Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study already available
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no details about test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl vinyl ether
EC Number:
203-718-4
EC Name:
Ethyl vinyl ether
Cas Number:
109-92-2
Molecular formula:
C4H8O
IUPAC Name:
ethoxyethene
Details on test material:
ethyl vinyl ether (EVE), no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: GAUKLER ; OFFENBACH (FRG)
- Age at study initiation: no data
- mean weight at study initiation: 3.4 (males) and 3.2 kg (female)
- Housing: singly
- certified diet and tap water ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
no washing
Observation period (in vivo):
Eye reactions were examined after 1, 24, 48, and 72 h after application
Number of animals or in vitro replicates:
3 (two male and one female)
Details on study design:
0.1 ml of undiluted TS was placed into the conjunctival sack of the rabbit's eye. The substance was not washed out. Effects were scored according to the table of Draize contained in the OECD TG 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: no effects 48 h after application; no effects on iris and cornea at any reading
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: no effects 48 h after application
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no effects 48 h after application
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no effects 48 h after application
Irritant / corrosive response data:
No corneal opacity was noted in any of the animals at any reading, i.e. the mean score = 0 for all readings in all animals.
Iritis: no effect in any animal at any time, therefore mean score = 0.
Conjunctivae: mild and well-defined reddening, discharge and swelling was noted at 1 hour and to a lesser degree at 24 hrs post treatment. No effect was noted at 48 and 72 hrs post treatment.
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
In three White Vienna rabbits the instillation of 0.1 mL of the undiluted test substance into the conjunctival sac of one eye caused reddening (grade 1 - 2) and slight swelling (grade 1) 1 & 24 hours after application (no washing). The findings cleared up 48 hours after application. No effects were noted on cornea or iris.