Characterisation and toxicological behaviour of Basic Methacrylate Copolymer for GRAS evaluation

Regul Toxicol Pharmacol. 2011 Oct;61(1):32-43. doi: 10.1016/j.yrtph.2011.05.012. Epub 2011 Jun 17.

Abstract

Basic Methacrylate Copolymer is a fully polymerised cationic copolymer with taste-masking and moisture protection properties. It is used as a pharmaceutical excipient and has potential use as a glazing/coating agent to solid food supplements. This article describes available information on the safety of the substance. Oral administration of radiolabelled copolymer to rats showed the major route of excretion to be via the faeces. Minor absorption may occur at <0.02%. Safety studies revealed no adverse toxicity following repeated administration at up to 2000 mg/kg/day in a sub-chronic study in the rat or 750 mg/kg/day in a sub-acute study in the dog. No reproductive toxicity occurred at up to 1000 mg/kg/day in the rat. The substance shows no evidence of genotoxicity, has low acute toxicity and no irritation or sensitisation potential. As per the FDA approach an ADI of 20 mg/kg bw can be concluded. Daily exposure from use as a food additive is estimated as up to 11.7 mg/kg bw in adults and 13.3 mg/kg bw in children. In view of the high molecular weight of the substance, its lack of absorption and its low toxicity profile, the ADI is deemed adequate.

MeSH terms

  • Administration, Oral
  • Administration, Topical
  • Animals
  • Dermatitis, Phototoxic / metabolism
  • Dogs
  • Excipients / administration & dosage
  • Excipients / chemical synthesis
  • Excipients / pharmacokinetics
  • Excipients / toxicity*
  • Female
  • Food Additives / administration & dosage
  • Food Additives / chemical synthesis
  • Food Additives / pharmacokinetics
  • Food Additives / toxicity*
  • Food Safety*
  • Hypodermoclysis
  • Infusions, Parenteral
  • Male
  • Methylmethacrylates / administration & dosage
  • Methylmethacrylates / chemical synthesis
  • Methylmethacrylates / pharmacokinetics
  • Methylmethacrylates / toxicity*
  • Mice
  • No-Observed-Adverse-Effect Level
  • Rats
  • Rats, Sprague-Dawley
  • Risk Assessment / methods*
  • Time Factors
  • Toxicity Tests*
  • United States
  • United States Food and Drug Administration

Substances

  • Excipients
  • Food Additives
  • Methylmethacrylates
  • Eudragit-E