Table 3.
Examples of guideline-compliant BPA studies
| Study | Design | Result | Reference |
|---|---|---|---|
| Three-generation reproductive toxicity study in rats | • Six BPA dose groups (0.001–500 mg/kg/day; administration in diet); | • No effects in the low- dose range (0.001–5 mg/kg/day) | Tyl et al., 2002 |
| • OPPTS guideline 870.03800 | • Reduced body and organ weights at 350 mg/kg/day | ||
| • Effects on renal and hepatic histopathology: 500 mg/kg/day | |||
| • Reproductive and developmental toxicity: 500 mg/kg/day | |||
| • At doses <500 mg/kg/day: no effects on prostate weights, acquisition of puberty | |||
| • Systemic NOAEL: 5 mg/kg/day | |||
| • Reproductive NOAEL: 50 mg/kg/day | |||
| Two-generation rat study | • Daily gavage doses of 0.0.2–200 µg/kg/day | • No effect at any dose (consider that this is a low-dose study with 0.2 mg/kg/day as the highest dose) | Ema et al., 2001 |
| • US EPA GLPs and OPPTS TG with added endocrinesensitive and neurobehavioral end points | |||
| One- and two-generation reproductive toxicity studies in mice | • Two vehicle control groups, six BPA dose groups (0.003–600 mg/kg/day; administration in diet) | • No effects in the low-dose range (0.003–5 mg/kg/day) | Tyl et al., 2008a, 2008b, 2008c |
| • Dietary estradiol as positive control (0.2 µg/kg/day to 8 mg/kg/day) | • Reduced body weights, increased renal and liver weights and further effects at 600 mg/kg/day. However, no adverse effects on adult reproductive structures or functions at 600 mg/kg/day. | ||
| • OECD GLPs | |||
| • Effects on liver histopathology at 50 mg/kg/day | |||
| • Systemic NOAEL: 5 mg/kg/day | |||
| • Reproductive NOAEL: 50 mg/kg/day | |||
| Developmental neurotoxicity study in rats | • Dietary administration of 0, 0.01, 0.1, 5, 50, and 150 mg/kg/day (mean target doses) from gestation day 0 through lactation day 21. Evaluation of F1 offspring. | • No treatment-related neurobehavioral effects | Stump et al., 2010 |
| • OECD test guideline 426 | • No evidence of neuropathology and no effects on brain morphometry | ||
| • NOAEL for systemic toxicity derived from maternal and offspring body weight reductions: 5.85 and 13.1 mg/kg/day (calculated) during gestation and lactation, respectively |