Systemic toxicity testing

Auletta, C. (1998). Acute systemic toxicity testing. In Handbook of Product Safety Assessment, 2nd ed. (Gad, S., Ed.). Marcel Dekker, New York. 

Methods and measurements used in biomonitoring for ecological effects. A number of methods are used both in a laboratory situation and in the field to attempt to classify the effects of xeno-biotics upon ecological systems. Toxicity tests can be used to examine effects at several levels of biological organization and can be performed with species introduced as monitors for a particular environment. 

The tests to be performed to assess both efficacy and toxicity of drugs are highly regulated in the EU, as in most countries in the world. The EU rules and regulations governing medicinal products are compiled in a ten-volume legislation called Eudralex available from the website of the EC (http //ec.europa.eu/health/ documents/eudralex/index en.htm). Specific requirements on acute and chronic systemic toxicity testing of pharmaceuticals are addressed later in this chapter. 

Hengstler JG, Marchan R, Leist M (2012) Highlight report towards the replacement of in vivo repeated dose systemic toxicity testing. Arch Toxicol 86(1) 13-15. doi 10.1007/ s00204-011-0798-7... 

Basketter DA, Clewell H, Kimber I, Rossi A, Blaauboer B, Burner Ret al (2012) A roadmap for the development of alternative (nonanimal) methods for systemic toxicity testing— t4 report. ALTEX 29 3-91... 

Gennari A, van den Berghe C, Casati S, Castell J, Clemedson C, Coecke S et al (2004) Strategies to replace in vivo acute systemic toxicity testing. The report and recommendations of ECVAM Workshop 50. Altern Lab Anim 32 437 59... 

Bouhifd M, Bories G, Casado J, Coecke S, Norlen H, Parissis N, Rodrigues RM, Whelan MP (2012) Automation of an in vitro cytotoxicity assay used to estimate starting doses in acute oral systemic toxicity tests. Food Chem Toxicol 50 2084-2096... 

Systemic toxicity tests estimate the potential harmful effects of either single or multiple exposures, during a period of less than 24 h, to medical devices, biomaterials, and/or their extracts. These tests evaluate the systemic toxicity potential of medical devices that release constituents into the body. These tests also include pyrogenicity testing. 

There are several standards that medical polymers must adhere to. One of the most common standards observed for polymeric materials is published by the United States Pharmacopeia (USP), which necessitates using animal models (in vivo) to test toxicity of elastomers, plastics, and other polymeric materials, prior to clinical use. The standard and forms of testing it outlines is considered in the medical industry as the minimum requirement for a polymeric material before it is considered for use in healthcare applications. According to the standard the biological response of the test animals are measured and determined via three main techniques (1) Systemic toxicity test Evaluates the effects of leachables of intravenously or intraperitoneally injected materials on systems such as the nervous or immune system (2) Intracutaneous test Evaluates local response to materials injected under the skin (3) Implantation test Both local tissue microscopic and macroscopic parameters evaluated at material implant sites. 

Systemic toxicity testing, such as the ISO acute systemic toxicity test, pyrogenicity test, USP/ Code of Eederal Regulations (CER) pyrogen test, ISO rabbit pyrogen test, USP systemic injection test, USP intracutaneous test, USP implant test, and USP safety test. 

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