Quantitative risk assessment for a glass fiber insulation product

Regulatory Toxicology and Pharmacology : RTP
William E FayerweatherWalter Eastes

Abstract

California Proposition 65 (Prop65) provides a mechanism by which the manufacturer may perform a quantitative risk assessment to be used in determining the need for cancer warning labels. This paper presents a risk assessment under this regulation for professional and do-it-yourself insulation installers. It determines the level of insulation glass fiber exposure (specifically Owens Corning's R-25 PinkPlus with Miraflex) that, assuming a working lifetime exposure, poses no significant cancer risk under Prop65's regulations. "No significant risk" is defined under Prop65 as a lifetime risk of no more than one additional cancer case per 100,000 exposed persons, and nonsignificant exposure is defined as a working lifetime exposure associated with "no significant risk." This determination can be carried out despite the fact that the relevant underlying studies (i.e., chronic inhalation bioassays) of comparable glass wool fibers do not show tumorigenic activity. Nonsignificant exposures are estimated from (1) the most recent RCC chronic inhalation bioassay of nondurable fiberglass in rats; (2) intraperitoneal fiberglass injection studies in rats; (3) a distributional, decision analysis approach applied to four chronic inhalation rat b...Continue Reading

References

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Citations

Jul 14, 2006·Regulatory Toxicology and Pharmacology : RTP·L Daniel MaximRon Niebo
Aug 28, 1999·Regulatory Toxicology and Pharmacology : RTP·L D MaximJ E Cason
Feb 16, 2002·Regulatory Toxicology and Pharmacology : RTP·Martin A MooreJay Turim
Feb 16, 2002·Regulatory Toxicology and Pharmacology : RTP·Alexander M WalkerMark Utell
Jul 21, 1999·Human & Experimental Toxicology·M RuotsalainenK M Savolainen
Oct 3, 2000·Inhalation Toxicology·J E Swauger, J W Foy
Apr 15, 2010·Inhalation Toxicology·Mark J Utell, L Daniel Maxim
Jul 6, 2000·Inhalation Toxicology·R W MastA M Walker

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