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Pre-clinical studies

Preclinical studies on toxicity, sensitizing effects, mutagenicity, compatibility with biological tissues have been conducted in 2003 and 2008 in the following accredited institutions:

Содержание доклинических исследований НОЛТРЕКС™
The content of pre-clinical studies NOLTREX™
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
Gonadotoxicity (4)
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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)
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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)
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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





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