Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo Study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2, 2002 - August 9, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Before application, the test material was ground in a mortar using a pestle.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: approx. 30 - 32 weeks
- Weight at study initiation: 4.37 kg (range from 4.06 to 4.67 kg)
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 20 °C
- Humidity (%): 41 to 77 %.
- Air changes (per hr): --

IN-LIFE DATES: From: day 1 To: day 8

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1g per animal
Observation period (in vivo):
24, 48, and 72 hours, then daily up to day 8 of the experimental part
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according OECD-Guideline

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
other: discharge
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
other: discharge
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed at the cornea or iris. The conjunctivae showed redness (score 1) in one animal at the first reading (1 hour after treatment). At later times no signs of irritation were observed. The untreated eyes were unchanged.
Other effects:
none

Any other information on results incl. tables

Study design

The test item was tested for its toxicological properties. For the test of primary eye irritation, 0.1 g of the test material was applied into the conjunctival sac of rabbits.

The study started with 1 animal and 2 animals were treated later.

The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for a further 7 days.


Results

No signs of irritation were observed at the cornea or iris. The conjunctivae showed redness (score 1) in one animal at the first reading. At later times no signs of irritation were observed. The untreated eyes were unchanged.


Conclusion

According to the EEC-Directive 91/325 the test material should not be regarded as an irritant for the eyes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.
Executive summary:

The study was performed according to OECD 405 under GLP conditions. According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.