Table 3.
Estimated chronic steady‐state body burdens of TCDD and corresponding estimated human daily intakes (EHDI) at NOAEL and LOAELs in the pivotal studies (SCF, 2001)
Study | Endpoint | NOAEL | LOAEL | Estimated maternal steady‐state body burdena (ng/kg bw) | Associated EHDId (pg/kg bw per day) |
---|---|---|---|---|---|
Mably et al. (1992a) | Holzman rats: decreased sperm count in male offspring | – | 64 ng/kg bw single bolus dose by gavage | 100b | 50 |
Gray et al. (1997a) | Long‐Evans rats: accelerated eye opening and decreased sperm count in male offspring | – | 50 ng/kg bw single bolus dose by gavage | 80b | 40 |
Faqi et al. (1998) | Wistar rats: decreased sperm production and altered sexual behaviour in male offspring | – | Maintenance of 25 ng/kg bw by s.c. injections | 40b | 20 |
Ohsako et al. (2001) | Holzman rats: decreased anogenital distance in male offspring | 12.5 ng/kg bw single bolus dose by gavage | – | 20c | 10 |
– | 50 ng/kg bw single bolus dose by gavage | 80c | 40 |
bw: body weight; GD: gestation day; LOAEL: lowest‐observed‐adverse‐effect level; NOAEL: no‐observed‐adverse‐effect level; TCDD: 2,3,7,8‐ tetrachlorodibenzo‐p‐dioxin; s.c.: subcutaneous.
Increment over background. Estimated background body burden from feed in rats is approximately 4 ng TEQ/kg bw (WHO, 2000). The maternal body burdens were increased by a factor of 2.6 for the difference in the ratio between levels in the fetus and mother after a single vs repeated dose.
Composite value resulting from pseudo steady‐state body burden and acute body burden on GD15.
Maternal body burden at GD16.
Estimated chronic Human Daily Intake.