Registration Dossier
Registration Dossier
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EC number: 205-571-1 | CAS number: 142-91-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 01st, 1986 - July 15th, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isopropyl palmitate
- EC Number:
- 205-571-1
- EC Name:
- Isopropyl palmitate
- Cas Number:
- 142-91-6
- Molecular formula:
- C19H38O2
- IUPAC Name:
- propan-2-yl hexadecanoate
- Details on test material:
- - Name of test material (as cited in study report): isopropyl palmitate
- Physical state: colourless liquid
- Analytical purity: approx. 100% ester
- Storage condition of test material: RT 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
- Sex: Female
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: Mean 3446 g
- Diet: Standart laboratory animal diet LK-01
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 65 - 85
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The test substance was applied to a gauze patch which was attached with a drop of petrolatum to aluminium foil and mounted on a permeable tape (Micropore, 3M, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, using a tissue moistened with tap-water
SCORING SYSTEM: According to the criteria for irritancy and corrosiveness on the skin, Off. J. Europ. Commun., L 180/56 (91/325/EEC)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 480
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal: 483
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- erythema score
- Basis:
- animal: 484
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal: 480
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: 483
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal: 484
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Erythema Score
Animal Number |
24 h |
48 h |
72 h |
7 days |
14 days |
Mean (24-72 h) |
480 |
1 |
1 |
1 |
0 |
0 |
1.0 |
483 |
1 |
2 |
2 |
1 |
0 |
1.7 |
484 |
1 |
1 |
1 |
0 |
0 |
0.0 |
Edema Score
Animal Number |
24 h |
48 h |
72 h |
7 days |
14 days |
Mean (24-72 h) |
480 |
0 |
0 |
0 |
0 |
0 |
0.0 |
483 |
0 |
1 |
1 |
0 |
0 |
0.7 |
484 |
0 |
0 |
0 |
0 |
0 |
0.0 |
The dermal application of the test substance to rabbits caused very slight to well-defined erythema dissappearing completely within 7 to 14 d. According to DSD and CLP the test substance has not to be classified.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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