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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
Study period:
08 January 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Assessment of the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not applicable. Test was conducted ex vivo.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: two additional eyes remained untreated for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Not applicable

VEHICLE
No vehicle used
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
Assessment of corneal cloudiness was made pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment.
Number of animals or in vitro replicates:
Test was carried out ex vivo. Three enucleated eyes were treated with test material.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After ten seconds the test material was washed off the cornea using a minimum of 20 ml of saline solution (approximately 32°C).
Immediately following washing of the corneal surface, the treated eye was returned to the superfusion chamber and the saline drip repositioned to irrigate the eye.
The untreated eyes were similarly washed and used for control purposes.

- Time after start of exposure: 10 seconds


SCORING SYSTEM: numerical evaluation adopted from Advances in Modern Toxicology: Dermatoxicology, 4th Ed, (F Marzulli and H Maibach, eds) Hemisphere Publishing Corporation, Washington DC, 1991, pp 749-815

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of a slit-lamp biomicroscope. The thickness of the cornea was measured using an ultrasonic pachymeter.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
percent corneal swelling
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: A mean value for corneal swelling was calculated for the test and control eyes for the 60, 120 and 240 minutes post treatment. Corneal swelling of the test eyes was considerably greater than that observed in the control eyes over the same period.
Irritation parameter:
cornea opacity score
Value:
8
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Some loss or moderate loss of transparency was noted in all test eyes. scores >=4 -8=<
Irritation parameter:
fluorescein leakage
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Slight to moderate fluorescein uptake was noted in the test eyes 240 minutes following test material application

Any other information on results incl. tables

          

Corneal opacity:

Some loss or moderate loss of transparency was noted in all test eyes. No corneal effects were noted in the control eyes during the study period.

       

Corneal thickness and condition:     

Corneal swelling of the test eyes during the study period was considerably greater than that observed in the control eyes over the same period.

Sloughing of the corneal epithelium was noted in test eyes. The condition of the corneal epithelium of the control eyes appeared normal during the study period.

Fluorescein uptake:              

Slight to moderate fluorescein uptake was noted in the test eyes 240 minutes following test material application. No fluorescein uptake was noted in the control eyes 240 minutes following treatment.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: As specified in the test method
Conclusions:
Following assessment of the data for all endpoints, the substance is considered to have the potential to cause severe ocular irritancy in vivo.
Executive summary:

The substance is considered to have the potential to cause severe ocular irritancy in vivo based on the results of a rabbit enucleated eye test.