Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 July - 04 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- (no anaesthetics were used, no initial test using one animal was performed)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 Apr 2002
- Deviations:
- yes
- Remarks:
- no anaesthetics were used, no initial test using one animal was performed
- GLP compliance:
- yes
Test material
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a cold dark place (prefabricated refrigerator, 8.6 to 11.4°C), protected from light, in a well-closed container.
- Stability of test article: stable for one year, at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Kbl:NZW [SPF]
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd., Ina, Japan
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.15 - 2.47 kg
- Housing: individual in cages, feeders were changed every week
- Diet: commercial diet RC4 (lot No. 140109, Oriental Yeast), ad libitum
- Water: tap water, ad libitum (analysis was performed)
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 - 22.4
- Humidity (%): 52 - 64
- Air changes (per hr): ≥ 8
- Photoperiod (hrs dark / hrs light): 12/ 12
IN-LIFE DATES: From: 01 July To: 04 July 2014
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein sodium solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 1 h after test substance application all animals showed conjunctival redness scored with grade 1 which was fully reversible at the 72 h reading time point in all animals. Furthermore, two animals showed chemosis scored with grade 1, which was still visible in 1/3 animals at the 24 h reading time point. Afterwards, no chemosis was observed in any animal.
The examination for corneal injury using sodium fluorescein solution revealed no lesions in any of the animals at any timepoints. - Other effects:
- Clinicle signs
The observation of the general condition didn't disclose any abnormalities in any of the animals throughout the observation period.
Body weights
All of the animals gained body weight during the study.
Any other information on results incl. tables
Table 1: Individual scores of eye irritation
Rabbit # |
Time [h] |
conjunctivae |
iris |
cornea |
|
redness |
chemosis (swelling) |
||||
1 |
1 |
1 |
1 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.7 |
0.3 |
0.0 |
0.0 |
|
2 |
1 |
1 |
0 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.7 |
0.0 |
0.0 |
0.0 |
|
3 |
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.7 |
0.0 |
0.0 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- CLP: not classified
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