Abstract
SG-01 is newly developed hydrophilic wound dressing material. To evaluate the safety of SG-01, we performed a primary skin irritation test, a cumulative skin irritation test, an infracutaneous reactivity test, a skin sensitization test, and a pyrogen test. To investigate irritation of SG-01, it was applied to the intact/abraded skin of the rabbit back for 4 hours. Neither intact nor abraded skin showed any reactions. To investigate cumulative irritation, SG-01 was applied to the skin of the rabbit back for 6 hours once a day for 14 days. No dermal reactions were observed. Intracutaneous reactivities on rabbits were examined using the extracted solutions by physiological saline or sesame oil at 37°C for 72 hours. Negative reactions were obtained. A skin sensitization tests were performed by the adjuvant and patch method using guinea pigs. In SG-01 group, there were no dermal reactions, as demonstrated in the control group treated with vehicle (water for injection). A pyrogen test was performed on SG-01 using the extracted in physiological saline at 37°C for 72 hours. The results revealed the absence of pyrogen. The safety of SG-01 was ensured by the results from these studies.
