Selected Document Category:Published Document
Source:International Organization for Standardization
Anticipated Publication Year:
Publication Year:2010
Document Title:Nanotechnologies — Endotoxin test on nanomaterial samples for in vitro systems — Limulus amebocyte lysate (LAL) test

This International Standard describes the application of a test using Limulus amebocyte lysate (LAL) reagent for the evaluation of nanomaterials intended for cell-based in vitro biological test systems. The test is suitable for use with nanomaterial samples dispersed in aqueous media, e.g. water, serum or reaction medium, and to such media incubated with nanomaterials for an appropriate duration at 37 °C.
This International Standard is restricted to test samples for in vitro systems, but the methods can also be adapted to nanomaterials to be administered to animals by parenteral routes.

Type of Document:a. Standard
Issues Areas:Health, Safety, and Environment
Primary Category:General Industry/Manufacturing
Additional CategoriesChemicals e.g. pesticides, pharmaceuticals, paints, basic chemicals;
Goal or Need:Endotoxins can cause a variety of systemic reactions in mammals, including humans, such as fever, disseminated intravascular coagulation, hypotension, shock and death: the responses are mediated by production of various kinds of cytokines, activation of the complement cascade, activation of the coagulation cascade, etc. Endotoxins are present in the ordinary environment. Since most test samples of nanomaterials intended for in vitro and in vivo test systems require various preparation procedures, endotoxins might contaminate the test nanomaterials if the samples are prepared without special care.
Intended Stakeholders:
Is it Being Implemented:
Submitter's Name:Heather Benko
Submitter's e-mail:hbenko@ansi.org
Submitter's Company:ANSI
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