Safety Assessment of Cry1C Protein From Genetically Modified Rice According to the National Standards of PR China for a New Food Resource

Regul Toxicol Pharmacol. 2010 Dec;58(3):474-81. doi: 10.1016/j.yrtph.2010.08.018. Epub 2010 Aug 27.

Abstract

The Cry1C protein produced in Escherichia coli was used for in vitro evaluation and animal studies to support the safety assessment of GM food or feed products containing the Cry1C protein. The Cry1C protein does not have any sequence homology with known allergens or toxins. Although the Cry1C protein was heat stable it was rapidly degraded in vitro with simulated gastric or intestinal fluids. It did not cause adverse effects in mice as administered by gavage at a high level dosage of 5 g (Cry1C protein)/kg body weight. The mutagenicity of this protein was evaluated according to the national standards of People's Republic of China (PR China) for a new food resource. In mutagenic tests, the Cry1C protein caused<4 micronucleated cells per 1000 cells, <16 sperm abnormalities per 1000 cells and was not associated with any increased mutations in the Ames test. Taken together, these data indicate that the Cry1C protein is not a potential allergen or toxin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Allergens
  • Amino Acid Sequence
  • Animals
  • Bacterial Proteins / chemistry
  • Bacterial Proteins / genetics
  • Bacterial Proteins / metabolism
  • Bacterial Proteins / toxicity*
  • Blood Chemical Analysis
  • China
  • Consumer Product Safety
  • Endotoxins / chemistry
  • Endotoxins / genetics
  • Endotoxins / metabolism
  • Endotoxins / toxicity*
  • Escherichia coli / genetics
  • Escherichia coli / metabolism
  • Female
  • Food, Genetically Modified / toxicity*
  • Hematologic Tests
  • Hemolysin Proteins / chemistry
  • Hemolysin Proteins / genetics
  • Hemolysin Proteins / metabolism
  • Hemolysin Proteins / toxicity*
  • Hot Temperature
  • Male
  • Mice
  • Mice, Inbred ICR
  • Oryza / genetics*
  • Plants, Genetically Modified / toxicity*
  • Protein Stability
  • Risk Assessment

Substances

  • Allergens
  • Bacterial Proteins
  • Endotoxins
  • Hemolysin Proteins
  • insecticidal crystal protein, Bacillus Thuringiensis