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.
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