Carcinogenicity regulation

Roberts, R.A., K.S. Crump, W.K. Lutz, et al. 2001. Scientific analysis of the proposed uses of the T25 dose descriptor in chemical carcinogen regulation. An ECETOC Workshop overview. Arch. Toxicol. 75 507-512. 

Cross, Frank B., Daniel M. Byrd III, and Lester B. Lave. 1991. Discernible Risk—A Proposed Standard for Significant Risk in Carcinogen Regulation. Administrative Law Review 43 (Winter) 61-88. 

Kraus, A.L., Munro, I.C., Orr, J.C., Binder, R.L., LeBoeuf, R.A. Williams. GM. (1995) Benzoyl peroxide an integrated human safety assessment for carcinogenicity. Regul. Toxicol. Pharmacol., 21, 87-107... 

For any hazardous substance, estimates of the relationship of dose to response in humans are based on either animal or human data. For example, only about 20 of the approximately 300 chemical carcinogens regulated by EPA have dose-response relationships based on human data from epidemiologic studies the remainder are based on animal bioassays. In contrast, the dose-response relationships for radiation are based primarily on the results of human epidemiologic studies. 

BARR, J. (1988). Design and interpretation of bioassays for carcinogenicity, Regul. Toxicol. Pharmacol. 7, 422-426. 

Potential occupational carcinogens regulated under OSHA are classified into two main categories based on the nature and extent of the available scientific evidence category I potential carcinogens and category II potential carcinogens. 

Mayer, J., Cheeseman, M. A., and Twaroski, M. L. (2008). Structure-activity relationship analysis tools Validation and applicability in predicting carcinogens. Regul Toxicol Pharmacol 50, 50-58. 

U.S. Department of Health, Education, and Welfare (DHEW), Public Health Service, Center fcr Disease Control, National Institute for Occupational Safety and Health. 1977. Carcinogens—Regulation... 

TABLE 4.3.1.1 Chemical Carcinogens Regulated by the Occupational Safety and Health Administration ... 

When equipment, materials, or other items are taken into or removed from a carcinogen-regulated... 

When equipment, materials, or other items are taken into or removed from a carcinogen regulated area, is it done in a manner that will contaminate nonregulated areas or the external environment ... 

Since 1979 the use of 24 5 T has been regu lated in the United States It is likely that the United States Environmental Protection Agency will classify some dioxins as known and others as probable human carcinogens and recommend further controls be placed on processes that produce them It appears from decreasing dioxin levels in some soils that exist mg regulations are having some effect ... 

Colorants. According to U.S. regulations, colorants are divided into two classes certified and exempt (see Colorants for foods, drugs, COSMETICS, AND MEDICAL DEVICES). Batch samples of certified colors must be sent to the FDA for analysis and confirmation that the colorants comply with estabhshed specifications. Color manufacturers pay a small fee for each batch of color that is analy2ed. The number of certified colors available to food technologists has declined. Several of the historical colorants were found to have carcinogenic effects. Table 1 shows the certified colors that are permissible for food use in the United States as of 1993. 

The odor threshold for detection of ethyleneimine is 2 ppm. The maximum permissible concentration of ethyleneimine in the air at the place of work is 0.5 ppm (as specified in statutory regulations in the United States (374) and in Germany (375)). Animal experiments have shown ethyleneimine to be both carcinogenic (376) and mutagenic (377) (Table 2). 

In the European Union, coal-derived complex chemical substances, ie, those contained in the European Inventory of Existing Commercial Chemical Substances, have been classified for carcinogenicity in the twenty-first adaptation to technical progress of the European Commission (EC) Dangerous Substances Directive 1994 67/548/EEC (57). The EC Regulation 793/93 requires data sets to be submitted by producers or importers to the... 

Swallowing. If it is sufficiently irritant or caustic, a swallowed material may cause local effects on the mouth, pharynx, esophagus, and stomach. Additionally, carcinogenic materials may induce tumor formation in the alimentary tract. Also, the gastrointestinal tract is an important route by which toxic materials are absorbed. The sites of absorption and factors regulating absorption have been reviewed (42,43). 

Trichloroethylene use has declined as a result of environmental concerns. However, trichloroethylene may replace some 1,1,1-trichloroethane appHcations. Perchloroethylene used in small businesses for dry cleaning will be regulated for emissions under the same guidelines as those that govern the large chemical producers. This will cause replacement of perchloroethylene for those appHcations where recovery is uneconomical. Methylene chloride has been classified as a suspected carcinogen and its use will decline in aerosol and paint stripping appHcations because of health concerns. 

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