POD--chosen point of departure of OEL process (a NOAEL, LOAEL
or a BMD),
present in the food above established LOAELs
. Label does not overwarn to
We divide the NOAEL or LOAEL
by the uncertainty factor.
PoD = Point-of-departure (NOAEL or LOAEL
Analysis of 204 monographs of Polish occupational exposure limits prepared in 2002 to 2013 shows that for the 169 substances, the proposed value of the maximum admissible concentration is based on the LOAEL
or NOAEL published in the literature (Table 1 and 2).
Several studies during the last two decades provide for the determination of Lowest Observed Adverse Effect Levels (LOAELs
) or No Observed Adverse Effect Levels (NOAELs) for neurological effects in workers exposed to Mn in settings such as smelters, dry alkaline battery manufacturing facilities, and ferromanganese alloy production plants (33,34,52,62,82,88,99,107-114).
Of note is that if the POD was a LOAEL
, there were two adjustments-one based on how much lower the NOAEL might be, and a second one based on what the BMD might be for a given NOAEL.
tolerated dose (human) 0.536 0.925 Oral Rat Acute Toxicity (LD50) 1.975 1.962 Oral Rat Chronic Toxicity (LOAEL
) 1.728 2.290 Hepatotoxicity No No Skin sensitisation No No Predicted properties Meglumine antimoniate Absorption Caco2 permeability -0.443 Intestinal absorption 27.93 Skin Permeability -2.893 P-Glycoprotein substrate Yes P-Glycoprotein inhibitor No Distribution Volume of distribution -0.35 Fraction unbound (human) 0.985 BBB permeability -1.287 CNS permeability -4.761 Metabolism CYP3A4 substrate No CYP2D6 substrate No CYP3A4 inhibitor No CYP2D6 inhibitor No CYP1A2 inhibitor No Excretion Total clearance -0.154 Toxicity AMES toxicity No Max.
: 49 [micro]g/[m.sup.3] (0,6 x [10.sup.6] czastek/[cm.sup.3] i 1,08 x [10.sup.9] [nm.sup.2]/[cm.sup.3]).
D--max 3--extrapolation from the lowest-observed-adverse effect level (LOAEL
) to NOAEL,
Methodological differences related to the use of benchmark dose rather than the lowest observed adverse effect level (LOAEL
), the study of small-sized populations or analytical aspects such an insufficient adjustment for variations in diuresis, might account for part of the variation in these estimates.
The Agency for Toxic Substances & Disease Registry (ATSDR) determined the lowest-observed adverse-effect level (LOAEL
) for intermediate-duration exposure (15-364 d) of DBT in rodents as 5 mg/kg/day (ATSDR 2005).