Registration Dossier
Registration Dossier
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EC number: 224-929-8 | CAS number: 4559-86-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- According to Federal Register 38, No. 187, § 1500.41
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetrabutylurea
- EC Number:
- 224-929-8
- EC Name:
- Tetrabutylurea
- Cas Number:
- 4559-86-8
- Molecular formula:
- C17H36N2O
- IUPAC Name:
- 1,1,3,3-tetrabutylurea
- Test material form:
- other: liquid
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and scarified skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- no data
- Duration of treatment / exposure:
- not specified
- Observation period:
- up to 8 days
- Number of animals:
- 3
- Details on study design:
- According to Federal Register 38, No. 187, § 1500.41
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 5.42
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 8 days
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 1,1,3,3-tetrabutylurea was highly skin irritating in rabbits
- Executive summary:
Possible skin irritating properties of 1,1,3,3-tetrabutylurea were tested in a study with 3 rabbits according to Federal Register 38, No. 187, § 1500.41. With a primary dermal irritation index (PDII) of ca. 5.4 the substance was highly irritating.
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