Registration Dossier
Registration Dossier
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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.
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