Registration Dossier
Registration Dossier
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EC number: 203-751-4 | CAS number: 110-27-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-06-17 to 1986-06-24
- 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isopropyl myristate
- EC Number:
- 203-751-4
- EC Name:
- Isopropyl myristate
- Cas Number:
- 110-27-0
- Molecular formula:
- C17H34O2
- IUPAC Name:
- isopropyl myristate
- Details on test material:
- - Name of test material (as cited in study report): isopropyl myristate
- Physical state: colourless liquid
- Analytical purity: approx. 100%
- 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: Male
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: approx. 3000 g
- Diet: 100 g/day (Standart laboratory animal diet LK-01)
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 23
- Humidity (%): 60-85
- 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:
- 4h
- Observation period:
- 1h, 24h, 48h, 72h and 7d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: air- and vapor permeable gauze-patch fixed with a flexible bandage
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) (Draize)
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: 481
- Time point:
- other: average 24, 48 and 72h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal: 487
- 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:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal: 481
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: 487
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- The test substance caused very slight erythema dissappearing completely within 7 days. Only one animal had slight edema up to 48 h after application.
Any other information on results incl. tables
Erythema score
Animal Number |
24 h |
48 h |
72 h |
7 days |
Mean (24-72 h) |
480 |
1 |
1 |
1 |
0 |
1.0 |
481 |
1 |
1 |
1 |
0 |
1.0 |
487 |
1 |
1 |
1 |
0 |
1.0 |
Edema Score
Animal Number |
24 h |
48 h |
72 h |
7 days |
Mean (24-72 h) |
480 |
1 |
1 |
0 |
0 |
0.66 |
481 |
0 |
0 |
0 |
0 |
0.0 |
487 |
0 |
0 |
0 |
0 |
0.0 |
According to DSD and CLP the test substance has not to classified.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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