Registration Dossier
Registration Dossier
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EC number: 247-655-0 | CAS number: 26399-02-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 18 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation (analytical purity of test substance not given, occlusive exposition according to former guideline, lack of detailed reporting).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive exposition according to former guideline, analytical purity of test substance not specified, lack of detailed reporting;
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-ethylhexyl oleate
- EC Number:
- 247-655-0
- EC Name:
- 2-ethylhexyl oleate
- Cas Number:
- 26399-02-0
- Molecular formula:
- C26H50O2
- IUPAC Name:
- 2-ethylhexyl octadec-9-enoate
- Details on test material:
- - Name of test material (as cited in study report): oléate ethyl 2 hexyle
- Analytical purity: no data
- Lot/batch No.: 2903
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2285 g
- Date of reception: Februar 19th, 1991
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 1, 24, 48 and 72h
72 h - Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM: According to Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- When administered occlusive for 4h to rabbit skin, the test substance caused only slight irritations in one animal after 24h that were fully reversible within 48h.
Any other information on results incl. tables
Erythema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
3 |
2 |
1 |
0 |
0 |
Edema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
3 |
2 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
GHS: not classified
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