THE STUDY OF ALLERGENIC AND GENOTOXIC EFFECTS OF THE MEDICAL DEVICE «RESORBABLE COLLAGEN MATERIAL COLLOST®, GEL» IN THE PRE-CLINICAL MODELS <i>IN VIVO</i>

Abstract

Allergenic and genotoxic effects of the medical device «Resorbable collagen material "COLLOST® gel» were studied in laboratory animals. It was shown than immediate-type hypersensitivity reaction is not detected in mice by the cutaneous anaphylaxis test after once weekly sensitization during 30 days. Conjunctival test revealed no hypersensitivity to medical device in guinea pigs after three times sensitization for every 48 hours. Guinea pig maximization test did not reveal any skin-sensitizing effect of the medical device. Bone marrow chromosome aberration test did not detect genotoxic effects of the medical device.

Keywords

• collagen gel
• allergenic effects
• genotoxic effects
• chromosome aberration test
• laboratory animals