Registration Dossier
Registration Dossier
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EC number: 203-813-0 | CAS number: 110-89-4
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on eye irritation caused by chemicals in rabbits.
- Author:
- Sugai S, Murata K, Kitagaki T, Tomita I
- Year:
- 1 990
- Bibliographic source:
- J.Toxicol.Sci. 15, 245-262
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- different scoring method
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Piperidine
- EC Number:
- 203-813-0
- EC Name:
- Piperidine
- Cas Number:
- 110-89-4
- Molecular formula:
- C5H11N
- IUPAC Name:
- piperidine
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Piperidine, Test substance No. 114
- no further data
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Takeo breeder (Shizuoka, Japan)
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: metal cages
- Diet: RC4 diet (Oriental Yeas Co., Tokyo, Japan), ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according.to the Draize score (Draize JH, Woodard G and Galvery H0 (1944); Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmcol. Exp. Ther., 82, 377-390).
READINGS: The eyes were examined and the grade of ocular reaction was recorded 1, 4, 24, 48, 72, 96hr, 7, 14 and 21 days after the treatment.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: irreversible eye damage
- Remarks on result:
- other: Eye damage score about 86.1 of 110 that persists for more than 21 days after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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