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Registration Dossier
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EC number: 296-664-6 | CAS number: 92908-35-5
Eye irritation
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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Fixapret CP konz., PBG = 10073662, after Concentration
- Analytical purity: 93.4 %
- Lot/batch No.: 000335MCA0
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Age at study initiation: 6 -7 months
- Weight at study initiation: 3.92-4.01 kg
- Housing: single housing
- Diet (e.g. ad libitum): Kliba Labordiät (Kaninchen & Meerschweichenhaltung "GLP")
- Water (e.g. ad libitum): ad. libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated felt eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h - 48h - 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h - 48h - 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h - 48h - 72h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h - 48h - 72h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- In addition, injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period.
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosid |
Discharge |
||||
1h |
01 |
0 |
0 |
0 |
2 |
2 |
3 |
49 |
02 |
0 |
0 |
0 |
2 |
2 |
1 |
49 |
|
03 |
0 |
0 |
0 |
2 |
2 |
3 |
49 |
|
24 h |
01 |
0 |
0 |
0 |
1 |
0 |
1 |
48 |
02 |
0 |
0 |
0 |
2 |
1 |
0 |
48 |
|
03 |
0 |
0 |
0 |
1 |
1 |
1 |
48 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
|
02 |
0 |
0 |
0 |
1 |
0 |
0 |
48 |
|
03 |
0 |
0 |
0 |
1 |
0 |
0 |
48 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
|
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean 24-72 h |
01 |
0.0 |
|
0.0 |
0.3 |
0.0 |
|
|
02 |
0.0 |
|
0.0 |
1.0 |
0.3 |
|
|
|
03 |
0.0 |
|
0.0 |
0.7 |
0.3 |
|
|
|
Mean |
|
0.0 |
|
0.0 |
0.7 |
0.2 |
|
|
48 = scleral vessels injected, circumscribed area
49 =scleral vessels injected, circular
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