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Characterisation and toxicological behaviour of Basic Methacrylate Copolymer for GRAS evaluation.
Johanna Eisele1, Geoff Haynes, Tiana Rosamilia
1Evonik Röhm GmbH, Kirschenallee, 64293 Darmstadt, Federal Republic of Germany.
Regulatory Toxicology and Pharmacology : RTP
|June 28, 2011
Summary
Basic Methacrylate Copolymer is safe for use as a pharmaceutical excipient and food additive. Studies show minimal absorption and no toxicity, supporting an adequate Acceptable Daily Intake (ADI) for adults and children.
Area of Science:
- Polymer Chemistry
- Toxicology
- Food Science
Background:
- Basic Methacrylate Copolymer is a cationic polymer used as a pharmaceutical excipient.
- It possesses taste-masking and moisture protection properties.
- Potential application as a glazing/coating agent for food supplements.
Purpose of the Study:
- To evaluate the safety profile of Basic Methacrylate Copolymer.
- To determine its toxicological impact and establish an Acceptable Daily Intake (ADI).
Main Methods:
- Oral administration of radiolabelled copolymer to rats.
- Sub-chronic toxicity study in rats (up to 2000 mg/kg/day).
- Sub-acute toxicity study in dogs (up to 750 mg/kg/day).
- Reproductive toxicity study in rats (up to 1000 mg/kg/day).
- Genotoxicity, acute toxicity, irritation, and sensitization tests.
Main Results:
- Major excretion route via feces; minimal absorption (<0.02%).
- No adverse toxicity observed in sub-chronic (rat) and sub-acute (dog) studies.
- No reproductive toxicity or genotoxicity detected.
- Low acute toxicity, no irritation or sensitization potential.
Conclusions:
- Basic Methacrylate Copolymer exhibits a favorable safety profile.
- An Acceptable Daily Intake (ADI) of 20 mg/kg body weight (bw) is established.
- Estimated daily exposure levels are well within the ADI, deeming it adequate.
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