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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Toxicity of Ethylene Oxide Determined on Experimental Animals.
Author:
Hollingsworth, R.L., Rowe, V.K., Oyen, F., McColister, D.D., Spencer, H.C.
Year:
1956
Bibliographic source:
A.M.A. Archives of Industrial Health 13, 217-227

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Occlusive application to shaved rabbit skin for periods of 1 - 60 minutes followed for an observation period of 6-7 days.
GLP compliance:
no
Remarks:
pre-GLP study

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:
- physical appearance: liquidSOURCE OF TEST MATERIAL
- Purity: 97.0 - 98.6%
- Impurities: Maximum found by MS analysis were 2.3% air and 0.7% acetylene.

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
intact skin only
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
10% and 50% aqueous solutions
Duration of treatment / exposure:
1 - 60 min
Observation period:
6 - 7 days
Number of animals:
no data
Details on study design:
Small pads of cotton were moistened with aqueous solutions of ethylene oxide and applied to the intact shaved abdominal skin of immobilized rabbits under a saran plastic cover for periods of time ranging from 1 - 60 minutes. The animals were observed for 6 - 7 days following exposure.

Results and discussion

In vivo

Results
Irritation parameter:
other: hyperemia, edema and scar formation
Basis:
mean
Time point:
other: 6 minutes
Remarks on result:
other: hyperemia and edema resulted when the duration of skin contact was 6 minutes or longer. The severer exposures resulted in scar formation. The intensity of response was roughly proportional to the length of exposure time and concentration.
Irritant / corrosive response data:
Hyperemia and edema resulted when the duration of skin contact was 6 minutes or longer. The longer exposures resulted in scar formation. The intensity of response was roughly proportional to the length of exposure time and the concentration.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Severe injury to the skin was described as the result of contact, in particular with aqueous solutions of ethylene oxide.
Executive summary:

The skin irritation potential of the test substance was investigated using more than a single rabbit exposed to concentrations in aqueous solutions of 10 and 50%. Small pads of cotton were moistened with the test substance and applied to the intact shaved abdominal skin of immobilized rabbits under a saran plastic cover for 1 minute to 60 minutes. Rabbits were observed for six to seven days following exposure. Hyperemia and edema resulted when the duration of the skin contact was six minutes or longer. The intensity of response was roughly proportional to the length of exposure time and the concentration. Scar formation was reported and thus, the test substance was concluded to be corrosive.