Characterisation and toxicological assessment of Neutral Methacrylate Copolymer for GRAS evaluation

Regulatory Toxicology and Pharmacology

Volumn 67, Issue 3, 2013, Pages 392-408

  Eisele, Johanna ^a   Haynes, Geoff ^b   Kreuzer, Knut ^a   Rosamilia, Tiana ^c  

^a EVONIK INDUSTRIES AG   (Germany)

^b Haynes Safety Services Ltd   (United Kingdom)

^c Evonik Degussa Corporation   (United States)

Author keywords

Coating agent; EUDRAGIT NE; EUDRAGIT NM; Food additive; GRAS; Neutral Methacrylate Copolymer; NOAEL; Polymer toxicity; Safety

Indexed keywords

COPOLYMER; FOOD ADDITIVE; MACROGOL; METHACRYLIC ACID; METHACRYLIC ACID COPOLYMER; POLY(ETHYL ACRYLATE CO METHYLMETHACRYLATE); UNCLASSIFIED DRUG;

ABSORPTION; ALLERGIC REACTION; ARTICLE; CYTOTOXICITY; DEVELOPMENTAL TOXICITY; DRUG COATING; DRUG SAFETY; FOOD SAFETY; GENE MUTATION; GENOTOXICITY; HISTOPATHOLOGY; IN VITRO STUDY; MOLECULAR WEIGHT; MOUTH TOXICITY; NONHUMAN; PARTICLE SIZE; PH; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; RADIOACTIVITY; REPRODUCTIVE TOXICITY; SKIN IRRITATION; SKIN SENSITIZATION; TEMPERATURE; TERATOGENICITY; TISSUE DISTRIBUTION; TOXICITY; TOXICITY TESTING; TOXICOKINETICS; VISCOSITY;

CANIS FAMILIARIS; ORYCTOLAGUS CUNICULUS; RATTUS;

AVERAGE MOLECULAR WEIGHT BY NUMBER; AVERAGE MOLECULAR WEIGHT BY WEIGHT; BCA; BICINCHONINIC ACID; BODY WEIGHT; BW; CAS; CHEMICAL ABSTRACT SERVICE; COATING AGENT; DIMETHYL SULPHOXIDE; DMEM; DMF; DMSO; DNFCS; DRUG MASTER FILE; DULBECCO'S MODIFIED EAGLE'S MEDIUM; DUTCH NATIONAL FOOD CONSUMPTION SURVEY; EA; EC; EFSA; ETHYL ACRYLATE; EUDRAGIT® NE; EUDRAGIT® NM; EUROPEAN COUNCIL; EUROPEAN FOOD SAFETY AUTHORITY; EUROPEAN PHARMACOPOEIA; FOOD ADDITIVE; GEL PERMEATION CHROMATOGRAPHY; GENERALLY RECOGNISED AS SAFE; GLP; GOOD LABORATORY PRACTICE; GPC; GRAS; ICH; INCI; 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; IUPAC; JAPANESE PHARMACEUTICAL EXCIPIENTS; JPE; LD50; MARGIN OF SAFETY; MEDIAN LETHAL DOSE; METHYL METHACRYLATE; MICRONUCLEATED POLYCHROMATIC ERYTHROCYTES; MMA; MN; MNPCE; MOS; MW; NEUTRAL METHACRYLATE COPOLYMER; NMT; NO OBSERVED ADVERSE EFFECT LEVEL; NOAEL; NOT MORE THAN; OECD; ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT; PCE; PH. EUR.; POLYCHROMATIC ERYTHROCYTES; POLYMER TOXICITY; RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU; RIVM; SAFETY; SCANNING ELECTRON MICROSCOPE; SCF; SCIENTIFIC COMMITTEE ON FOOD; SEM; TDI; THYMIDINE KINASE LOCUS; TK; TOTAL DAILY INTAKE; UK; UNITED KINGDOM; UNITED STATES; UNITED STATES OF AMERICA; UNITED STATES PHARMACOPOEIA/NATIONAL FORMULARY; US; USA; USP/NF;

ANIMALS; CONSUMER PRODUCT SAFETY; DRUG EVALUATION, PRECLINICAL; EXCIPIENTS; FOOD ADDITIVES; METHACRYLATES; MICROSCOPY, ELECTRON, SCANNING; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RABBITS; RATS; SURFACE PROPERTIES; TOXICITY TESTS;

EID: 84887820586     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.08.019     Document Type: Article

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