Registration Dossier
Registration Dossier
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EC number: 285-207-6 | CAS number: 85049-37-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 09 - 12 May 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (test substance purity not specified).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- analytical purity of test material not specified.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl palmitate
- EC Number:
- 249-862-1
- EC Name:
- 2-ethylhexyl palmitate
- Cas Number:
- 29806-73-3
- Molecular formula:
- C24H48O2
- IUPAC Name:
- 2-ethylhexyl palmitate
- Details on test material:
- - Name of test material (as cited in study report): 2-ethylhexyl palmitate
- Physical state: colorless liquid
- Analytical purity: no data
- Lot/batch No.: 950
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.34 - 2.59 kg
- Housing: Individually in suspended metal cages
- Diet: Rabbit diet, Preston Farmers Limited, New Leake, U.K., ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 65 - 66
- Air changes (per hr): 15
- 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 sites served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h (all irritation reactions were reversible within 72 hours)
Reading time points: 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Gauze patch secured with surgical adhesive tape and wrapped with an elastic corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 h
SCORING SYSTEM: According to Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24 h, 48 h and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24 h, 48 h and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24 h, 48 h and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- All animals showed slight erythema which was fully reversible within 48 to 72 hours.
Any other information on results incl. tables
Table 1. Results of skin irritation study.
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
24 h |
1 |
0 |
1 |
0 |
1 |
0 |
48 h |
1 |
0 |
0 |
0 |
1 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.67 |
0.00 |
0.33 |
0.00 |
0.67 |
0.00 |
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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