European Chemicals Agency accepts results of Russian GLP-laboratory nonclinical study

August 13, 2019

The European Chemicals Agency (ECHA) has accepted the results of the study done by the Laboratory of Biological Research of the Russian Academy of Sciences Bioorganic Chemistry Institute Branch.

The marketing authorization file for the substance 4-(octadecylamino)-4-oxoisocrotonic acid (EC number: 221-361-2, CAS number: 3077-27-8) produced by the company SYNTHOPOL CHEMIE (Germany) which specializes in the development and production of synthetic resins for the paint and varnish industry and plastic is presented on the website of ECHA. The Reproductive Toxicity section of this file includes a report with the data of the research conducted in the Laboratory of Biological Research of the Russian Academy of Sciences Bioorganic Chemistry Institute Branch. Laboratory animals used in this study came from the “Pushino” incubator of the Russian Academy of Sciences Bioorganic Chemistry Institute Branch.

The Laboratory of Biological Research of the Russian Academy of Sciences Bioorganic Chemistry Institute Branch is the first laboratory to receive the official international recognition of compliance with SNAS GLP principles in 2013. The area of activity of the mentioned laboratory includes all products subject to testing with the use of GLP principles (medications, pesticides, cosmetics, veterinary drugs, food and feed supplements, chemicals for industrial purposes). The range of studies of a GLP-laboratory accounts for 30% of the total number of research methods applied in nonclinical (preclinical) laboratory studies in OECD. International recognition of compliance with GLP principles allows a laboratory to export advanced services – nonclinical (preclinical) studies for foreign customers.