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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-057-1 | CAS number: 102-81-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (BASF test, no details on animal husbandry, occlusive conditions, exposure period up to 20 hours)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-dibutylaminoethanol
- EC Number:
- 203-057-1
- EC Name:
- 2-dibutylaminoethanol
- Cas Number:
- 102-81-8
- Molecular formula:
- C10H23NO
- IUPAC Name:
- 2-(dibutylamino)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Dibutylaethanolamin
- Analytical purity: >99%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.55, 3.7 kg
No further data.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- 1, 5 and 15 min and 20 h
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (conc.) and Lutrol/water (1:1).
- Time after start of exposure: Immediately after 1, 5 and 15 min exposure.
SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: 20 h exposure
- Time point:
- other: 24 h - 48 h -72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey-brown necrosis was observed in the 20 h exposure experiment 24 hours after application. Necrosis still was evident at the end of the observation period of 8 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 and 5 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- 15 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days in one of the two animals
- Irritation parameter:
- edema score
- Remarks:
- 1, 5 and 15 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Mean erythema score after 24, 48 and 72 h (animal 1/2)
Exposure time |
24 h |
48 h |
72 h |
mean |
1 min |
0/0 |
0/0 |
0/1 |
0/0.3 |
5 min |
0/0 |
0/0 |
0/1 |
0/0.3 |
15 min |
1/0 |
0/1 |
0/2 |
0.3/1 |
20 h |
grey-brown necrosis with reddened surrounding/ brown necrosis with reddened surrounding |
grey-brown necrosis with reddened surrounding/ brown necrosis with reddened surrounding |
grey-brown necrosis with reddened surrounding/ brown necrosis with reddened surrounding |
- /- |
Mean edema score after 24, 48 and 72 h (animal 1/2)
Exposure time |
24 h |
48 h |
72 h |
mean |
1 min |
0/0 |
0/0 |
0/0 |
0/0 |
5 min |
0/0 |
0/0 |
0/0 |
0/0 |
15 min |
0/0 |
0/0 |
0/0 |
0/0 |
20 h |
grey-brown necrosis with reddened surrounding/ brown necrosis with reddened surrounding |
grey-brown necrosis with reddened surrounding/ brown necrosis with reddened surrounding |
grey-brown necrosis with reddened surrounding/ brown necrosis with reddened surrounding |
- /- |
20 h exposure: necrosis was accompanied with bleedings.
The findings after 20 h occluded application were used for evaluation. The conclusion may be more stringent than one derived from a 4 h semi occluded application required by the current OECD guideline.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
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.
