Registration Dossier
Registration Dossier
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EC number: 855-895-8 | CAS number: 212908-67-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- June-2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- only basic information given, four animal was tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- screening test with four animal
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-hydroxy-N-[(2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl]benzamide
- EC Number:
- 855-895-8
- Cas Number:
- 212908-67-3
- Molecular formula:
- C27H47NO5
- IUPAC Name:
- 2-hydroxy-N-[(2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl]benzamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch: K928/99/1/1/39
Purity: 97.4%
Constituent 1
Test animals
- Species:
- guinea pig
- Details on test animals or test system and environmental conditions:
- no information available
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: Propylene Glycol
- Controls:
- not specified
- Amount / concentration applied:
- 2, 5, 10, and 20%
- Duration of treatment / exposure:
- 2 hours
- Observation period:
- 24 and 48 hours
- Number of animals:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- no information available
SCORING SYSTEM:
- according to OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 31
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 20% and 10%
- Irritation parameter:
- edema score
- Basis:
- animal: 31
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 20% and 10%
- Irritation parameter:
- erythema score
- Basis:
- animal: 32
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 20% and 10%
- Irritation parameter:
- edema score
- Basis:
- animal: 32
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 20% and 10%
- Irritation parameter:
- erythema score
- Basis:
- animal: 33
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 5% and 2%
- Irritation parameter:
- edema score
- Basis:
- animal: 33
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 5% and 2%
- Irritation parameter:
- erythema score
- Basis:
- animal: 34
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 5% and 2%
- Irritation parameter:
- edema score
- Basis:
- animal: 34
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- test conc. 5% and 2%
- Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not irritating to the skin of guinea pigs.
- Executive summary:
Skin irritation potential of Salicyloyl Phytosphingosine in a priliminary irritation study with guinea pigs.
Observations were made after 48, and 72 h.
No reactions were seen; erythema and edema scores after 24 and 48 h were 0.
Based on the results of this test, Salicyloyl Phytosphingosine is not irritating to skin.
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