Registration Dossier

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2002)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: HsdIf:NZW
- Sex: female
- Source: Harlan France, 03800 Gannat, France
- Age at study initiation: young adult animals
- Weight at study initiation: 2.3-2.5 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 25 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, which remained untreated, served as control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The eye-lids were gently held together for about one second in order to prevent loss of the test compound. The eye was not rinsed for at least 24 hours following instillation.
Observation period (in vivo):
Examinations were terminated after 72 hours, since all changes had completely subsided then.
Number of animals or in vitro replicates:
3
Details on study design:
Due to animal welfare reasons only one animal was tested at first. If one hour after treatment a severe irritation was not observed, two further rabbits were treated.

PROCEDURE: On the day before the test, both eyes of each animal were examined including fluorescein examination. Only animals with healthy intact eyes were used.
0.1 mL of the pure liquid test substance was placed into the conjunctival sac of one eye ofthe first animal after having gently pulled the lower lid away from the
eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound. The other eye, which remained untreated, served as control. The eye was not rinsed for at least 24 hours following instillation.

SCORING SYSTEM: Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48h, and 72h
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: mean score: 0.3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72h
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 72h
Remarks on result:
other: mean score: 1.0
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Conclusions:



Classification: not irritating
Executive summary:

An Acute Eye Irritation/Corrosion test was conducted according to OECD 405. In this study no corneal damage, no iridial inflammation and no conjunctivae chemosis was observed (all scores zero). The substance elicited very slight conjunctival irritation (mean scores conjuncivae redness 0.43). There were no systemic intolerance reactions.