Ml. Dourson et al., CATEGORICAL REGRESSION OF TOXICITY DATA - A CASE-STUDY USING ADICARB, Regulatory toxicology and pharmacology, 25(2), 1997, pp. 121-129
Categorical regression is a mathematical tool that can be adapted to e
stimate potential health risk from chemical exposures. By regressing o
rdered categories of toxic severity or pathological staging on exposur
e dose, this method can estimate the likelihood of observing any of th
e categories of severity at any dose level. Depending on the nature of
the available data, these estimates can take the form of incidence ra
tes for any of the categories in an exposed population or the probabil
ity of a new study conducted at a specified dose level being classifie
d as one of the categories, Categorical regression is illustrated usin
g toxicity data on aldicarb, For aldicarb, the data fall into three di
fferent groups: human clinical studies, dietary exposures in experimen
tal animals, and accidental human exposure by contaminated crops. The
U.S. EPA has assessed this literature and developed a reference dose (
RfD) of 0.001 mg/kg-day. The results of applying categorical regressio
n to data from human clinical studies suggests a maximum likelihood ri
sk estimate of adverse effects of 0.008% at a 10-fold higher dose than
the RfD when blood cholinesterase inhibition is not considered as an
adverse effect, When blood cholinesterase inhibition of 20% or more is
considered as an adverse effect, a maximum likelihood risk estimate o
f adverse effects is 0.1% at a dose 10-fold higher than the RfD. (C) 1
997 Academic Press.