Registration Dossier
Registration Dossier
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EC number: 268-952-1 | CAS number: 68155-26-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read across approach adequate to support 7.3.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read across approach adequate to support 7.3.1 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017) - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: repeated insult patch test on humans
- Species:
- other: humans
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- other:
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- not irritant
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Test material
- Reference substance name:
- Reference substance 005
- Cas Number:
- 93-83-4
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on study design:
- Two groups of six New Zealand rabbits were used to evaluate the skin irritancy of Oleamide DEA. Each animal received a single 24-h occlusive patch containing 0.3 ml test material. Test sites were scored for erythema, eschar formation, and edema 1 and 48 h after patch removal. One group was given 70% Oleamide DEA in propylene glycol, and the other group received 5% Oleamide DEA in propylene glycol.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- ca. 3.3
- Remarks on result:
- other: 70% group
- Irritation parameter:
- erythema score
- Score:
- 3.3
- Remarks on result:
- other: 70% group
- Irritation parameter:
- edema score
- Score:
- 3.3
- Remarks on result:
- other: 70% group
- Irritation parameter:
- other: eschar formation
- Score:
- 3.3
- Remarks on result:
- other: 70% group
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 1.9
- Remarks on result:
- other: 5% group
- Irritation parameter:
- erythema score
- Score:
- 1.9
- Remarks on result:
- other: 5% group
- Irritation parameter:
- edema score
- Score:
- 1.9
- Remarks on result:
- other: 5% group
- Irritation parameter:
- other: eschar formation
- Score:
- 1.9
- Remarks on result:
- other: 5% group
Applicant's summary and conclusion
- Conclusions:
- Oleamide DEA was a mild skin irritant, and 70% Oleamide DEA was a moderate skin irritant.
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