Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Dated study; not reported/performed according to basic scientific principles; dated scoring system.

Data source

Reference
Reference Type:
publication
Title:
Chemical burns of the rabbit cornea.
Author:
Carpenter CP and Smyth HF Jr.
Year:
1946
Bibliographic source:
Amer. J. Ophthalmol. 29:1363-1372 .

Materials and methods

Principles of method if other than guideline:
Method preceding the OECD guidelines: Rabbits were used in which a pretest was performed to confirm absence of grossly visible abnormalities.
0.005 ml (0.02, 0.1 or 0.5 ml) of undiluted material was applied to the center of cornea while the lids if the cornea are retracted for about one minute.
Scores were noted 18-24 hours later.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No details

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.005 and 0.02 ml
Duration of treatment / exposure:
once
Observation period (in vivo):
18-24 hours
Number of animals or in vitro replicates:
not specified: 5 eyes were tested per test substance
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no



SCORING SYSTEM:
After 24hours:

Symptoms visible before fluorescein staining Points Maximum
Cornea dull 2
Cornea opaque, less than half of area 4
Cornea opaque, more than half of area 6 6
Keratoconus 6
Iritis, slight corneal congestion 1
Iritis, marked internal congestion 2 2



Symptoms visible after fluorescein staining Points Maximum
(If necrosis is diffuse assign points
corresponding to half observed area)
Necrosis on less than 5% of cornea 1
Necrosis on 5-12% 2
Necrosis on 13-37% 3
Necrosis on 38-62% 4
Necrosis on 63-87% 5
Necrosis on 88-100% 6 6


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
other: injury grade
Basis:
mean
Time point:
other: 24 hours
Score:
5
Max. score:
10
Reversibility:
not specified
Remarks on result:
other: Injury grade 5 yields a score of over 5.0: meaning that 0.005 ml gives an injury of up to 5

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment