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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in foods, drugs and cosmetics - AFDO
Version / remarks:
1959
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
OB 134
IUPAC Name:
OB 134

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hour light cycle day

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml inserted into the conjunctival sac.
Duration of treatment / exposure:
- 30 second in rinsed (3 / 6 rabbits)
- unrinsed (3 / 6 rabbits)
Observation period (in vivo):
Day 1, 2, 3, 4 and 7.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM:
A - Opacity and degree of density (most dense area scored)
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
B - 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
A × B × 5 Maximum possible score = 80

IRIS:
A - Values
0 Normal
1 Folds above normal, congestion, swelling, circumcornea injection (any or 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)
A × 5 Maximum possible score = 10

CONJUNCTIVAE:
A - Redness (refers to palpebral and bulbar conjunctivae 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
B - 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 ...
C - 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
(A + B + C) × 2 Maximum possible score = 20

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not reported

Any other information on results incl. tables

Eye rinsed 30 seconds after treatment

animal 1 (F) 2 (F) 3 (F)
day after application cornea iris conjunctivae cornea iris conjunctivae cornea iris conjunctivae
1 0 0 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0 0 0
3 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0

Eye not rinsed after treatment

animal 4 (F) 5 (F) 6 (F)
day after application cornea iris conjunctivae cornea iris conjunctivae cornea iris conjunctivae
1 15 0 8 15 0 10 20 0 10
2 10 0 6 10 0 8 15 0 8
3 5 0 6 0 0 6 5 0 6
4 0 0 0 0 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to the eye of rabbits.
Executive summary:

Method

Eye irritation in rabbits according to test procedure described in AFDO (1959). Test substance was applied to the left eye of 6 rabbits, while the right eye served as control. In 3 / 6 rabbits, treated eye was rinsed ca. 30 seconds after application, while in the remaining rabbits, the eye was not rinsed. Observations for signs of irritation on cornea, iris and conjunctivae were done 1, 2, 3, 4 and 7 days after start of exposure.

Results

No signs of irritation were noted on rinsed eye. In case of unrinsed eye, effects on cornea and conjunctivae were noted, which, however, disappeared within the 4th day.