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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Highly diluted solutions of ethylene oxide were tested.

Data source

Reference
Reference Type:
publication
Title:
Acute Ocular Toxicity for Normal and Irritated Rabbit Eyes and Subacute Ocular Toxicity for Ethlyene Oxide, Ethlyene Chlorohydrin, and Ethylene Glycol.
Author:
McDonald, T.O, Kasten, K., Hervey, R., Gregg, S., Britton, B.
Year:
1977
Bibliographic source:
Bull. Parenteral Drug. Assoc. 31, 25 - 32

Materials and methods

Principles of method if other than guideline:
Repeated ocular instillation of 0.05ml of diluted ethylene oxide to rabbit eyes with evalution after 6h, 24h and 48h
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene oxide
EC Number:
200-849-9
EC Name:
Ethylene oxide
Cas Number:
75-21-8
Molecular formula:
C2H4O
IUPAC Name:
oxirane
Specific details on test material used for the study:
Supplier: Eastman, Inc

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy male and female rabbits weighing 2 - 3 kg were utilized. All animal eyes were free of ocular lesions as detected by macroscopic and slit-lamp examination conducted just prior to use. Animals were maintained on Purina Chow and tap water, ad libitum. Animals were acclimated to laboratory conditions one week before use.

Test system

Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
0.05 ml at 10-minute intervals for 6h
Concentrations tested were 0.01%, 0.1% and 1%
Duration of treatment / exposure:
6 hours
Observation period (in vivo):
48 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test groups were so divided that each concentration of the test substance was evaluated in six irritated eyes and six normal eyes. Control groups included six normal untrated eyes, six eyes that were irritated then received the vehicle, six normal eyes which received the vehicle, and six irritated eyes which received no treatment other than being irritated with the diluted commercial shampoo.
The irritated eyes were achieved by a single instillation of 0.1 ml of the diluted shampoo. These eyes were irritated one hour prior to the initiation of the study. The time period has been noted for tabulation as 0 time and represents the examination of the irritated eyes just prior to dosing ethylene oxide or its two residues. At the time the dosing was initiated, all treated eyes received topical ocular instillation of 0.05 ml/dose at 10-minute intervals for 6 hours of the various concentrations of ethylene oxide. During this time period, the animals were restrained in boxes then were later placed (after 6 hours) in cages for subsequent examination. Ocular changes were graded at the end of six hours, at 24 hours and after 48h and were graded according to Draize and Baldwin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: 0.01% ethylene oxide (normal eye)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: 0.1% ethylene oxide (normal eye)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0.8
Max. score:
4
Remarks on result:
other: 1% ethylene oxide (normal eye)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: 0.01% ethylene oxide (irritated eye)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: 0.1% ethylene oxide (irritated eye)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0.5
Max. score:
4
Remarks on result:
other: 1% ethylene oxide (irritated eye)
Irritant / corrosive response data:
With increasing concentrations of ethylene oxide, various ocular pathologic changes were observed. The publication does not provide further information.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The maximum non-damaging concentration of ethylene oxide in physiological saline was 0.1%. Concentrations higher than 1% were not tested.

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