- Diet: ad libitum, standard rabbit pellet - Nafag No. 814
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- other: substance was applied as such
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (60 mg)
- Concentration (if solution): 600mg/ml - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 1, 24, 48, 72 hours, 7, 10, 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to OECD 405
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- In all animals the mucosa of the conjuntival sac appeared strongly damaged at the readings 24, 48, and 72 hours (two animals) or only at the readings 48 and 72 hours (one animal) after instillation of the test article. In one animal a slight vascularisation of the lower marginal part of the cornea was observed from day 7 until day 10.
Any other information on results incl. tables
Individual eye scores
| conjunctiva | ||||||
| reading | animal | cornea | iris | redness | chemosis | sympomts |
| 1h | 1 | 1 | 1 | 1 | 1 | |
| 2 | 1 | 1 | 2 | 2 | ||
| 3 | 1 | 1 | 2 | 2 | ||
| 24h | 1 | 1 | 1 | 2 | 1 | |
| 2 | 0 | 1 | 3 | 1 | ||
| 3 | 2 | 1 | 3 | 1 | ||
| 48h | 1 | 1 | 1 | 3 | 1 | |
| 2 | 0 | 1 | 3 | 1 | ||
| 3 | 2 | 1 | 3 | 1 | ||
| 72h | 1 | 0 | 0 | 3 | 1 | |
| 2 | 0 | 0 | 3 | 1 | ||
| 3 | 2 | 1 | 3 | 1 | ||
| 7 d | 1 | 0 | 0 | 1 | 0 | |
| 2 | 0 | 0 | 2 | 0 | ||
| 3 | 0 | 0 | 2 | 0 | vascularisation | |
| 10d | 1 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 1 | 0 | ||
| 3 | 0 | 0 | 1 | 0 | vascularisation | |
| 14d | 1 | - | - | - | - | |
| 2 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | ||
| mean 24-72h | 1 | 0.7 | 0.7 | 2.7 | 1.0 | |
| 2 | 0.0 | 0.7 | 3.0 | 1.0 | ||
| 3 | 2.0 | 1.0 | 3.0 | 1.0 | ||
| mean 24-72h | 0.9 | 0.8 | 2.9 | 1.0 | ||
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance caused irritation reactions in the rabbot eye triggering classification.
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