Registration Dossier
Registration Dossier
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EC number: 801-260-5 | CAS number: 96383-55-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Mar - 11 Mar 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroprop-2-enoate
- EC Number:
- 801-260-5
- Cas Number:
- 96383-55-0
- Molecular formula:
- C11H6ClF13O2
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): Alpha-Chloro C-6 Monomer
- Physical state: colourless liquid
- Lot/batch No.: C61204
- Expiration date of the lot/batch: 31 Aug 2004
- Storage condition of test material: In refrigerator in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: single housing
- Diet: Standard laboratory diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany), approx. 100 g per day. Hay was provided three times per week.
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0-21.0 (actual temperature)
- Humidity (%): 37-66 (actual humidity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 72 h
(scoring after 1, 24, 48, and 72 h) - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
After the 24-h observation a solution of 2% fluorescein in water (pH 7) was instilled to both eyes of each animal to quantitatively determine corneal epithelial damage.
OBSERVATIONS:
Mortality/viability: checked twice daily
Toxicity: at least one daily
Body weight: day of treatment and at termination
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- After 1 h all 3 animals showed mild to moderate redness (score 1/2/2). At 24 h redness was reversed in 1 animal and the score of 2 was reduced to 1 in the other 2 animals. After 48 h no redness was observed in any animal.
Any other information on results incl. tables
Table 1: Individual results of eye irritation study.
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.3 |
0.0 |
0.0 |
0.0 |
|
2
|
1 |
2 |
0 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.3 |
0.0 |
0.0 |
0.0 |
|
3
|
1 |
1 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.0 |
0.0 |
0.0 |
0.0 |
|
|
|||||
|
Time [h] |
conjunctivae
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average score |
1 |
1.67 |
0.00 |
0.00 |
0.00 |
24 |
0.67 |
0.00 |
0.00 |
0.00 |
|
48 |
0.00 |
0.00 |
0.00 |
0.00 |
|
72 |
0.00 |
0.00 |
0.00 |
0.00 |
|
24+48+72 |
0.22 |
0.00 |
0.00 |
0.00 |
|
Table 2: Age and body weight of individual animals.
Rabbit No. |
1 |
2 |
3 |
Age at start (weeks) |
11-13 |
10-12 |
10-12 |
Body weight (gram) |
|
|
|
prior to application |
2398 |
2575 |
2413 |
at termination |
2541 |
2890 |
2610 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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