Toxicity and residue analysis
Toxicity evaluation of the sterilant concentrate and use dilution were done to determine the safety risks associated with human contact. The sterilant concentrate was found to be caustic to skin and eyes, but only moderately toxic if orally ingested. The sterilant concentrate package was designed to prevent operator exposure to the concentrate.
The use dilution underwent acute oral and dermal toxicity testing and ocular irritation testing. The use dilution has a nearly neutral pH and is nontoxic by oral or dermal administration, and has no caustic effect on the skin.
The amount of sterilant residue which may remain on medical devices after processing also was studied. After replicate sterilization cycles and exposures to use dilution and the sterile rinses, extracts were taken for study. No evidence was found that the cycles resulted in any cumulative increase in residues, and no PA could be detected.
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