Registration Dossier
Registration Dossier
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: 213-195-4 | CAS number: 929-06-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
- Principles of method if other than guideline:
- BASF-Test, see details in remarks on results.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2-aminoethoxy)ethanol
- EC Number:
- 213-195-4
- EC Name:
- 2-(2-aminoethoxy)ethanol
- Cas Number:
- 929-06-6
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-(2-aminoethoxy)ethan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.46 and 2.88 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 1 min, 5 min, 15 min or 20 h.
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): concentrated Lutrol and 50% Lutrol
- Time after start of exposure: 1 min, 5 min and 15 min
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- , 1 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Remarks:
- , 5 min
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: scale formation
- Irritation parameter:
- erythema score
- Remarks:
- , 15 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: necrosis
- Irritation parameter:
- erythema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: full thickness necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms
Any other information on results incl. tables
Mean erythema score after 24, 48 and 72 h (animal1/2)
| Exposure time | 24 h | 48 h | 72 h | mean |
| 1 min | 1/1 | 0/0 | 0/0 | 0.3/0.3 |
| 5 min | 1/1 | 0/1 | 0/1 | 0.3/1 |
| 15 min | 1/3 | 0/3 | 0/2 | 0.3/2.7 |
| 20 h | 2/3 | 2/3 | 3/3 | 2/3 |
Mean edema score after 24, 48 and 72 h (animal1/2)
| 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 | 0/0 | 0/0 | 0/0 | 0/0 |
The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period. The appearing necrosis is considered as a full thickness necrosis.
The original BASF grading was converted into the numerical grading according the OECD Draize system.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Corrosive
- Executive summary:
The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 h post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period.
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.
