Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Lack of individual data.

Data source

Reference
Reference Type:
publication
Title:
CHEMICAL BURNS OF THE RABBIT CORNEA
Author:
Carpenter, C.P. and Smyth, H.F.
Year:
1946
Bibliographic source:
Am J Ophthalmol. 29(11):1363-72

Materials and methods

Principles of method if other than guideline:
Treatment of the rabbit eye with differing volumes of the undiluted test substance.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene diformate
EC Number:
211-077-7
EC Name:
Ethylene diformate
Cas Number:
629-15-2
Molecular formula:
C4H6O4
IUPAC Name:
2-(formyloxy)ethyl formate
Details on test material:
- Name of test material (as cited in study report): Ethylene glycol diformate
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbit, not further specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.02 and 0.005 mL

Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
Reading time point: 18-24 h
Number of animals or in vitro replicates:
5
Details on study design:
SCORING SYSTEM: The individual numerical scores of each eye treated with a given volume or concentration of a chemical were added together and then divided by the number of eyes to obtain the score of the injury caused by the treatment. The level of 5 was selected as representative of severe injury. This figure corresponded to necrosis, visible after staining and covering about 3/4 of the surface of the cornea; or a more severe necrosis covering a smaller area.
See Tables 1 and 2 under "Any other information on materials and methods incl. tables".

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: injury grade
Basis:
mean
Remarks:
out of 5 eyes
Time point:
other: 18-24 h
Score:
5
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: 0.005 mL of the undiluted test substance
Irritation parameter:
other: injury grade
Basis:
mean
Remarks:
out of 5 eyes
Time point:
other: 18 - 24 h
Score:
> 5
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: 0.02 mL of the undiluted test substance

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye damage 1, H318
DSD: C, R34