Table 6.
Study Type | Study outcome | ExpoCast upper 95% CI on predicted exposure (mg/kg/day) for the total U.S. population (mg/kg bw/day) | MOE |
---|---|---|---|
Uterotrophic Assay |
Effect Level: LEL = 100 mg/kg-bw/day Result: 1.3 fold increase relative to control; subcutaneous injection (s.c.) over 3 days; Crj:CD(SD) Rat Source: NICEATM DB (Kleinstreuer et al. 2015) |
0.0048 | 20830ǂ |
2-Generation Reproductive Toxicity study (OECD 416) |
Effect Level: NOAEL/LOAEL: 70/200 mg/kg-bw/day Study design: S.D. rats; 0, 800, 2500 and 7500 ppm corresponding to 0, 70, 200 and 600 mg/kg bw/day in diet. Result: Increased vaginal epithelium atrophy, reduced relative weight of ovaries, and reduced relative weight of adrenal glands in females Source: (EU 2008) |
0.0048 | 14580 (NOAEL) 41670 (LOAEL) |
Note: This value is illustrative only. In practice, the uterotrophic assay would not typically be used to generate an MOE.