ToxSci Advance Access originally published online on June 8, 2004
Toxicological Sciences 2004 82(1):3-8; doi:10.1093/toxsci/kfh189
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Toxicological Sciences vol. 82 no. 1 © Society of Toxicology 2004; all rights reserved.
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Human Carcinogenic Risk Evaluation, Part IV: Assessment of Human Risk of Cancer from Chemical Exposure Using a Global Weight-of-Evidence Approach
Schering-Plough Research Institute, Kenilworth, New Jersey, 07033
Received April 13, 2004; accepted May 27, 2004
Key Words: Comet assay; quantile dispersion graphs; tail moment; Olive tail moment; extent tail moment; tail DNA; tail length; lymphocytes; DNA damage.
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In the early 1960s, the National Cancer Institute developed procedures to formalize the process for the evaluation of the human risk of cancer from chemical exposure (Boorman, 1994
; Weisburger, 1983). This approach was based on decades of research that demonstrated that chemicals that were known to cause cancer in humans could be shown to induce cancer in laboratory animals as well. Despite the fact that this approach by the NCI was envisioned as an initial assessment of carcinogenic activity to identify those chemicals for which further study was needed, the use of two rodent species exposed for 2 years as the primary mechanism to identify potential human hazards was in widespread use by the early 1970s (Boorman, 1994). In 1975, this process was developed into a recommendation that has formed the basis of regulatory guidance (Sontag, 1976). This guidance represented the best thinking of the time
* To whom correspondence should be addressed: Schering-Plough Research Institute, 2015 Galloping Hill Rd., Kenilworth, NJ 07033. Fax: (973) 940-4159. E-mail: james.madonald@spcorp.com.
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