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.
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.24, 2.77, 3.28 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- not applicable, because test substance remained in the eye and was not washed out
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: according to OECD Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1-3
- Time point:
- 24/48/72 h
- Score:
- 2.55
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- other: cornea area
- Basis:
- mean
- Remarks:
- 1-3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1-3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1-6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1-3
- Time point:
- 24/48/72 h
- Score:
- 2.89
- Max. score:
- 3
- Reversibility:
- not reversible
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
op |
ar |
red |
ch |
di |
||||
1 h |
1 |
2 |
4 |
2 |
3 |
2 |
3 |
PC |
2 |
2 |
4 |
2 |
3 |
3 |
2 |
PC |
|
3 |
1 |
4 |
1 |
3 |
2 |
3 |
PC |
|
24 h |
1 |
2 |
4 |
2 |
3 |
3 |
3 |
E, PC |
2 |
2 |
4 |
2 |
3 |
3 |
2 |
E, PC |
|
3 |
2 |
4 |
2 |
3 |
2 |
2 |
E, Pv, Na |
|
48 h |
1 |
2 |
4 |
2 |
3 |
3 |
3 |
SI/Na |
2 |
2 |
4 |
2 |
3 |
3 |
2 |
E, PC, Na |
|
3 |
2 |
4 |
2 |
3 |
3 |
2 |
E, PC, Na |
|
72 h |
1 |
4 |
4 |
2 |
3 |
3 |
3 |
S1/Na |
2 |
4 |
4 |
2 |
3 |
3 |
3 |
E, Na |
|
3 |
3 |
4 |
2 |
3 |
3 |
3 |
E, Pv, Na |
|
Mean 24 -72 h |
1 |
2.66 |
4 |
2 |
3 |
3 |
3 |
|
2 |
2.66 |
4 |
2 |
3 |
3 |
2.33 |
|
|
3 |
2.33 |
4 |
2 |
3 |
2.66 |
2.33 |
|
|
Mean 24-72 h |
1-3 |
2.55 |
4 |
2 |
3 |
2.89 |
2.55 |
|
Symbols:
S1: reading not possible due to pus formation
E: pus formation
PC: Pupil contracted
Na: scars at the eyelids
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.
