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Toxicological information

Eye irritation

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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:
2010
Bibliographic source:
Biomed Environ Sci, 25 (3): 259-366

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent

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.