Registration Dossier

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.