Registration Dossier
Registration Dossier
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EC number: 275-276-0 | CAS number: 71216-01-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- less reporting details on test animals and test item. More stringent exposure regime
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 187, § 1500.41, 1973 (Draize test)
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N''-naphthalene-1,5-diylbis[N'-[3-[(2-ethylhexyl)oxy]propyl]urea]
- EC Number:
- 275-276-0
- EC Name:
- N,N''-naphthalene-1,5-diylbis[N'-[3-[(2-ethylhexyl)oxy]propyl]urea]
- Cas Number:
- 71216-01-8
- Molecular formula:
- C34H56N4O4
- IUPAC Name:
- N',N'''-naphthalene-1,5-diylbis(1-{3-[(2-ethylhexyl)oxy]propyl}urea)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Mean body weight: 3.0 kg
The animals were offered a standardized animal laboratory diet.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- other: paraffin oil
- Controls:
- other: untreated skin
- Amount / concentration applied:
- 0.5 g of a 50% aqueous test substance preparation in paraffin oil
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days
- Number of animals:
- 6
- Details on study design:
- Application area: 2.5 x 2.5 cm
Application site: back
The test substance was not washed off.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.75
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.15
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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