Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Reliability 4 has been assigned due to the lack of information on the composition of test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Based on: Federal Register 38 no. 187, 1550.42 (eye), S. 27019, 27.09.73
GLP compliance:
no

Test material

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

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cages without litter
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: > 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 h light / 12 h dark

Test system

Controls:
yes
Amount / concentration applied:
0.1 ml of solution or 100 mg of powder.
Duration of treatment / exposure:
No rinsing of the eye.
Observation period (in vivo):
1h, 24 h, 48 h, 72 h up to 7 days after application.
Number of animals or in vitro replicates:
6.
Details on study design:
SCORING SYSTEM: Draize
Cornea opacity
0 no opacity
1 scattered or diffuse area, details of iris clearly visible
2 easily discernible translucent areas, details of iris slightly obscured
3 opalescent areas, no details of iris visible, size of pupil barely discernible
4 opaque, iris invisible

Iris
0 normal
1 folds above normal, congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, hemorrhage, gross destruction (any or all of these)

Conjunctivae redness
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red

Conjunctivae chemosis
0 no swelling
1 any swelling above normal (includes nictitating membrane)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids about half closed to completely closed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Remarks:
due to substance colour
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
5 rabbits
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2.7
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3.7
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 3.3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
not determinable
Remarks:
due to severe swelling and gluing of the eye with suppurative mucus.
Other effects:
1 h after application of the test substance in all rabbits strong swelling of the conjunctivae and strong secretion on the treated eyes. Cornea was not evaluated after 1 h, as the entire eye turns blue-black due to test substance.
Up to 48 h after application in all rabbits hardened nickel skin. After 72 h at 1 rabbit small bleeding at the lower lid margin. 72 h after application until the end of the observation period (7 d), the eyes were covered or glued with purulent mucus in all rabbits. 48 h to 7 d after application hairs at the lower lid margin approx. 4 cm firmly bound with substance and pus.
The pathological findings on the eye and the irritation of the mucous membrane were not reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
other: irreversible effects on eye - cat. 1 according to the CLP Regulation (EC 1272/2008)
Conclusions:
Irreversible effects in the eye of rabbits.
Executive summary:

Method

A study on 6 rabbits was conducted to assess the eye irritation potential of test substance, by application of test substance in one eye. The other eye served as control. No rinsing of the eye was performed and assessment was performed 1 h, 24 h, 48 h, 72 h up to 7 d after instillation. Effects of corneal opacity, conjunctivae redness and chemosis and effects on iris were scored according to Draize scale.

Results

Due to substance-induced colouring, it was not possible to assess redness of the ocular mucosa. Severe effects on iris, cornea (opacity) and conjuctivae (chemosis) were evident in all animals. Pathological findings on eye and irritation of mucous membrane were not reversible within 7 days.