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IV.<br />

DERIVATION OF CANCER POTENCY<br />

Basis for Cancer Potency<br />

The study by NTP (1987) was chosen by CDHS (1988) as the key study for the development of a<br />

cancer potency value for 1,4-DCB. In the NTP (1987) study, mice and rats exhibited significant<br />

increases in several types of tumors. The mice were exposed for 5 days/week, resulting in average daily<br />

doses of 0, 214, and 428 mg/kg/day 1,4-DCB. Mice of either sex exhibited a significant increase in<br />

hepatocellular carcinomas or adenomas. The incidence of hepatocarcinomas or adenomas was 17/50,<br />

22/49, and 40/50 in the control, 214, and 428 mg/kg/day groups, respectively. In addition, male rats<br />

showed a significant increase in kidney adenomas and mononuclear cell leukemia. The cancer potency<br />

for 1,4-DCB was calculated from the male mouse hepatocarcinoma and adenoma data.<br />

Methodology<br />

A linearized multistage procedure was used to estimate the cancer potency of 1,4-DCB from the NTP<br />

(1987) data in male B6C3F1 mice (Crump et al., 1982). The concentrations of 1,4-DCB given in the<br />

feed were 0, 214, or 428 mg/kg/day. The premature mortality of animals without tumors was<br />

subtracted from the sample groups. The 95% upper confidence bound on the dose-response slope was<br />

used to derive the human cancer potency value.<br />

The animal cancer potency, q animal , was calculated from the linear slope using the lifetime scaling factor<br />

q animal = q 1 * × (T/T e ) 3 , where T/T e is the ratio of the experimental duration to the lifetime of the animal.<br />

In this case, the scaling factor was equal to 1. An estimated value for the human cancer potency was<br />

determined using the relationship q human = q animal × (bw h /bw a ) 1/3 , where bw is the default body weight<br />

of human or animal (mouse).<br />

Using these relationships, a human cancer potency (q human ) of 0.04 [mg/kg-day] -1 was calculated<br />

(CDHS, 1988). An airborne unit risk factor of 1.1E-5 (µg/m 3 ) -1 was calculated by <strong>OEHHA</strong>/ATES<br />

from the q human value using the default parameters of 70 kg human body weight and 20 m 3 /day breathing<br />

rate.<br />

V. REFERENCES<br />

California Department of Health Services (CDHS). 1985. Guidelines for Chemical Carcinogen Risk<br />

Assessment and their Scientific Rationale. State of California Health and Welfare Agency, Department<br />

of Health Services, 2151 Berkeley Way, Berkeley, CA..<br />

California Department of Health Services (CDHS). 1988. Proposed Maximum Contaminant Level: 1,4-<br />

Dichlorobenzene (para-Dichlorobenzene). Hazard Evaluation Section, Department of Health Services,<br />

2151 Berkeley Way, Berkeley, CA.<br />

Crump KS. 1982. An improved procedure for low-dose carcinogenic risk assessment from animal<br />

data. J Environ Path Toxicol 5(2):675-684.<br />

245

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