Registration Dossier
Registration Dossier
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EC number: 203-820-9 | CAS number: 110-97-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Prediction of Ocular Irritancy of 26 Chemicals and 26 Cosmeticals Products with Isolated Rabbit Eye (IRE) Test
- Author:
- Guo Xiang, et. al.
- Year:
- 2 010
- Bibliographic source:
- Biomed Environ Sci, 25 (3): 259-366
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Isolated Rabbit Eye (IRE) Test
- Principles of method if other than guideline:
- ECVAM: INVITTOX Protocol No. 85: Rabbit enucleated eye test
- GLP compliance:
- not specified
- Remarks:
- not specifically stated in the publication
Test material
- Reference substance name:
- 1,1'-iminodipropan-2-ol
- EC Number:
- 203-820-9
- EC Name:
- 1,1'-iminodipropan-2-ol
- Cas Number:
- 110-97-4
- Molecular formula:
- C6H15NO2
- IUPAC Name:
- 1,1'-iminodipropan-2-ol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: slaughterhouse
- Weight at study initiation: 2.5 kg +/- 0.3 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 10 s
- Number of animals or in vitro replicates:
- 4 eyes and 1 eye as negative control
- Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
Eyes from healthy New Zealand White rabbits (slaughterhouse)
The eyes were enucleated immediately and carefully, and the corneal opacity and fluorescein penetration were examined that they were not damaged. The eyes were placed in Isoloted Eye Superfusion System.
NUMBER OF REPLICATES
4 eyes and 1 eye as negative control
NEGATIVE CONTROL USED
POSITIVE CONTROL USED
APPLICATION DOSE AND EXPOSURE TIME
0.1 ml (Liquid test substance) for 10 s
OBSERVATION PERIOD
0.5, 1, 2, 3, or 4 hours
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: washed with 20 ml war isotonic saline
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: YZ5E slit biomicroscope
- Damage to epithelium based on fluorescein retention: slit-lamp biomicroscope
- Swelling: measured with optical pachymeter on a slit-lamp microscope; slit-width setting: UP-1000 ultrasonic pachymether
- Macroscopic morphological damage to the surface:
- Others (e.g, histopathology): corneas: loss of the epithelial cells, pitting, mottling or sloughing of the cornea
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 1
- Vehicle controls validity:
- valid
- Irritation parameter:
- other: corneal swelling (%)
- Value:
- 4
- Vehicle controls validity:
- valid
- Irritation parameter:
- other: Fluorescein Penetration
- Value:
- 0.75
- Vehicle controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Diisopropanolamine was classified as slight irritating in the Isolated Rabbit Eye Test.
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