ze, evaluate, and interpret data contained in the NTP rodent carcinogenicity database and other large databases. As the NTP carcinogenicity database becomes increasingly accessible to the general scientific community, there is increased opportunity for inadvertent misuse of the database by those who may not have a complete understanding of the complex information it contains. We demonstrated that a previously published evaluation of the NTP database exaggerated the frequencies of statistically significant decreasing tumor trends, The factors contributing to these errors included failure to adjust for survival differences, evaluating improper tumor combinations, failure to achieve the reported (p<0.01) level of significance, double counting a chemical's site-specific decreased tumor incidence, and using scientifically inadequate studies. In another project, we evaluated the large database of results from the Frog Embryo Teratogenesis Assay - Xenopus (FETAX), as part of an ICCVAM (Interagency Coordinating Committee on the Validation of Alternative Methods) initiative, We found that in some cases there was significant inter-laboratory variability in the reported malformation rates that appeared to be related to diagnostic differences among investigators, Based on these results, specific recommendations were made as to how the FETAX protocols could be improved to reduce this variability and facilitate any future validation of this assay.

Agency
National Institute of Health (NIH)
Institute
National Institute of Environmental Health Sciences (NIEHS)
Type
Intramural Research (Z01)
Project #
1Z01ES045004-04
Application #
6432303
Study Section
(BB)
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
2000
Total Cost
Indirect Cost
Name
U.S. National Inst of Environ Hlth Scis
Department
Type
DUNS #
City
State
Country
United States
Zip Code
Kissling, Grace E; Haseman, Joseph K; Zeiger, Errol (2015) Proper interpretation of chronic toxicity studies and their statistics: A critique of ""Which level of evidence does the US National Toxicology Program provide? Statistical considerations using the Technical Report 578 on Ginkgo biloba as an example"". Toxicol Lett 237:161-4
Mercado-Feliciano, Minerva; Cora, Michelle C; Witt, Kristine L et al. (2012) An ethanolic extract of black cohosh causes hematological changes but not estrogenic effects in female rodents. Toxicol Appl Pharmacol 263:138-47
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Singh, B P; Nyska, A; Kissling, G E et al. (2010) Urethral carcinoma and hyperplasia in male and female B6C3F1 mice treated with 3,3',4,4'-tetrachloroazobenzene (TCAB). Toxicol Pathol 38:372-81
Auerbach, Scott S; Shah, Ruchir R; Mav, Deepak et al. (2010) Predicting the hepatocarcinogenic potential of alkenylbenzene flavoring agents using toxicogenomics and machine learning. Toxicol Appl Pharmacol 243:300-14
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Stout, Matthew D; Herbert, Ronald A; Kissling, Grace E et al. (2009) Hexavalent chromium is carcinogenic to F344/N rats and B6C3F1 mice after chronic oral exposure. Environ Health Perspect 117:716-22
Knudsen, G A; Cheng, Y; Kuester, R K et al. (2009) Effects of dose and route on the disposition and kinetics of 1-butyl-1-methylpyrrolidinium chloride in male F-344 rats. Drug Metab Dispos 37:2171-7
Cheng, Y; Wright, S H; Hooth, M J et al. (2009) Characterization of the disposition and toxicokinetics of N-butylpyridinium chloride in male F-344 rats and female B6C3F1 mice and its transport by organic cation transporter 2. Drug Metab Dispos 37:909-16

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