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:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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:
Source: Ferenc Sandor breeder , Kartal, Hungary
- Age at study initiation: adult albino male rabbits
- Weight at study initiation: 2944-3277 g
at study termination: 3110-3366 g
- Housing: individually in metal cages.
- Diet (e.g. ad libitum): ad libitum, UNIPLUS standard diet (AGRIBRANDS EUROPE)
- Water (e.g. ad libitum): ad libitum, potable water from automatic self-service water system
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item in pure state, as a single dose
Duration of treatment / exposure:
The eyes were not rinsed after the administration of the test item.
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
no removal

SCORING SYSTEM:
by Draize (1959) and OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: chemosis, redness, discharge
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs
Remarks on result:
other: corneal alteration were not found
Irritation parameter:
iris score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: plethoric iris reacted to light
Irritant / corrosive response data:
1 hour mean irritation index: 15.67
24 hour mean irritation index: 1.33
48 hour mean irritation index: 0.00
72 hour mean irritation index: 0. 00

Applicant's summary and conclusion

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