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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 402-600-1 | CAS number: 765-12-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Triethylenglykoldivinylether, Substance number 96/283
- Analytical purity: ABOUT 98.4 % (GO)
- Physical state: LIQUID, ACHROMATIC, CLEAR
- Lot/batch No.: 3401/95-09
- Stability under test conditions: The stability of the test substance in olive oil DAB 10 for a time period of 4 hours was confirmd by analysis.
- Storage condition of test material: 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: Harlan Winkelmann GmbH (Interfauna, United Kingdom)
- Age at study initiation: young adult animals
- Weight at study initiation: male: 2.99 kg; females: 3.08 and 3.91 kg
- Housing: single
- Diet: Kliba-Labordiaet 341, Klingenthalmühle AG Kaiseraugst, Switzerland, about 130 g per animal per day.
- Water: tap water, about 250 mL per animal per day.
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL unchanged - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ROUTE OF APPLICATION: single application to the conjunctival sac of the right eyelid.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The substance was washed out with tap water about 24 hours after application (before 24 hour reading).
- Time after start of exposure: 24 hours
READINGS: 1, 24, 48, and 72 hours after application
SCORING SYSTEM:
According to OECD Guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Other effects:
- Discharge: all animals exhibit score 2 one hour after treatment. The effect was revesible within 24 hours.
Any other information on results incl. tables
The findings were reversible in all animals within 48 hours after application; thus, the study was terminated after 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen triethylenglycoldivinylether is non irritating to the eye.
- Executive summary:
The potential of Triethylenglycoldivinylether to cause damage to the conjunctiva, iris or cornea was assessed in 3 white New Zealand rabbits, subjected to a single ocular application of 0.1 ml of the test substance. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.3 for conjunctivae redness. The findings were reversible in all animals within 48 hours after application; thus the study was terminated after 72 hours. Under the test conditions chosen and considering the described findings, triethylenglycoldivinylether does not give indication of an irritant property to the eye.
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.
