Registration Dossier
Registration Dossier
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EC number: 423-300-7 | CAS number: 128554-52-9
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 423-300-7
- EC Name:
- -
- Cas Number:
- 128554-52-9
- Molecular formula:
- Molecular formula varies for each reaction product. See section 1.2 for the molecular formula for each identified reaction product.
- IUPAC Name:
- 12-hydroxy-N-({3-[(12-hydroxyoctadecanamido)methyl]phenyl}methyl)octadecanamide
- Reference substance name:
- AMIDE#71
- IUPAC Name:
- AMIDE#71
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: AMIDE#71
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM:
Immediately following removal of the semi-occlusive patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 1)
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 2)
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 3)
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 1)
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 2)
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 3)
- Time point:
- other: Mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects at any observation
- Irritant / corrosive response data:
- No irritation was observed at any time point and all scores for erytheam and edema were 0 after 72 hours.
- Other effects:
- None (no signs of toxicity).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not a skin irritant and should not be classified as a skin irritant.
- Executive summary:
Skin irritation
The test substance was assessed for skin irritation according to EU Method B4.
No irritation was observed after a 4 hour exposure in any animal, at any time point and all scores for erythema and edema were 0 after 72 hours.No signs of toxicity were noted either.
The substance is not a skin irritant.
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