Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione
- Physical state: solid
- Analytical purity: commercial grade
- Lot/batch No.: Op. 11006
- Expiration date of the lot/batch: 1995-12-31
- Stability of test article: stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: 2600 g - 2800 g
- Housing: individually in stainless steel cages.
- Diet (ad libitum): pelleted standard Kliba 341, rabbit maintenance diet.
- Water (ad libitum): tap water
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
0.1 g of undiluted test article was applied to the left eye of each animal.
Duration of treatment / exposure:
The eye was not rinsed after application.
Observation period (in vivo):
Scoring of irritation effects was performed approximately 1 h, 24 h, 48 h and 72 h after application.
Number of animals or in vitro replicates:
3 animals ( 1 male, 2 females)
Details on study design:
SCORING SYSTEM according to OECD 405 (1981):

CORNEA
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

CONJUNCTIVAE
Redness (refers to most severe reading of palpebral and bulbar conjunctivae when compared with control eye)
Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3

CHEMOSIS: lids and/or nictitating membranes
No swelling 0
Any swelling above normal (including nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, since no effects in cornea were seen
Remarks on result:
other: no effects were seen in any of the animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable, since no iridic irritation was seen
Remarks on result:
other: no effects were seen in any of the animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable, since no redness was seen
Remarks on result:
other: no effects were seen in any of the animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, since no signs of chemosis were seen
Remarks on result:
other: no effects were seen in any of the animals
Other effects:
No clinical signs of systemic toxicity were observed and no mortality occurred. Red residues were observed at 1 h in all animals. No discoloration of the cornea and conjunctivae was observed.

Applicant's summary and conclusion

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