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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:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
Test carried out in accordance with the procedure set out in the "Hazardous substances regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (Feb 1965), with slight modification.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 - 16 weeks
- Weight at study initiation: 3.04 kg (M), 2.38 kg (F)
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 50 - 70 %
- Photoperiod: 15 h light / 9 h dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg


Duration of treatment / exposure:
30 seconds in 3 rabbits
No removal of test substance in the remaining 3 rabbits
Observation period (in vivo):
Observations 1, 6, 24, 48 and 72 h after application up to 6 days.
Number of animals or in vitro replicates:
6 (3 M and 3 F)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, in 3/6 rabbits using warm water
- Time after start of exposure: 30 sec.

SCORING SYSTEM:
Cornea
A Opacity-degree of density (area most dense taken for reading)
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

Iris
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal 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)

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 Diffuee 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
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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Remarks:
rinsed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
rinsed eye
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 d
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
rinsed eye
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
rinsed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
rinsed eye
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Remarks:
rinsed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Remarks:
rinsed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Other effects:
In non rinsed eye, effects on cornea and iris were not present; effects on conjunctivae, in terms of redness and/or chemosis, were present up to 72 h and 24 h, respectively. All these signs were completely reversible within 6 days.

Any other information on results incl. tables

RINSED EYE 24 h 48 h 72 h 6 d
animal #1  #2 #3 #1  #2 #3 #1  #2 #3 #1  #2 #3
cornea opacity 0 0 0 0 0 0 0 0 0 0 0 0
iris 0 0 0 0 0 0 0 0 0 0 0 0
conj. redness 1 1 0 1 0 0 1 0 0 0 0 0
conj. chemosis 1 0 0 0 0 0 0 0 0 0 0 0

UNRINSED EYE 24 h 48 h 72 h 6 d
animal #1  #2 #3 #1  #2 #3 #1  #2 #3 #1  #2 #3
cornea opacity 0 0 0 0 0 0 0 0 0 0 0 0
iris 0 0 0 0 0 0 0 0 0 0 0 0
conj. redness 2 1 2 2 1 1 1 1 1 0 0 0
conj. chemosis 1 1 1 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
No irritant to the rabbit eye.
Executive summary:

Method

Eye irritation study in 6 rabbits. 100 mg of test substance were instilled in one eye, while the other served as control. After 30 seconds, test substance was flushed out of the eye of 3/6 rabbits. Scoring for corneal opacity, iritis, conjunctivae redness and chemosis was done 1, 6, 24, 48 and 72 h and 6 d after instillation.

Results

No effects on cornea and iris were noted in both rinsed and unrinsed eye. Chemosis was noted in 1/3 rabbits with rinsed eye and in 3/3 rabbit with unrinsed eye up to 24 h; then no effects were recorded. Conjunctivae redness was noted in 5/6 rabbits, but it was completely reversible within day 6.