Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

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:
and Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

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
- Source: Breeder: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 - 4 months
- Weight at study initiation: 2.8 ± 0.3 kg
- Housing: individually in polystyrene cages (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): ad libitum, 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water (filtered)
- Acclimation period: 5 days (at least)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

VEHICLE
No vehicle
Duration of treatment / exposure:
The eyes were not rinsed after administration of the test item.
Observation period (in vivo):
1h, 2h, 48h, 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed after administration of the test item.
SCORING SYSTEM: Xi symbol

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24 h
Score:
0.7 - 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: chemosis - redness
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24 h, 48h, 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24h, 48h, 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Slightly irritant ti rabbit eye.
Other effects:
Notes: Max score: 2 (one animal, conjunctivae. 24 h).

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified.