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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-963-7 | CAS number: 112-36-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(2-ethoxyethyl) ether
- EC Number:
- 203-963-7
- EC Name:
- Bis(2-ethoxyethyl) ether
- Cas Number:
- 112-36-7
- Molecular formula:
- C8 H18 O3
- IUPAC Name:
- 1-ethoxy-2-(2-ethoxyethoxy)ethane
- Reference substance name:
- Diethylene Glycol Diethyl Ether
- IUPAC Name:
- Diethylene Glycol Diethyl Ether
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material (as cited in study report): DEGD, Bis (2-ethoxyethyl) ether
- Substance type: Solvent for toner
- Physical state: Colourless liquid
- Analytical purity:99.95 (GC%)
- Lot/batch No.:2E09WA
- Expiration date of the lot/batch:31 December 2012
- Stability under test conditions:
- Storage condition of test material: Refrigerator (ca.4C) in the dark
- Other:
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: respected breeders
- Age at study initiation:36 or 39 weeks
- Weight at study initiation:3.80 to 4.38 kg
- Housing: housed individually in a plastic cage with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:21 or 22 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C):16 to 20°C
- Humidity (%):40 to 70%.
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12hrs/12hrs
IN-LIFE DATES: From: 26 October 2012 To: 15 November 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- The eyelids were then gently held together for one second before releasing. The substance was not removed and the eyes were not washed.
- Observation period (in vivo):
- Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours and eight days after treatment
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: according to the system of Kay and Calandra (1962)
TOOL USED TO ASSESS SCORE: An ophthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: Redness of conjunctiva - Mean score following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Redness of conjunctiva - mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Redness of conjunctiva - mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1, 24h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1, 24h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Injection of the conjunctival blood vessels and very slight or slight chemosis was evident in all animals during the first 24 hours following instillation; in two cases the conjunctival injection persisted throughout the first 72 hours after instillation. Slight or moderate discharge was apparent in all animals one hour after instillation. The treated eye of one animal was overtly normal by 48 hours after instillation and in the remaining two animals on Day 8. However, DEDG did not require labelling in accordance with European Commission regulation 1272/2008.
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.
