Spontaneous Neoplasm Incidences in Fischer 344 Rats and B6C3F1 Mice in Two-Year Carcinogenicity Studies: A National Toxicology Program Update

Toxicologic Pathology

Volumn 26, Issue 3, 1998, Pages 428-441

  Haseman, Joseph K ^a   Hailey, James R ^b   Morris, Richard W ^b  

^a NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

^b Research Triangle Institute   (United States)

Author keywords

B6C3F; F344 rats; historical control data; mice; National Toxicology Program; Tumor incidence

Indexed keywords

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BREAST FIBROADENOMA; CANCER INCIDENCE; CARCINOGENICITY; CONTROLLED STUDY; DATA BASE; FEMALE; HISTOPATHOLOGY; HYPOPHYSIS TUMOR; LEUKEMIA; LIVER ADENOMA; LIVER CARCINOMA; LUNG ADENOMA; LUNG CARCINOMA; LYMPHOMA; MALE; MONONUCLEAR CELL; NONHUMAN; PHEOCHROMOCYTOMA; PRIORITY JOURNAL; RAT; TESTIS TUMOR;

ANIMALS; BODY WEIGHT; FEMALE; MALE; MICE; MICE, INBRED STRAINS; NEOPLASMS; RATS; RATS, INBRED F344; RODENT DISEASES; SURVIVAL RATE;

ANIMALIA; HELICOBACTER HEPATICUS; RODENTIA;

EID: 0031955224     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1177/019262339802600318     Document Type: Article

References (46)

1. Abdo KM and Kari FW (1996). The sensitivity of the NTP bioassay for carcinogen hazard evaluation can be modulated by dietary restriction. Exp. Toxicol. Pathol. 48: 129-137.
2. Allaben WT, Turturro A, Leakey JE, Seng JE, and Hart RW (1996). 1. FDA Points-to-Consider documents: The need for dietary control for the reduction of experimental variability within animal assays and the use of dietary restriction to achieve dietary control. Toxicol. Pathol. 24: 776-781.
3. Boorman GA and Eustis SL (1986). The Pathology Working Group as a means for assuring pathology quality in toxicological studies. In: Managing Conduct and Data Quality of Toxicology Studies, BK Hoover, JK Baldwin, AF Uelner, CE Whitmire, CL Davies, and DW Bristol (eds). Princeton Scientific, Princeton, New Jersey, pp. 271-275.
4. Boorman GA, Montgomery CA Jr, Eustis SL, Wolfe M, McConnell EE, and Hardisty JF (1985). Quality assurance in pathology for rodent carcinogenicity studies. In: Handbook of Carcinogen Testing, HA Milman and EK Weisberger (eds). Noyes, Park Ridge, New Jersey, pp. 345-357.
5. Chandra M and Frith CH (1992). Spontaneous neoplasms in B6C3F, mice. Toxicol. Lett. 60: 91-98.
6. Elwell MR, Dunnick JK, Hailey JR, and Haseman JK (1996). Chemicals associated with decreases in the incidence of mononuclear cell leukemia in the Fischer rat. Toxicol. Pathol. 24: 238-245.
7. Gart JJ, Chu KC, and Tarone RE (1979). Statistical issues in the interpretation of chronic bioassay tests for carcinogenicity. J. Natl. Cancer Inst. 62: 957-974.
8. Gart JJ, Krewski D, Lee PN, Tarone RE, and Wahrendorf J (1986). Statistical Methods in Cancer Research, Vol. 3, The Design and Analysis of Long-Term Animal Experiments. Scientific Publication No. 79, International Agency for Research on Cancer, Lyon, France.
9. Goodman DG, Ward JM, Squire RH, Chu KC, and Linhart MS (1979). Neoplastic and nonneoplastic lesions in aging F344 rats. Toxicol. Appl. Pharmacol. 48: 237-248.
10. Hardisty JF and Boorman GA (1986). National Toxicology Program pathology quality assurance procedures. In: Managing Conduct and Data Quality of Toxicology Studies, BK Hoover, JK Baldwin, AF Uener, CE Whitmire, CL Davies, and DW Bristol (eds). Princeton Scientific, Princeton, New Jersey, pp. 263-269.
11. Haseman JK (1992). Value of historical controls in the interpretation of rodent tumor data. Drug Inf. J. 26: 191-200.
12. Haseman JK (1995). Data analysis: Statistical analysis and use of historical control data. Regitl. Toxicol. Pharmacol. 21: 52-59.
13. Haseman JK (1995). Statistical considerations in long term dietary restriction studies. In: Dietary Restriction: Implications for the Design and Interpretation of Toxicity and Carcinogenicity Studies, RW Hart, DA Neumann, and RT Robertson (eds). International Life Sciences Institute, Washington, DC, pp. 141-153.
14. Haseman JK, Arnold J, and Eustis SL (1990). Tumor incidences in Fischer 344 rats: NTP historical data. In: Pathology of the F344 Rat, GA Boorman, SL Eustis, C Montgomery, and M Elwell (eds). Academic Press, San Diego, CA, pp. 555-564.
15. Haseman JK, Bourbina J, and Eustis SL (1994). The effect of individual housing and other experimental design factors on tumor incidence in B6C3F, mice. Fundam. Appl. Toxicol. 23: 44-52.
16. Haseman JK, Eustis SL, and Ward JM (1994). Contributing causes of death in rats and the utilization of this information in the statistical evaluation of tumor data. In: Pathology of Aging Animals, Vol. 1, U Mohr, C Capen, and D Dungworth (eds). ILSI Press, Washington, DC, pp. 629-638.
17. Haseman JK, Huff JE, and Boorman GA (1984). Use of historical control data in carcinogenicity students in rodents. Toxicol. Pathol. 12: 126-135.
18. Haseman JK, Huff JE, Rao GN, Arnold JE, Boorman GA, and McConnell EE (1985). Neoplasms observed in untreated and corn oil gavage control groups of F344/N rats and (C57BL/6N × C3HV HeN)F, (B6C3F,) mice. J. Natl. Cancer Inst. 75: 975-984.
19. Haseman JK, Huff JE, Rao GN, and Eustis SL (1989). Sources of variability in rodent carcinogenicity studies. Fundam. Appl. Toxi col. 12: 793-804.
20. Haseman JK and Rao GN (1992). Effects of corn oil, time-related changes and inter-laboratory variability on tumor occurrence in control Fischer 344 (F344/N) rats. Toxicol. Pathol. 20: 52-60.
21. Ibrahim JG and Ryan LM (1996). Use of historical controls in time-adjusted trend tests for carcinogenicity. Biometrics 52: 1478-1485
22. Keenan KP, Laroque P, Ballam GC, Soper KA, Dixit R, Mattson BA, Adams SP, and Coleman JB (1996). The effects of diet, ad libitum overfeeding, and moderate dietary restriction on the rodent bioassay: The uncontrolled variable in safety assessment. Toxicol. Pathol. 24: 757-768.
23. Keenan KP, Smith PF, Hertzog P, Soper K, Ballam GC, and Clark RL (1994). The effects of overfeeding and dietary restriction on Sprague-Dawley rat survival and early pathology biomarkers of aging. Toxicol. Pathol. 22: 300-315.
24. Keenan KP and Soper KA (1995). The effects of ad libitum overfeeding and moderate dietary restriction on Sprague-Dawley rat survival, spontaneous carcinogenesis, chronic disease, and the toxicological response to pharmaceuticals. In: Dietary Restriction: Implications for the Design and Interpretation of Toxicity and Carcinogenicity Studies, RW Hart, DA Neumann, and RT Robertson (eds). International Life Sciences Institute, Washington, DC, pp. 99-126.
25. National Toxicology Program (1994). Comparative Toxicology Studies of Corn Oil, Safflower Oil, and Tricaprylin in Male F344/N Rats as Vehicles for Gavage. Technical Report Series No. 426, NIH Publication No. 94-3157, Department of Health and Human Services, Research Triangle Park, North Carolina.
26. National Toxicology Program (1997). Toxicology and Carcinogenesis Studies of Cobalt Sulfate Heptahydrate in F344/N Rats and B6C3F, Mice. Technical Report Series No. 471, NIH Publication No. 96-3961, Department of Health and Human Services, Research Triangle Park, North Carolina.
27. Nyska A, Leininger JR, Maronpot RR, Haseman JK, and Hailey JR (1998). Effect of individual vs group caging on the incidence of pituitary and Leydig cell tumors in F344 rats: Proposed mechanism. Med. Hypotheses (in press).
28. Pedersen JC, Morrissey RL, Saunders DR, Pavkov KL, Luempert LG, Turnier JC, Matheson DW, and Schwartz DR (1996). A 2-year comparison study of Crl:CD BR and Hsd: Sprague-Dawley SD rats. Fundam. Appl. Toxicol. 33: 196-211.
29. Prentice RL, Smythe RT, Krewski D, and Mason M (1992). On the use of historical control data to estimate dose response trends in quantal bioassay. Biometrics 48: 459-478.
30. Rao GN (1995). Husbandry procedures other than dietary restriction for lowering body weight and tumor/disease rates in Fischer 344 rats. In: Dietary Restriction: Implications for the Design and Interpretation of Toxicity and Carcinogenicity Studies, RW Hart, DA Neumann, and RT Robertson (eds). International Life Sciences Institute, Washington, DC, pp. 51-62.
31. Rao GN and Haseman JK (1993). Influence of corn oil and diet on body weight, survival, and tumor incidences in F344/N rats. Nutr. Cancer 19: 21-30.
32. Rao GN, Haseman JK, Grumbein S, Crawford DD, and Eustis SL (1990). Growth, body weight, survival, and tumor trends in F344/N rats during an eleven year period. Toxicol. Pathol. 18: 61-70.
33. Rao GN and Knapka J J (1987). Contaminant and nutrient concentrations of natural ingredient rat and mouse diet used in chemical toxicology studies. Fundam. Appl. Toxicol. 9: 329-338.
34. Rao GN, Piegorsch WW, and Haseman JK (1987). Influence of body weight on the incidence of spontaneous tumors in rats and mice of long-term studies. Am. J. Clin. Nutr. 45: 252-260.
35. Seilkop SK (1995). The effect of body weight on tumor incidence and carcinogenicity testing in B6C3F, mice and F344 rats. Fundam. Appl. Toxicol. 24: 247-259.
36. Snedecor GW and Cochran WG (1980). Statistical Methods. Iowa State University Press, Ames.
37. Solleveld HA, Haseman JK, and McConnell EE (1984). Natural history of body weight gain, survival, and neoplasia in the F344 rat. J. Natl. Cancer Inst. 72: 929-940.
38. Tamano S, Hagiwara A, Shibata M, Kurata Y, Fukushima S, and Ito N (1988). Spontaneous tumors in aging (C57BL/6N × C3H/HeN)F, (B6C3F,) mice. Toxicol Pathol. 16: 321-326.
39. Tarone RE, Chu KC, and Ward JM (1981). Variability in the rates of some common naturally occurring tumors in Fischer 344 rats and (C57BL/6N × C3H/HeN)F, (B6C3F,) mice. J. Natl Cancer Inst. 66: 1175-1181.
40. Thurman JD, Bucci TJ, Hart RW, and Turturro A (1994). Survival, body weight, and spontaneous neoplasms in ad libitum-kd and food-restricted Fischer-344 rats. Toxicol. Pathol. 22: 1-9.
41. Turturro A, Duffy P. and Hart RW (1995). The effect of caloric modulation on toxicity studies. In: Dietary Restriction: Implications for the Design and Interpretation of Toxicity and Carcinogenicity Studies, RW Hart, DA Neumann, and RT Robertson (eds). International Life Sciences Institute, Washington, DC, pp. 79-98.
42. Ward JM (1983). Background data and variations in tumor rates of control rats and mice. Prog. Exp. Tumor Res. 26: 241-258.
43. Ward JM, Anver MR, Haines DC, and Benveniste RE (1994). Chronic active hepatitis in mice caused by Helicobacter hepaticus. Am. J. Pathol. 145: 959-968.
44. Ward JM, Fox JG, Anver MR, Haines DC, George CV, Collins MJ Jr., Gorelick PL, Nagashima K, Gonda MA, Gilden RV, Tully JG, Russell RJ, Benveniste RE, Paster BJ, Dewhirst FE, Donovan JC, Anderson LM, and Rice JM (1994). Chronic active hepatitis and associated liver tumors in mice caused by a persistent bacterial infection with a novel Helicobacter species. J. Natl Cancer Inst. 86: 1222-1227.
45. Ward JM, Goodman DG, Squire RA, Chu KC, and Linhart MS (1979). Neoplastic and nonneoplastic lesions in aging (C57BL/6N × C3H/HeN)F, (B6C3F,) mice. J. Natl. Cancer Inst. 63: 849-854.
46. Ward JM, Hardisty JF, Hailey JR, and Street CS (1995). Peer review in toxicologic pathology. Toxicol Pathol. 23: 226-234.