Table 3.
Summary of the animal studies used to derive PODs for each of the toxicities reviewed in RA1.
| Toxic effect | Oral exposure duration (vehicle) | Species | NOAEL/LOAEL (mg/kg bw per day) | Calculated BMD/BMDL# (mg/kg bw per day) | Reference |
|---|---|---|---|---|---|
| Reproductive toxicity | Subchronic (corn oil) | Male rat | NA/1 | No dose–response | Zheng et al. (2010) |
| Neuro-developmental toxicity | Acute (peanut oil) | Male & female rat | 0.02/0.2 | 0.09/0.05 (0.02†) | Chen et al. (2012) |
| Hepatotoxicity | Subchronic (soybean oil) | Male & female rat | NA/3 | No dose–response | Wester et al. (2012) |
| Renal toxicity | Subchronic (peanut oil) | Male rat | 5/50 | Data not available | Knuckles et al. (2001) |
| Cardiovascular toxicity | Chronic (olive oil) | Male mouse | NA/2.5 | No dose–response | Yang et al. (2009) |
| Immunotoxicity | Subchronic (soybean oil) | Male rat | 3/10 | 14/8.9 (4.8†) | De Jong et al. (1999) |
| Liver mutations | Subchronic (olive oil) | Male mouse | NA/25 | 2.2/1.4 | Lemieux et al. (2011) |
| Lung mutations | Subchronic (olive oil) | Male mouse | NA/25 | 7.2/4.8 | Lemieux et al. (2011) |
| Forestomach mutations | Subchronic (olive oil) | Male mouse | NA/25 | 0.5/0.3 | Lemieux et al. (2011) |
| Liver tumors | Chronic (soybean oil) | Male & female rat | *2.1/7.1 | *3.3/2.4 (1.2†) | Wester et al. (2012) |
| Forestomach tumors | Chronic (soybean oil) | Male & female rat | *NA/2.1 | *1.5/0.8 (1.1†) | Wester et al. (2012) |
| Forestomach tumors | Chronic (diet) | Female mouse | 0/0.65 | 0.8/0.5 | Culp et al. (1998) |
Dose adjustment for time (dose × 5/7 dosing days) before modeling.
For comparison of rat and mouse BMDLs, scaled from rat to mouse by multiplying rat values by (0.03/0.35)¼ based on the assumption that the physiological processes scale with body weight to the ¾ power (allometric scaling).
Benchmark response: BMD10/BMDL10 for quantal data (tumor) and BMD1SD/BMDL1SD continuous data (Neurotoxicity, immunotoxicity and genotoxicity). Refer to supplemental table 4 for BMD model fit data.
NA, not available