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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
in vivo study available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from October 6 to 9, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study well conducted, but eye not rinsed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
Basic method described in the Federal Register 1973, vol. 38, no. 187, 1500, 42.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Disperse Orange 080
IUPAC Name:
Disperse Orange 080
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leics.
- Weight at study initiation: 2.4 - 3.6 kg.
- Housing: individually in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Air changes: 20 per hour.
- Photoperiod: 12 hours light, 12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye used as control
Amount / concentration applied:
100 mg instilled into the conjunctival sac of the right eye of each rabbit. The upper and lower eyelids were held together for one second immediately after application.
Duration of treatment / exposure:
Eye not rinsed.
Observation period (in vivo):
Up to 72 hours.
Number of animals or in vitro replicates:
6 animals.
Details on study design:
SCORING SYSTEM: Draize scale for ocular lesions (1959)

Cornea
Degree of opacity (most dense area used)
0 no opacity
1 scattered or diffuse areas, details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 opalescent areas, no details of iris visible, size of pupil barely discernible
4 opaque cornea, iris invisible

Area of cornea involved:
1 one quarter or less but not zero
2 greater than one quarter, but less than half
3 greater than half, but less than three quarters
4 greater than three quarters, up to whole area


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 detsruction (any or all of these)


Conjuctivae
Redness (refers to palpebral and bulbar conjuctivae, excluding cornea and iris)
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red

Chemosis:
0 no swelling
1 any swelling above normal (includes nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids more than half closed

Discharge:
0 no discharge
1 any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 discharge with moistening of the lids and hairs just adjacent to lids
3 discharge with moistening of the lids and hairs, and considerable area around the eye

TOOL USED TO ASSESS SCORE: eye examination with standard ophtalmoscope; corneal opacity evaluated under ultra-violet illumination preceded by eye instillation of fluorescein B.P..

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

No evidence of ocular irritation in any of the test animals throughout the observation period.

hours after treatment group mean daily totals
24 0.0
48 0.0
72 0.0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
According to the CLP Regulation (EC 1272/2008), the substance is non irritant to the eye of rabbit.
Executive summary:

Method

Study in 6 rabbits by instillation of test material into the right eye of each animal. The left eye served as control. No rinse was done. Assessment of damage/irritation was made 24, 48, 72 hours after treatment and scored according to Draize scale (1959). Assessment was carried out on conjuctivae, iris and cornea.

Result

A score was associated to each animal, at 24, 48 and 72 hours after exposure. No evidence of ocular irritation was seen in any of the test animals throughout the observation period.