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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
Study period:
From 19 August 1991 to 26 August 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Physical state: Clear yellow liquid
- Stability under test conditions: stable
- Storage condition of test material: between 20-30ºC in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 17 weeks
- Weight at study initiation: 2825-2910 grams
- Diet (e.g. ad libitum): 100 g per day
- Water (e.g. ad libitum): free access
- Acclimation period: five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated and served as the reference control
Amount / concentration applied:
0.1 mL per animal
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48 and 72 hours and 7 days after test substance administration
Number of animals or in vitro replicates:
three female albino rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
no irritation at 72 h after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation at 72 h after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation at 72 h after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation at 72 h after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation

Any other information on results incl. tables

DRAIZE SCORE CALCULATION

Hours/days after application
Animal No. Tissue 1 hour 24 hours 48 hours 72 hours 7 days
732 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae 6 4 4 2 0
Subtotal 6 4 4 2 0
733 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae 6 8 6 2 0
Subtotal 6 8 6 2 0
734 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae 6 8 2 2 0
Subtotal 6 8 2 2 0
TOTAL 18 20 12 6 0
MEAN TOTAL 6 6,7 4 2 0

Calculations for EEC classification

Animal No. Observation time after application Corneal opacity Iris lesion Conjunctivae redness Conjumctivae chemosis
732 24 hours 0 0 2 0
48 hours 0 0 1 0
72 hours 0 0 1 0
Mean value 0 0 1,3 0
733 24 hours 0 0 2 1
48 hours 0 0 2 1
72 hours 0 0 1 0
Mean value 0 0 1,7 0,7
734 24 hours 0 0 2 1
48 hours 0 0 1 0
72 hours 0 0 1 0
Mean value 0 0 1,3 0,3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was considered not irritant to the rabbit eye and it need not be labeled as an eye irritant according to GHS and CLP
Executive summary:

This study was entitled "Acute eye irritation/corrosion study with the substance in the rabbit". This study was carried out in accordance with OECD Guideline No.405, "Acute eye irritation/corrosion.

Under the conditions of this study, the substance resulted in adverse effects on the conjuctivae in all three animals, which had resolved within 7 days. Ocular corrosion was not observed in any of the animals. The substance was considered not irritant to the rabbit eye according to GHS and to CLP