Registration Dossier
Registration Dossier
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EC number: 203-868-0 | CAS number: 111-42-2
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:
- other: Basic data provided
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- BASF-Test (Patch-Test)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2,2'-iminodiethanol
- Details on test material:
- - Name of test material (as cited in study report): Diethanolamine, Substance-No. XVII/144 (pure) and XVII/146 (technical grade)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 2.7 - 3.65 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 2 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 1, 5, 15 min and 20h
- Observation period:
- 8 days
- Number of animals:
- 2 animals for 20 h experiment and
2 animals for 1, 5, 15 min experiment - Details on study design:
- - Area of exposure: shaved skin of the back
- % coverage: patch test, otherwise no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol concentrated and lutrol diluted in water (50%)
- Time after start of exposure: 1, 5, 15 min, respectively
SCORING SYSTEM: The original scoring system was converted into Draize scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: at substance removal
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: anaemic areas
- Irritation parameter:
- erythema score
- Remarks:
- 20h treatment
- Basis:
- animal #2
- Time point:
- other: at substance removal
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 20h treatment
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: anaemic areas
- Irritation parameter:
- erythema score
- Remarks:
- 20 h treatment
- Basis:
- animal #2
- Time point:
- other: 48 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pergamentry red-yellowish necrosis
- Irritation parameter:
- erythema score
- Remarks:
- 20 h treatment
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: spotted appearance
- Irritation parameter:
- erythema score
- Remarks:
- 20h treatment
- Basis:
- animal #1
- Time point:
- other: 8 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: strong desquamation
- Irritation parameter:
- erythema score
- Remarks:
- 20h treatment
- Basis:
- animal #2
- Time point:
- other: 8 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: strong desquamation
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: at substance removal
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #2
- Time point:
- other: at substance removal
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #2
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 20 h treatment
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no difference in the erythema and edema scores following treatment with DEA pure (XVII/144) and DEA technical grade (XVII/146).
Any other information on results incl. tables
Readings |
Animal |
Exposure period: 1 min |
||
Erythema |
Edema |
Additional findings |
||
24 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
7 d |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24, 48, 72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24, 48, 72 h |
1-2 |
0 |
0 |
|
Readings |
Animal |
Exposure period: 5 min |
||
Erythema |
Edema |
Additional findings |
||
24 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
7 d |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24, 48, 72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24, 48, 72 h |
1-2 |
0 |
0 |
|
Readings |
Animal |
Exposure period: 15 min |
||
Erythema |
Edema |
Additional findings |
||
24 h |
1 |
1 |
0 |
|
2 |
1 |
0 |
||
48 h |
1 |
1 |
0 |
|
2 |
1 |
0 |
||
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
8d |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24, 72 h |
1 |
0.66 |
0 |
|
2 |
0.66 |
0 |
||
Mean 24, 48, 72 h |
1-2 |
0.66 |
0 |
|
Readings |
Animal |
Exposure period: 20 hours |
||
Erythema |
Edema |
Additional findings |
||
24 h |
1 |
3 |
2 |
anaemic areas |
2 |
3 |
2 |
||
48 h |
1 |
3 |
2 |
anaemic areas |
2 |
3 |
2 |
||
72 h |
1 |
0 |
0 |
pergamentry red-yellowish necrosis |
2 |
2 |
0 |
spotted appearance |
|
8d |
1 |
0 |
0 |
strong desquamation |
2 |
0 |
0 |
strong desquamation |
|
Mean 24, 72 h |
1 |
2 |
1.33 |
|
2 |
2 |
1.33 |
||
Mean 24, 48, 72 h |
1-2 |
2 |
1.33 |
|
In all animals a slight irritation (reddening) is observed immediately after substance removal. It is unclear if this reddening is substance related or might result from the treatment precedure (patch removal and washing with lutrol).
Applicant's summary and conclusion
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.
