Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-919-7 | CAS number: 111-90-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 20 February 1996 to 14 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to guideline protocol
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethanol
- EC Number:
- 203-919-7
- EC Name:
- 2-(2-ethoxyethoxy)ethanol
- Cas Number:
- 111-90-0
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report):Transcutol; 03503B6001
- Physical state:colourless liquid
- Analytical purity:considered 100% for the study
- Lot/batch No.:15809
- Storage condition of test material:at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: E.S.D. Romans, 01400 Chatillon-sur-Chalaronne, France
- Age at study initiation: adult about 3 months old
- Weight at study initiation: 2-3kg
- Housing:individually housed in stainless steel cages
- Diet (e.g. ad libitum):about 150g/animal/day of pelleted complete rabbit diet (Diet reference 112 C-10-Usine d'Alimentation Rationnelle, Villemoisson, 91360 Epinay-sur-Orge, France)
- Water (e.g. ad libitum):ad libitum, mains.
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19+/-3C
- Humidity (%):>=45
- Air changes (per hr):at least 12
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From:March 4, 1996 To:March 7, 1996
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1ml into the inferior conjunctival sac of the right eye
- Duration of treatment / exposure:
- 24 hours. After this period, the possible presence of corneal erosion was evaluated using fluorescein which would be eliminated with lukewarm tap water.
- Observation period (in vivo):
- 1hr, 24hr, 48hr, and 72hr after instillation
- Number of animals or in vitro replicates:
- 3 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
- Time after start of exposure:not applicable
SCORING SYSTEM: Graded numerical scale of the lesions observed at 24, 48 and 72 hours Conjunctiva (Chemosis, redness), Iris (Congestion), Cornea (Degree of opacity)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- slight irritant
- Other effects:
- no mortality was observed
Any other information on results incl. tables
Table 1. Individual values for each type of lesion obtained:
|
|
Rabbit # |
1hr |
24hrs |
48hrs |
72hrs |
Mean 24+48+72hrs |
Conjunctiva |
Chemosis |
1 |
0 |
1 |
0 |
0 |
0.33 |
2 |
1 |
0 |
0 |
0 |
0.00 |
||
3 |
1 |
0 |
0 |
0 |
0.00 |
||
Redness |
1 |
1 |
1 |
0 |
0 |
0.33 |
|
2 |
1 |
1 |
0 |
0 |
0.33 |
||
3 |
2 |
1 |
0 |
0 |
0.33 |
||
Iris |
Congestion |
1 |
1 |
0 |
0 |
0 |
0.00 |
2 |
1 |
1 |
1 |
0 |
0.67 |
||
3 |
1 |
1 |
1 |
0 |
0.67 |
||
Cornea |
Opacity |
1 |
0 |
0 |
0 |
0 |
0.00 |
2 |
0 |
0 |
0 |
0 |
0.00 |
||
3 |
0 |
0 |
0 |
0 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test substance is mildly irritating to the eyes under the conditions of this study but not sufficient to warrant classification under EU directives or regulations
- Executive summary:
In a well conducted guideline and GLP study, 0.1ml of 2 -(2 -ethoxyethoxy)ethanol was instilled into the right eye of three New Zealand White male rabbits. Conjunctival, iris and corneal scores were determined at 1hr, 24hrs, 48hrs and 72hrs after administration. Mild transient iritis and conjunctival effects were observed in some animals but no corneal response. All symptoms reversed within 72 hours. The test substance is considered mildly irritanting to eyes under the conditions of this study but does not warrant classification as an eye irritant.
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.
