Registration Dossier
Registration Dossier
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EC number: 227-410-4 | CAS number: 5831-80-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N-dibutyloleamide
- EC Number:
- 227-410-4
- EC Name:
- N,N-dibutyloleamide
- Cas Number:
- 5831-80-1
- Molecular formula:
- C26H51NO
- IUPAC Name:
- N,N-Dibutyloleamide
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical Factory Dr' K' Thomae88400 Biberach
- Weight at study initiation: 2,6-3,1 kg
- Housing: separate
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50+/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 05 ml
- Concentration (if solution): 100 % - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: semiocclusive surgical plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the resutts of this study Ölsäuredibutylamid (70%) is irritating io skin
- Executive summary:
Testing of undiluted Ölsäuredibutylamid (70%) for primary dermal irritation on intact skin under semi-occlusive conditions in the rabbit showed that the substance is irritating to skin.
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