Preclinical studies on toxicity, sensitizing effects, mutagenicity, compatibility with biological tissues have been conducted in 2003 and 2008 in the following accredited institutions:
- The test chemical analytical laboratory, FSUE Research Institute of rubber and latex products RAS.
- Laboratory of Medical Biotechnology, Research Institute of Biomedical Chemistry of the Orekhovich, RAMS.
- Laboratory of Clinical Microbiology and control of nosocomial infections, SEI of Moscow Medical Academy named after Sechenov.
- Laboratory of Experimental Pathomorphology, SEI of Moscow Medical Academy named after Sechenov.
- Laboratory of toxicological testing and research of materials and medical products, the VCO All-Russian Research and Testing Institute for Medical Devices Health Ministry.
- Research Laboratory Center, Research Institute of Physico-Chemical Medicine.
|The research method (institution conducts research)||Regulatory document||Brief Description of tests||Results|
|Chemical stability (1)||GOST R ISO 10993.12-99 (EN 30993-12-1994)||PH determination, dry solids content, refractive index||The values of these parameters are within the acceptable levels, the material is chemically stable|
|Determination of the content of monomer (acrylamide) (1)||GOST R ISO 10993.9-99 (EN 30993-9-1994), GOST R ISO 10993.12-99, GOST R ISO 10993.13-99||Acrylamide was determined in the chromatographic conditions||Monomer content does not exceed allowable values|
|Determination of the content of metals (1)||GOST R ISO 10993.15-99 (EN 30993-15-1994)||Metal content was performed by laser spectrometry device "Emal-2"||The amount of metal found do not exceed permissible levels|
|Study of cytotoxic effect (2)||GOST R ISO 10993.5-99 (EN 30993-5-1994)||The cytotoxicity was studied on the pheochromocytoma cell line of PC12 rats using MTT assay||Not cytotoxic|
|Study of acute toxicity (5)||GOST R ISO 10993.11-99 (EN 30993-11-1994), Annex B, B1||The acute toxicity was studied on white mice by intraperitoneal injection material||At a dose of 50 ml/kg of body weight of animal deaths not marked of mice and clinical signs of intoxication|
|Study of sub-chronic toxicity (4)||GOST R ISO 10993.11-99 (EN 30993-11 1994)||Sub-chronic toxicity was studied on white rats by subcutaneous injection||During 2.5 months systemic toxicity of the material not revealed|
|Study of chronic toxicity (4)||GOST R ISO 10993.11-99 (EN 30993-11-1994)||Chronic toxicity was studied on dogs after subcutaneous injection||During the 18 months toxic effects not revealed|
|Study of hemolytic action (5)||GOST R ISO 10993.4-1999 (EN 30993-4-1994), Annex B||Studied the hemolytic effect of extracts of of the material "in vitro" in isolated erythrocytes of rabbits||Extracts of all samples tested showed no hemolytic activity|
|Study of sensitizing effect (5)||GOST R ISO 10993.10-99 (EN 30993-10-1994), Appendix E||In the experiment on white rats were used immunological response of mast cell degranulation||Sensitizing effect of the material is not revealed|
|Mutagenic effects (5)||GOST R ISO 10993.3-99 (EN 30993-3-1994)||Research using micronucleus test of bone marrow preparations on white mice hip||Mutagenic activity of the material is not shown|
|GOST R ISO 10993.3-99 (EN 30993-10-1994)||Gonadotropic effect was evaluated as histological structure of the reproductive organs of male ratsв||Deviations from the norm gonadal structure is not revealed|
|Pathological examination of the internal organs (4)
|GOST R ISO 10993.3-99 (EN 30993-3-1994)||Morphological study of the bodies was carried out in sub-chronic experiment on white rats and chronic experiments on dogs||There were no changes in internal organs histostructure|
|Implantation test (4)
|GOST R ISO 10993.6-99 (EN 30993-6-1994)||A histological study of the area of implantation in rats, rabbits and dogs||There was a weakly expressed tissue reaction and a high degree of biocompatibility|
|Test of biological safety (6)||GOST R ISO 10993 GOST 51148-98 GN 2.3.3972-00 MU 1.1.037-95||In connection with the change in the method of giving the product antiseptic properties conducted additional comprehensive study of samples of sanitary-chemical tests for acute toxicity tests, hemolytic activity "in vitro", local irritant effect, sterility and sample apirogennost in toxicological tests||Material chemically stable, extract do not have adverse effects on biological objects|