Animal carcinogenicity studies: Implications for the REACH system

Alternatives to Laboratory Animals

Volumn 34, Issue SUPPL. 1, 2006, Pages 139-147

  Knight, Andrew ^a   Bailey, Jarrod ^b   Balcombe, Jonathan ^c  

^a Animal Consultants International   (United Kingdom)

^b NEWCASTLE UNIVERSITY   (United Kingdom)

^c PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE   (United States)

Author keywords

Alternative; Animal experiment; Animal test; Bioassay; Cancer prevention; Carcinogenicity; Chemical classification; Chemical safety; Computer simulation; REACH; Risk assessment

Indexed keywords

CARCINOGEN; CHEMICAL AGENT;

ANIMAL TESTING ALTERNATIVE; ANIMAL TESTING REDUCTION; ANIMAL TESTING REFINEMENT; ANIMAL TESTING REPLACEMENT; BIOASSAY; CANCER PREVENTION; CANCER RISK; CARCINOGENICITY; CHEMICAL INDUSTRY; CLASSIFICATION; COMPUTER SIMULATION; COST CONTROL; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL HEALTH; ENVIRONMENTAL PROTECTION; EUROPEAN UNION; EVALUATION; EVIDENCE BASED MEDICINE; HEALTH HAZARD; HUMAN; NONHUMAN; POLICY; PREDICTION; PRIORITY JOURNAL; PUBLIC HEALTH; REGISTRATION; REVIEW; RISK ASSESSMENT; RODENT; SAFETY; TOXICITY TESTING;

ANIMALIA; RODENTIA;

EID: 33645561835     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (18)

1. Postle, M., Vernon, J., Zarogiannis, P. & Salado, R. (2003). Assessment of the Impact of the New Chemicals Policy on Occupational Health: Final Report: prepared for European Commission - Environment Directorate-General. 96pp. Loddon, Norfolk, UK: Risk & Policy Analysts Limited.
2. Agresti, A. & Coull, B.A. (1998). Approximate is better than "exact" for interval estimation of binomial proportions. The American Statistician 52, 119-126. The modified Wald method is also described at http://www.graphpad.com/quickcalcs/ConfInterval2. cfm.
3. Knight, A., Bailey, J. & Balcombe, J. (2006). Animal carcinogenicity studies: 1. Poor human predictivity. ATLA 34, 19-27.
4. Knight, A., Bailey, J. & Balcombe, J. (2006). Animal carcinogenicity studies: 2. Obstacles to extrapolation of data to humans. ATLA 34, 29-38.
5. National Toxicology Program (2002). National Toxicology Program Report on Carcinogens, 10th Edition. Website http://ntp.niehs.nih.gov/ntpweb/index.cfm? objectid = 72016262-BDB7-CEBA-FA60E922B18C2540 (Accessed 13.01.05).
6. Tomatis, L. & Wilbourn, J. (1993). Evaluation of carcinogenic risk to humans: the experience of IARC. In New Frontiers in Cancer Causation (ed. O.H. Iversen), pp. 371-387. Washington, DC, USA: Taylor and Francis.
7. International Agency for Research on Cancer, (undated). IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans. Website http://monographs.iarc.fr (Accessed 01.01.04).
8. Monro, A.M. & MacDonald, J.S. (1998). Evaluation of the carcinogenic potential of pharmaceuticals. Opportunities arising from the International Conference on Harmonisation. Drug Safety 18, 309-319.
9. Ashby, J. (1996). Alternatives to the 2-species bioassay for the identification of potential human carcinogens. Human and Experimental Toxicology 15, 183-202.
10. Gold, L.S., Manley, N.B., Slone, T.H. & Rohrbach, L. (1999). Supplement to the Carcinogenic Potency Database (CPDB): Results of animal bioassays published in the general literature in 1993 to 1994 and by the National Toxicology Program in 1995 to 1996. Environmental Health Perspectives 107, Suppl. 4, 527-600.
11. Hogan, K.A. (2000). Characterization of Data Variability and Uncertainty: Health Effects Assessments in the Integrated Risk Information System (IRIS). EPAI635/R-00/005A. 27pp. National Center for Environmental Assessment, Washington, DC, USA: Environmental Protection Agency, Office of Research and Development, Environmental Protection Agency.
12. Haseman, K. (2000). Using the NTP database to assess the value of rodent carcinogenicity studies for determining human cancer risk. Drug Metabolism Reviews 32, 169-186.
13. Gold, L.S., Slone, T.H. & Ames, B.N. (1998). What do animal cancer tests tell us about human cancer risk? Overview of analyses of the carcinogenic potency database. Drug Metabolism Reviews 30, 359-404.
14. Rall, D.P. (2000). Laboratory animal tests and human cancer. Drug Metabolism Reviews 32, 119-128.
15. Ashby, J. & Purchase, I.F. (1993). Will all chemicals be carcinogenic to rodents when adequately evaluated? Carcinogenesis 8, 489-495.
16. Fung, V., Barrett, J. & Huff, J. (1995). The carcinogenesis bioassay in perspective: Application in identifying human hazards. Environmental Health Perspectives 103, 680-683.
17. Ennever, F.K. & Lave, L.B. (2003). Implications of the lack of accuracy of the lifetime rodent bioassay for predicting human carcinogenicity. Regulatory Toxicology and Pharmacology 38, 52-57.
18. Knight, A., Bailey, J. & Balcombe, J. (2006). Animal carcinogenicity studies: 3. Alternatives to the bioassay. ATLA 34, 39-48.