Registration Dossier
Registration Dossier
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EC number: 224-929-8 | CAS number: 4559-86-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- 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
- 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- According to Federal Register 38, No. 187, § 1500.42
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- no data
- Duration of treatment / exposure:
- not specified
- Observation period (in vivo):
- up to 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- According to Federal Register 38, No. 187, § 1500.42
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3.56
- Max. score:
- 110
- Reversibility:
- fully reversible within: 3 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 1,1,3,3-tetrabutylurea was not eye irritating in rabbits
- Executive summary:
Possible eye irritating properties of 1,1,3,3-tetrabutylurea were tested in a study with 3 rabbits according to Federal Register 38, No. 187, § 1500.42. With an overall irritation score of 3.56 the substance was not eye irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
Possible eye irritating properties of 1,1,3,3-tetrabutylurea were tested in a study with 3 rabbits according to Federal Register 38, No. 187, § 1500.42. With an overall irritation score of 3.56 the substance was not eye irritating.
Effects on skin irritation/corrosion: highly irritating
Justification for classification or non-classification
Conclusion on skin irritation: 1,1,3,3-tetrabutylurea was highly skin irritating in rabbits and should be labelled accordingly.
Conclusion on eye irritation: 1,1,3,3-tetrabutylurea was not eye irritating in rabbits. Therefore, there is no need for classification and labelling.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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