Safety evaluation and risk assessment using immunotoxicology methods.
Dean JH; Hincks J; Luster MI; Gerberick GF; Neumann DA; Hastings KL
Int J Toxicol 1998 May-Jun; 17(3):277-296
The field of immunotoxicity has advanced considerably in the past few years with the systematic evaluation of methods to predict immunosuppression, myelosuppression, and certain types of hypersensitivity. International interlaboratory comparisons have been conducted with methods for detecting immunosuppression (White et al., 1994) and contact hypersensitivity with good agreement (Kimber et al., 1995). The standard tier for immunotoxicity assessment, as described by the National Toxicology Program (Luster et al., 1988), and methods suggested by the GECD 407 Guideline (van Loveren et al., 1996) are considered useful in both the mouse and rat. Likewise, these new methods have been introduced and evaluated in the safety assessment of new pharmaceuticals and chemicals by some companies. Most of the methods developed have been drawn from our experience in clinical immunology and an improved understanding of the immune system through advances in molecular biology and basic immunology. There is still work to be done to better document the correlation between animal immunotoxicity results and adverse effects in humans following exposure to chemicals in our environment, and to define predictive methods for evaluating the potential of a drug to induce allergy and autoimmunity, still a significant unpredicted clinical finding.
Risk-factors; Safety-measures; Safety-practices; Safety-research; Immune-reaction; Immunodiagnosis; Immunology; Toxic-effects; Toxicology
JH Dean, Sanofi Res, Sanofi Pharmaceut Inc, 9 Great Valley Pkwy,POB 3026, Malvern, PA 1935
International Journal of Toxicology