Registration Dossier
Registration Dossier
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EC number: 306-522-8 | CAS number: 97281-23-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Limited documentation, concentration and details on test substance 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)
- Deviations:
- yes
- Remarks:
- (limited documentation (type of dressing, treatment of skin prior to substance application), concentration of test substance not given, lack of details on test substance)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-hydroxyethyl stearate
- EC Number:
- 203-886-9
- EC Name:
- 2-hydroxyethyl stearate
- Cas Number:
- 111-60-4
- Molecular formula:
- C20H40O3
- IUPAC Name:
- 2-hydroxyethyl stearate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 1, 24, 48 and 72 h
Observation period: 72 h - Number of animals:
- 3 males
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:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight local skin reactions visible as erythema graded with score 1 were observed in all test animals 1 hour after patch removal. 24 hrs after patch removal, slight erythema (grade 1) were still visible in 2/3 animals. The erythema were fully reversible 48 hrs after patch removal. Oedema were not observed in any test animal.
- Other effects:
- No other effects are reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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