Registration Dossier
Registration Dossier
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EC number: 801-260-5 | CAS number: 96383-55-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Feb - 05 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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): 18.1-21.0 (actual temperature)
- Humidity (%): 39-61 (actual humidity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2 cmx3 cm
- Type of wrap if used: metalline patch on micropore tape, wrapped around the abdomen and secured with coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean after 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean after 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean after 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight oedema (grade 1) were observed in all 3 animals 1 hour after exposure and were fully reversible within 24 h.
- Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
Any other information on results incl. tables
Table 1: Individual results of the skin irritation study.
Rabbit No. |
1 |
2 |
3 |
|||
Observation time |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
2 |
1 |
2 |
1 |
2 |
1 |
24 h |
2 |
0 |
1 |
0 |
1 |
0 |
48 h |
1 |
0 |
0 |
0 |
1 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
1.0 |
0.0 |
0.3 |
0.0 |
0.7 |
0.0 |
24 + 48 + 72 h |
||||||
Table 2: Age and body weight of the animals.
Rabbit No. |
1 |
2 |
3 |
Age at start (weeks) |
10-12 |
7-9 |
7-9 |
Body weight (gram) |
|
|
|
prior to application |
2484 |
1545 |
1771 |
at termination |
2605 |
1650 |
1835 |
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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