Registration Dossier
Registration Dossier
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EC number: 270-472-2 | CAS number: 68441-68-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 - 30 June 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decanoic acid, mixed esters with octanoic acid and pentaerythritol
- EC Number:
- 270-472-2
- EC Name:
- Decanoic acid, mixed esters with octanoic acid and pentaerythritol
- Cas Number:
- 68441-68-9
- Molecular formula:
- C23H48O8
- IUPAC Name:
- 3-(decanoyloxy)-2,2-bis[(octanoyloxy)methyl]propyl decanoate; 3-(decanoyloxy)-2-[(decanoyloxy)methyl]-2-[(octanoyloxy)methyl]propyl decanoate; 3-(octanoyloxy)-2,2-bis[(octanoyloxy)methyl]propyl decanoate; 3-(octanoyloxy)-2,2-bis[(octanoyloxy)methyl]propyl octanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ELEVAGE DES FEUILLETAS
- Weight at study initiation: 1.8 - 2.2 kg
- Housing: individually in stainless steel cages
- Diet: UAR 112, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days under the same conditions with respect to housing and feeding as those used during the test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 27
- Humidity (%): 30 - 80
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 14 cm x 14 cm on back and side of animals
- Type of wrap if used: the applied gauze patch was fixed with an hypoallergenic microporous adhesive strip, which was then covered with a stretchable band wrapped around the animal without any restraint for respiratory and abdominal movements.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- At the 1h reading a slight erythema formation was observed in all 3 animals (score 2 in 1 animal and score 1 in the other two animals), which were fully reversible within 48 h after test substance application in 2/3 animals. The third animal showed no signs of erythema at the 72 h reading. No edema reaction was observed at any time in any animal over the complete duration of the test.
- Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Erythema scores
|
Animal #1 |
Animal #2 |
Animal #3 |
1 h |
2 |
1 |
1 |
24 h |
1 |
0 |
1 |
48 h |
0 |
0 |
1 |
72 h |
0 |
0 |
0 |
Edema scores
|
Animal #1 |
Animal #2 |
Animal #3 |
1 h |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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