Registration Dossier
Registration Dossier
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EC number: 212-554-2 | CAS number: 826-36-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- GLP was not implemented at that time.
Test material
- Reference substance name:
- 2,2,6,6-tetramethyl-4-piperidone
- EC Number:
- 212-554-2
- EC Name:
- 2,2,6,6-tetramethyl-4-piperidone
- Cas Number:
- 826-36-8
- Molecular formula:
- C9H17NO
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.0 kg
- Housing: individually in steel cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 60% +/- 5%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15.10.1985 To: 18.10.1985
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Amount: 0.1 g
- Duration of treatment / exposure:
- 72 h (experiment was stopped after 72 h due to severe lesions)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm physiological saline solution
- Time after start of exposure: 72 h
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Bleeding of the conjunctivae, necrosis of the conjunctivae sac, detachment of mucous membranes. Due to the severe effects the study was terminated after 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study the test item caused serious damage to eyes.
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