THE STUDY OF ALLERGENIC AND GENOTOXIC EFFECTS OF THE MEDICAL DEVICE «RESORBABLE COLLAGEN MATERIAL COLLOST®, GEL» IN THE PRE-CLINICAL MODELS IN VIVO
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.
About the Authors
I. A. Demyanenko
N.F. Gamaleya Federal Research Center for Epidemiology & Microbiology
Russian Federation
Russian Federation
N. V. Kalmykova
N.F. Gamaleya Federal Research Center for Epidemiology & Microbiology
Russian Federation
Russian Federation
S. V. Melnikova
Russia Research Center for Toxicology and Hygienic Regulation of Biopreparations - branch of FSBU "State Research Center Institute of Immunology of Federal Medical and Biological Agency
Russian Federation
Russian Federation
A. V. Tretyakova
Russia Research Center for Toxicology and Hygienic Regulation of Biopreparations - branch of FSBU "State Research Center Institute of Immunology of Federal Medical and Biological Agency
Russian Federation
Russian Federation
A. I. Marchenko
Russia Research Center for Toxicology and Hygienic Regulation of Biopreparations - branch of FSBU "State Research Center Institute of Immunology of Federal Medical and Biological Agency
Russian Federation
Russian Federation
L. V. Mikhina
Russia Research Center for Toxicology and Hygienic Regulation of Biopreparations - branch of FSBU "State Research Center Institute of Immunology of Federal Medical and Biological Agency
Russian Federation
Russian Federation
A. P. Suslov
N.F. Gamaleya Federal Research Center for Epidemiology & Microbiology
Russian Federation
Russian Federation
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Review
For citations:
Demyanenko I.A., Kalmykova N.V., Melnikova S.V., Tretyakova A.V., Marchenko A.I., Mikhina L.V., Suslov A.P. THE STUDY OF ALLERGENIC AND GENOTOXIC EFFECTS OF THE MEDICAL DEVICE «RESORBABLE COLLAGEN MATERIAL COLLOST®, GEL» IN THE PRE-CLINICAL MODELS IN VIVO. Drug development & registration. 2017;(4):256-261. (In Russ.)
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