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Human skin reaction to ethylene oxide
The Journal of Laboratory and Clinical Medicine
|November 1, 1981
Summary
Ethylene oxide (EO) gas retained in medical materials can cause skin irritation. Studies show approximately 1000 ppm of EO in slow-releasing materials for 4+ hours is the lowest level to irritate skin in non-sensitized individuals.
Area of Science:
- Medical Device Sterilization
- Toxicology
- Dermatology
Background:
- Ethylene oxide (EO) is widely used for sterilizing hospital materials.
- Improperly aerated materials can retain EO, leading to skin irritation.
- Understanding EO's toxicological threshold is crucial for patient safety.
Purpose of the Study:
- To determine the EO concentration and contact duration causing adverse skin reactions.
- To investigate the role of EO by-products (EC, EG) in skin reactions.
- To establish the minimum EO level causing skin irritation in humans.
Main Methods:
- Human volunteers applied patches containing EO or its by-products (EC, EG) to their skin.
- Patches were removed at 1-8 hour intervals for reaction observation.
- Different patch materials varied in EO retention properties.
Main Results:
- Skin reactions correlated with the total dose of EO received.
- Materials with rapid EO release (fabric, rubber) showed few reactions, even at 5000 ppm.
- Slow-releasing materials (PVC, petrolatum on Webril) caused reactions at ~1000 ppm after 4-8 hours.
- One subject showed sensitivity to ~100 ppm EO.
Conclusions:
- Ethylene oxide (EO), not its by-products, is the primary toxic agent.
- The lowest EO level causing skin irritation in non-sensitized subjects is approximately 1000 ppm.
- Prolonged skin contact (4+ hours) with slow-releasing EO materials increases irritation risk.