Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth H.F.; Carpenter, C.P.; Weil C.S.; Pozzani, U.C.; Striegel, J.A.
Year:
1962
Bibliographic source:
American Industrial Toxicity Data: List VI 23: 95 - 107
Reference Type:
secondary source
Title:
HSDB
Year:
2003
Bibliographic source:
http://www.safe.nite.go.jp/english/ghs/11-mhlw-0074e.html

Materials and methods

GLP compliance:
no

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:
Normal albino rabbit eyes are selected on the basis of absence of grossly visible staining by a 5-percent aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after application. (described in Carpenter and Smyth, CHEMICAL BURNS OF THE RABBIT CORNEA, 1946)

Test system

Controls:
not specified
Amount / concentration applied:
various volumes and concentrations
Duration of treatment / exposure:
18-24 h (described in Carpenter and Smyth, CHEMICAL BURNS OF THE RABBIT CORNEA, 1946)
Details on study design:
0.005 ml. of the undiluted material is applied to the center of the cornea while the lids are retracted. About one minute later, the lids are released. Eighteen to 24 hours later, the eye is examined in strong diffuse daylight, then stained with fluorescein, and the injury scored. Guided by the result and the table of injury grades, additional applications are made until the chemical can be assigned to one of the grades we recognize. The system depends partly on volume and partly on concentration. The combination is necessary to separate the damage produced by chemicals of obviously diverse abilities to injure that cannot be distinguished on the basis of the reaction to 0.005 ml. undiluted. If large volumes are applied, the lids are held closed for one minute before the animal is released. (described in Carpenter and Smyth, CHEMICAL BURNS OF THE RABBIT CORNEA, 1946)

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
5
Max. score:
10
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Remarks:
Grade 5 indicates a so-called severe burn from 0.005 ml
Irritant / corrosive response data:
The degree of injury observed 24 hours after application to rabbits was rated as 5 (the most severe injuries are rated 10) on a scale of 1 to 10 (HSDB (2003)), but it was classified in Category 2 without sub-categorization due to unknown details on a recovery period and so on.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria