Table 21.
Summary of select neoplasms in female rats (Studies 1–8).
| Tumor Incidence/number of animals examined, by dose (mg/kg bw/day) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Select neoplasm | Controls – 0 [% range for studies] | a3 | d7.4 | c10 | a11 | a34 | d73.9 | c100 | h105 | b113 | f115 | g145 | ||
| Pancreas islet cell adenoma | 11/397 [0–9] | 1/50 | 0/23 | 2/27 | 1/50 | 0/49 | 0/16 | 2/29 | 0/51 | 1/60 | 2/79 | 0/63 | ||
| Pituitary adenoma | 246/397 [14–78] | 29/48 | 13/33 | 19/28 | 31/50 | 26/49 | 7/23 | 19/29 | 23/51 | 48/60 | 54/79 | 44/63 | ||
| Pituitary carcinoma | 16/155 [2–17] | 7/48 | NF | 5/28 | 5/50 | 12/49 | NF | 5/28 | NF | 0/60 | NF | NF | ||
| Thyroid C cell adenoma | 25/302 [3% – 16%] | 3/49 | 0/24 | 1/27 | 6/50 | 3/47 | 1/17 | 1/29 | # 1/51 | 2/60 | 7/78 | # 0/63 | ||
| Hepatocellular adenoma | 22/302 [0–36] | NF | 18/48 | 1/50 | NF | NF | 19/49 | 3/50 | 0/51 | 2/60 | 1/79 | 0/64 | ||
| Hepatocellular carcinoma | 14/210 [0–20] | 0/50 | 15/48 | 0/50 | 0/50 | 2/50 | 14/49 | 0/50 | 0/51 | 0/60 | NF | NF | ||
| Mammary gland fibroadenoma | 113/384 [6–58] | 16/46 | NF | 12/28 | 20/48 | 16/44 | NF | 17/29 | 9/51 | $24/54 | 30/79 | 4/63 | ||
| Mammary gland adenocarcinoma | 40/334 [2–22] | 6/46 | 0/30 | NF | 5/48 | 8/44 | 0/33 | NF | 3/51 | ∼10/54 | 8/79 | 0/63 | ||
| Tumor Incidence/number of animals examined, by dose (mg/kg bw/day) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Select neoplasm | e210 | c300 | h349 | f393 | g437 | b457 | d740.6 | c1000 | e1060 | b1183 | f1247 | h1382 | g1498 | e1740 |
| Pancreas islet cell adenoma | NF | 2/29 | 0/51 | 1/78 | 1/64 | 4/60 | 1/49 | 1/49 | NF | 0/59 | 1/78 | 0/51 | 0/64 | NF |
| Pituitary adenoma | NF | 25/30 | 16/51 | 47/77 | 46/63 | 46/60 | 6/50 | 34/49 | NF | 34/59 | 52/78 | 32/51 | 49/64 | NF |
| Pituitary carcinoma | NF | 2/30 | NF | NF | NF | 0/60 | NF | 7/49 | NF | 1/59 | NF | NF | NF | NF |
| Thyroid C cell adenoma | NF | 2/29 | #1/50 | 8/76 | #0/64 | 6/60 | 1/47 | 7/49 | NF | 6/60 | 4/78 | # 0/51 | # 2/64 | NF |
| Hepatocellular adenoma | NF | 1/50 | 1/51 | 0/78 | 1/64 | 6/60 | 13/50 | 2/50 | NF | 1/60 | 0/78 | 1/51 | 0/64 | NF |
| Hepatocellular carcinoma | NF | 0/50 | 1/51 | NF | NF | 1/60 | 9/50 | 0/50 | NF | 2/60 | NF | 0/51 | NF | NF |
| Mammary gland fibroadenoma | 1/22 | 19/30 | 7/51 | 27/77 | 6/64 | $27/59 | NF | 29/50 | 5/22 | $28/57 | 30/78 | 5/51 | 5/64 | 5/50 |
| Mammary gland adenocarcinoma | 0/22 | NF | 1/51 | 11/77 | 0/64 | ∼14/59 | 0/48 | NF | 0/22 | ∼9/57 | 8/78 | 6/51 | 2/64 | 0/50 |
aStudy 1 (Monsanto) (CD) SD rats, rated unreliable for carcinogenicity evaluation.
bStudy 2 (Monsanto) (CD) SD rats, including interim sacrifice groups.
cStudy 3 (Cheminova) SD rats.
dStudy 4 (Feinchemic Schwebda) Wistar rats.
eStudy 5 (Excel) SD rats, rated unreliable for carcinogenicity evaluation.
fStudy 6 (Arysta Life Sciences) Crj:CD SD rats, including interim sacrifice groups.
gStudy 7 (Syngenta) Alpk:APfSD Wistar rats, including interim sacrifice groups.
hStudy 8 (Nufarm) Wistar Han Crl:WI rats.
$Recorded as adenoma/adenofibroma/fibroma.
∼Recorded as carcinoma/adenocarcinoma.
NF not found/not reported.