19085-1701857-UL_Prop_65_Test_Results_2019

CA Prop 65 Cumene NSRL February 11, 2019 Page 11 | 12
Table A1. Inhalation Lifetime Average Daily Dose
Sex, strain, species
Administered dose
(mg/m
3
)
Body weight
(kg)
Lifetime Average daily dose
(mg/kg-day)
Male B6C3F
1
Mice
0, 1229, 2458, 4916
0.044
0, 27.8, 55.6, 111.3
Female B6C3F
1
Mice
0, 614.5, 1229, 2458
0.043
0, 22.4, 44.8, 89.7
Male F344/DuCrj (SPF)
Rats
0, 1229, 2458, 4916 0.410 0.0, 1278.3, 2556.7, 5113.4
Female F344/DuCrj
(SPF) Rat
0, 1229, 2458, 4916 0.251 0.0, 938.3, 1876.7, 3753.3
From the animal cancer potency value, a human cancer potency is obtained, assuming the
interspecies conversion set out in Proposition 65 regulations (Title 22, California Code of
Regulations, section 12703). Following these regulations, a dose in units of milligram per unit
surface area is assumed to produce the same degree of cancer effect in different species in the
absence of information indicating otherwise. However, when available data are of such quality
that physiologic, pharmacokinetic, and metabolic considerations can be considered with
confidence, they may be used in the risk assessment for inter-species, inter-dose, and inter-
route extrapolations.
Therefore, scaling to the estimated human CSF (CSF
human
) is achieved by multiplying the animal
CSF (CSF
animal
) by the ratio of human to animal body weights (bw
h
/bw
a
) raised to the one-fourth
power. Thus, the estimated human CSF becomes a product of the following expression, where
bw
human
and bw
animal
are the body weights of humans (70 kg) and the respective test animal body
weight (Table A1):
CSF

= CSF

x allometric scaling
Which corresponds to:
CSF

= CSF

x 



/

/
(Equation A3)