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.
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) File 1 File 2 |
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) File 1 File 2 |
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) File 1 File 2 File 3 |
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 |