Registration Dossier
Registration Dossier
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EC number: 272-729-4 | CAS number: 68910-05-4 A complex residuum from the fractionation of the reaction products of 2-aminoethanol with ammonia to remove piperazine. It may contain such compounds as 2-[(2-aminoethyl)amino]ethanol, (aminoethyl)piperazine, (hydroxyethyl)piperazine.
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: Well documented study report, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethanol, 2-amino-, reaction products with ammonia, by-products from
- EC Number:
- 272-729-4
- EC Name:
- Ethanol, 2-amino-, reaction products with ammonia, by-products from
- Cas Number:
- 68910-05-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Ethanol, 2-amino-, reaction products with ammonia, by-products from
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): DEA, by-products
- no further data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.78, 2.63, 2.88, 2.80, 2.73, 2.56 kg
- Housing: individual, stainless steel cages without beddings
- Diet Ovator Solikanin, Muskator-Werke, Düsseldorf, Germany; 130 g /day
- Water Tap water 250 ml/day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 6 (2 males, 4 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol 50% diluted in water
- Time after start of exposure: 4 hour
SCORING SYSTEM:
according to OECD Draize scores
Readings: 30-60 min, 24 h, 48 h, 72 h, 8 days after substance removal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1-6
- Time point:
- 24/48/72 h
- Score:
- 2.27
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1-6
- Time point:
- 24/48/72 h
- Score:
- 1.06
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
Any other information on results incl. tables
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
4 h |
1 |
2 |
1 |
R:U/OE:U |
2 |
2 |
1 |
R:U/OE:U |
|
3 |
2 |
1 |
R:U/OE:U/HE |
|
4 |
2 |
1 |
R:U/OE:U |
|
5 |
2 |
2 |
R:U/OE:U/HE |
|
6 |
1 |
0 |
R:U |
|
24 h |
1 |
2 |
1 |
R:U/OE:U |
2 |
2 |
1 |
R:U/OE:U |
|
3 |
4 |
2 |
N/OE:U |
|
4 |
2 |
1 |
R:U/OE:U |
|
5 |
2 |
1 |
R:U/OE:U/HE |
|
6 |
1 |
0 |
R:U |
|
48 h |
1 |
2 |
1 |
HE |
2 |
3 |
1 |
R:U/OE:U/HE |
|
3 |
4 |
2 |
N |
|
4 |
2 |
1 |
|
|
5 |
2 |
1 |
R:U/OE:U/HE |
|
6 |
1 |
0 |
R:U |
|
72 h |
1 |
2 |
1 |
HE |
2 |
3 |
2 |
HE |
|
3 |
4 |
2 |
N |
|
4 |
2 |
1 |
|
|
5 |
2 |
1 |
R:U/OE:U/HE |
|
6 |
1 |
0 |
R:U |
|
8 d |
1 |
1 |
0 |
S/+ |
2 |
1 |
0 |
S/+ |
|
3 |
4 |
2 |
N:TI/+ |
|
4 |
1 |
0 |
S/+ |
|
5 |
4 |
1 |
N:OB/+ |
|
6 |
1 |
0 |
S/+ |
|
Mean 24, 48, 72 h |
1 |
2 |
1 |
|
2 |
2.66 |
1.33 |
|
|
3 |
4 |
2 |
|
|
4 |
2 |
1 |
|
|
5 |
2 |
1 |
|
|
6 |
1 |
0 |
|
|
Mean 24, 48, 72 h |
1-6 |
2.27 |
1.055 |
|
Symbols:
HE haemorrhagia
N necrosis
N:TI necrosis (deep)
N:OB necrosis (superficial)
OE:U oedema exceeding beyond area of exposure
S desquamation
+ pathologically confirmed
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
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