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Registration Dossier
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EC number: 605-658-8 | CAS number: 173011-06-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptabele restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2-hydroxyethoxy)propyl prop-2-enoate; 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]butoxy]ethoxy]propyl 3-(dibutylamino)propanoate
- EC Number:
- 605-658-8
- Cas Number:
- 173011-06-8
- Molecular formula:
- Not specified UVCB - Reaction product of ethoxylated/propoxylated (0-6 EO; 0-6 PO) propylidenetrimethanol with acrylic acid and dibutylamine (acrylic acid : dibutylamine = 3:1)
- IUPAC Name:
- 2-(2-hydroxyethoxy)propyl prop-2-enoate; 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]butoxy]ethoxy]propyl 3-(dibutylamino)propanoate
- Details on test material:
- - Name of test material (as cited in study report): Laromer LR 8864
- Physical state: liquid, colorless
- Analytical purity: 100 %
- Lot/batch No.: R /395
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, FRG
- Weight at study initiation: male: 2.78 kg; female: 2.66 kg
- Housing: 1 animal per cage
- Diet (e.g. ad libitum): Kliba 341, 130 g per animalper day
- Water (e.g. ad libitum): 250 ml tap water per animal per day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- male. 2
female: 1 - Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze + porous bandage
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Remarks:
- 24 - 48- 72h
- Basis:
- mean
- Time point:
- other: 24 - 48- 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- 24 - 48- 72h
- Basis:
- mean
- Time point:
- other: 24 - 48- 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
Any other information on results incl. tables
Readings:
Time |
Animal No. |
Erythema |
Edema |
4h |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
1 |
0 |
|
24h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
1 |
0 |
|
48h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
72h |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
Mean |
|
0.3 |
0 |
Applicant's summary and conclusion
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