home edit2 whole TSD November 2002 PDF format - OEHHA

pool only when the tumor site had statistically significantly increased incidence at least at the high dose
level (treated vs. control). The female rat was considered to be the more sensitive sex, as there were
significantly increased tumor incidences at a greater number of sites than in the males; the female rat
tumor data was therefore used as the basis of a risk estimate. A linearized multistage procedure
(GLOBAL 83) was used to calculate a cancer potency factor (q 1 * ) from the female rat tumor incidence
data. Surface area scaling was employed to transform animal cancer potency factors to human cancer
potency factors, using the relationship (q human = q animal * (bw h / bw a ) 1/3 ), where q human is the human
potency, q animal is the animal potency, and bw h and bw a are the human and animal body weights,
respectively. Body weight values used for humans and rats were 70 kg and 0.2 kg, respectively. No
exposure route adjustment was made to the risk estimates because data exists which indicates that the
pharmacokinetics and tissue distribution of acrylamide were not significantly affected by the dose
administered or the route of administration (Dearfield et al., 1988). US EPA calculated a cancer
potency value (q human ) of 4.5 E+0 (mg/kg-day) -1 . A unit risk factor was then calculated from the cancer
potency factor by OEHHA/ATES using a reference human body weight of 70 kg and an inspiration rate
of 20 m 3 /day. The unit risk should not be used if the air concentration exceeds 8 µg/m 3 , as above this
concentration the unit risk may not be appropriate.
V. REFERENCES
Bull RJ, Robinson M, Laurie RD, Stoner GD, Greisiger EA, Meier JR and Stober J. 1984.
Carcinogenic effects of acrylamide in Sencar and A/J mice. Cancer Res 44:107-111.
Bull RJ, Robinson M and Stober JA. 1984. Carcinogenic activity of acrylamide in the skin and lung of
Swiss-ICR mice. Cancer Lett 24:209-212.
California Department of Health Services 1990. Intakes Posing 10 -5 Cancer Risk for 11 Proposition
65 Carcinogens: Acrylamide. Reproductive and Cancer Hazard Assessment Section, Berkeley, CA.
Collins JJ. 1984. A Proportional Mortality Ratio Analysis of Workers Exposed to Acrylamide at the
Warners Plant. Epidemiology Section, American Cyanamid Company.
Dearfield KL, Abernathy CO, Ottley MS, Brantner JH and Hayes PF. 1988. Acrylamide: its
metabolism, developmental and reproductive effects, genotoxicity and carcinogenicity. Mutat Res
195:45-77.
Hazardous Substance Data Bank (HSDB) 1994. National Library of Medicine, Bethesda MD (CD-
ROM Version). Micromedix, Inc., Denver CO, Edition 22.
Johnson KA, Gorzinski SJ, Bodner KM, Campbell RA, Wolf CA, Friedman MA and Mast RW.
1986. Chronic toxicity and oncogenicity study on acrylamide incorporated in the drinking water of
Fischer 344 rats. Toxicol Appl Pharmacol 85:154-168.
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