关键词： BCA CAS Chemical Abstract Service Coating agent DMEM DMF DMSO DNFCS Dulbecco’s Modified Eagle’s Medium Dutch National Food Consumption Survey EA EC EFSA EUDRAGIT® NE EUDRAGIT® NM European Council European Food Safety Authority European Pharmacopoeia Food additive GLP GPC GRAS Good Laboratory Practice ICH INCI IUPAC International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use International Nomenclature for Cosmetic Ingredients International Union of Pure and Applied Chemistry JPE Japanese Pharmaceutical Excipients LD50 MMA MNPCE MOS Mn Mw NMT NOAEL Neutral Methacrylate Copolymer OECD Organisation for Economic Co-operation and Development PCE Ph. Eur. Polymer toxicity RIVM Rijksinstituut voor Volksgezondheid en Milieu SCF SEM Safety Scientific Committee on Food TDI TK UK US USA USP/NF United Kingdom United States United States Pharmacopoeia/National Formulary United States of America average molecular weight by number average molecular weight by weight bicinchoninic acid body weight bw dimethyl sulphoxide drug master file ethyl acrylate gel permeation chromatography generally recognised as safe margin of safety median lethal dose methyl methacrylate micronucleated polychromatic erythrocytes no observed adverse effect level not more than polychromatic erythrocytes scanning electron microscope thymidine kinase locus total daily intake

Mesh ： Animals Consumer Product Safety Drug Evaluation, Preclinical Excipients / chemistry toxicity Food Additives / chemistry pharmacokinetics toxicity Methacrylates / chemistry pharmacokinetics toxicity Microscopy, Electron, Scanning No-Observed-Adverse-Effect Level Rabbits Rats Surface Properties Toxicity Tests / methods

来  源：   DOI：10.1016/j.yrtph.2013.08.019   PDF(Sci-hub)

Abstract：
Neutral Methacrylate Copolymer is a fully polymerised copolymer used in the pharmaceutical industry to permit pH-independent delayed release of active ingredients from oral dosage forms. This function has potential use with food supplements and this article describes available information on the safety of the substance. Oral administration of radiolabelled copolymer to rats resulted in the detection of chemically unchanged copolymer in the faeces, with negligible absorption. Safety studies revealed no adverse toxicity following repeated administration at doses of up to 2000 mg/kg bw/d in a sub-chronic study in rats or 250 mg/kg bw/d in a sub-chronic study in dogs. No reproductive toxicity occurred at up to 2000 mg/kg bw/d in rats or rabbits. The substance shows no evidence of genotoxicity, has low acute toxicity and no irritation or sensitisation potential. An ADI value of 20 mg/kg bw was concluded from two alternative approaches. Daily exposure from use in dietary supplements is estimated as up to 10.0 mg/kg bw in adults and 13.3 mg/kg bw in children. There would therefore appear to be no safety concerns under the intended conditions of use. The information provided is intended to support an evaluation that the substance may be \"generally recognized as safe\" (GRAS).
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