Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-415-0 | CAS number: 13360-63-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-08-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (corrosivity could be predicted from physico-chemical properties; intact and abraded skin tested)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Method: other: acc. to US Fed. Reg. 244 (1972)
- GLP compliance:
- no
Test material
- Reference substance name:
- Butyl(ethyl)amine
- EC Number:
- 236-415-0
- EC Name:
- Butyl(ethyl)amine
- Cas Number:
- 13360-63-9
- Molecular formula:
- C6H15N
- IUPAC Name:
- butyl(ethyl)amine
- Details on test material:
- - Name of test material (as cited in study report): N-Ethyl-N-Butylamine [CAS No. 13360-63-9], not further specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3
- Air changes (per hr): 20
- Photoperiod (10 hrs dark / 14 hrs light):
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 96 hrs
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 50 mm diameter
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hrs
SCORING SYSTEM: according to Draize (1959)
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 5.9
Any other information on results incl. tables
The test substance produced severe erythema (score 4 ; readings at 4, 24, and 48 hrs) and moderate edema (score 2; readings at 4, 24, and 48 hrs) in all animals. All test sites had become necrotic at the 4 hour reading.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The intact rabbit skin (six New Zealand White) had become necrotic after a 4-hour contact to Butylethylamine (neat, 500 mg under occlusive dressing) (Safepharm, 1980).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
