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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:
other: OECD guideline study with acceptable restrictions (no test substance purity given). Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(adopted 1981)
Deviations:
no
Remarks:
(no deviations compared to QECD TG 405 , 1981 & 2002, except testing protocol was according to guideline version from 1981)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lupragen N 107
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: 3.03, 2.54 kg (males); 2.26 kg (female)
- Housing: 1 animal per cage
- Diet: KLIBA 341, 4 mm; Klingentalmuehle AG, CH, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
once, eyes were not washed after application
Observation period (in vivo):
15 days
The study was discontinued after 15 days due to severe eye irritation.
Number of animals or in vitro replicates:
3 (2 males, 1 female)
Details on study design:
APPLICATION
Single application to the conjunctival sac of the right eyelid

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was not washed out

READINGS
1 h, 24 h, 48 h, 72 h, 15 d after application

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.7
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Cornea score increased until study termination (3 out of 4).
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of animal 2 and 3
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Identical scores in both animals. Cornea score increased until study termination (4 out of 4); staphyloma observed in one animal.
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Identical scores in all animals. At study termination: iris score: 1
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Identical scores in all animals. At study termination: conjunctivae score: 2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of animal 1 and 2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Identical scores in both animals. At study termination: chemosis score: 2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: At study termination: chemosis score: 1
Other effects:
Additional findings observed at study termination (after 15 days):
- animal 1: loss of corneal tissue, small retractions in the eyelids, marginal vascularization of the cornea, pannus, suppuration, loss of hair at margins of eyelids
- animal 2: loss of corneal tissue, small retractions in the eyelids, marginal vascularization of the cornea, pannus, suppuration, staphyloma
- animal 3: loss of corneal tissue, small retractions in the eyelids, pupil contracted, marginal vascularization of the cornea

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria