Registration Dossier
Registration Dossier
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EC number: 233-864-4 | CAS number: 10401-55-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Very few details on materials and methods, substance purity not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Jul 2015
- Deviations:
- yes
- Remarks:
- few details on materials and methods, substance purity not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hexadecyl (R)-12-hydroxyoleate
- EC Number:
- 233-864-4
- EC Name:
- Hexadecyl (R)-12-hydroxyoleate
- Cas Number:
- 10401-55-5
- Molecular formula:
- C34H66O3
- IUPAC Name:
- hexadecyl (R)-12-hydroxyoleate
- Details on test material:
- - Name of test material (as cited in study report): ricinoleate de cetyle
- Analytical purity: no data
- Lot/batch No.: 2009 GL
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not required
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- One hour after patch removal, very slight erythema (score 1) was observed in 3/3 animals. At the 24-hour reading time point 2/3 rabbits showed very slight erythema and 1/3 rabbits well defined erythema (score 2), which persisted in all animals until the 72-hour reading time point. No edema was observed 1 hour after patch removal. From 24 hours until at least 72 hour after patch removal, 1/3 rabbits showed very slight edema (score 1). One animal also showed slight edema at the 72-hour reading time point only, while 1/3 had no edema at any time point. No skin irritation scores were registered after the 72-hour reading time point, but all skin irritation effects were reported to have cleared completely by day 7 of the observation period. For further details see Table 1 under 'Any other information on results incl. tables'.
Any other information on results incl. tables
Table 1: individual skin irritation scores
Observation time |
Rabbit No. |
|||||
|
1 |
2 |
3 |
|||
|
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
1 |
0 |
1 |
0 |
1 |
0 |
24 h |
1 |
0 |
2 |
1 |
1 |
0 |
48 h |
1 |
0 |
2 |
1 |
1 |
0 |
72 h |
1 |
0 |
2 |
1 |
1 |
1 |
Mean value 24 + 48 + 72 h |
1.00 |
0 |
2.00 |
1.00 |
1.00 |
0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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