Criteria for identifying and classifying carcinogens, mutagens, and teratogens

Broecker, B.; Sowinski, E.J.; Faccini, J. M.; Barr, John T.; Beekhuizen, S. van; Weil, Carrol S.

doi:10.1016/0273-2300(87)90044-4

Cited by 10 publications

(3 citation statements)

References 5 publications

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“…Many tests for genotoxic carcinogens are available (38), but the utility of these tests is restricted to qualitative detection of genotoxic activity. The interpretation of these tests is difficult, since some tests may be positive while others are negative (11,39). It has therefore been concluded that tests of genotoxicity and mutagenicity do not accurately predict the carcinogenicity of most chemicals (38) (although there appears to be good correlation in the case of N-nitrosamines (40)).…”

Section: Estrupolrrtion From Animal Studiesmentioning

confidence: 99%

“…Moreover, the 'weight of evidence' for extrapolation of the carcinogenic response to a drug between species, and especially to man, as evidence of potential human hazard is increased if more than one species develops cancer after exposure to the drug (5,11,1618). It has, for example, been claimed that there is an 85% concordance in the sensitivity and specificity of the effects of carcinogens in two species (16).…”

Section: Hazard Assessmentmentioning

confidence: 99%

“…For example. to estahlish that a drug is somehow involved causally in carcinogenesis, it is necessary to provide clear statistical and biologically significant evidence of an increased incidence of cancer in the treated animals compared with controls (9)(10)(11).…”

Section: Animal Studies Huzard Identificationmentioning

confidence: 99%

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Risks of Therapeutic Achlorhydria

Wormsley

1988

Scandinavian Journal of Gastroenterology

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Wormsley KG. Risks of therapeutic achlorhydria. Scand J Gastroenterol 1988, An analysis has been made of the potential risks involved in the clinical use of the new, powerful gastric secretory inhibitors. These drugs are undoubted carcinogens in animals, although the mechanism underlying the carcinogenic effect has not yet been defined. Prediction of potential human risk depends on whether the results of carcinogenic studies in animals are considered relevant to man. If animal studies are not suitable for extrapolation to man, a lot of time, money, and effort have been wasted, and human beings will have to be (and, regrettably, are being) used as experimental subjects. If the results of the animal studies predict foreseeable human disease, the drugs must not be used, except in the treatment of gastrinomas, since the benefits of use are negligible, while the consequences of releasing a flood of potential gastric carcinogens are intolerable.Scand J Gastroenterol Downloaded from informahealthcare.com by University of British Columbia on 11/18/14For personal use only.Scand J Gastroenterol Downloaded from informahealthcare.com by University of British Columbia on 11/18/14For personal use only.

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Section: Estrupolrrtion From Animal Studiesmentioning

confidence: 99%

Section: Hazard Assessmentmentioning

confidence: 99%

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Risks of Therapeutic Achlorhydria

Wormsley

1988

Scandinavian Journal of Gastroenterology

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Regulations and Guidelines in the Workplace

Bingham¹,

Msph²

2002

Encyclopedia of Agrochemicals

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Occupational diseases can be used as the first historical markers for concern about toxic substances in the workplace. The passage in 1798 of the Act for the Relief of Sick and Disabled Seamen established The Marine Hospital Service, which was later named the Public Health Service. This was the first real legislation that dealt with occupational disease. Research and technology provide the rationale and the methodologies used to develop legislation, regulations, and guidelines that reduced workplace hazards. However, the main factors bringing about the passage of laws and/or regulations are likely to be social. These have included catastrophes, such as mine explosions, asbestos disease, epidemics, and the Gauley bridge episode, political movements such as the environmental and civil rights movements, and organizations capable of pressing for legislation, such as labor organizations, community groups, and trade associations. In the early part of this century, regulations and guidelines to control toxic substances in workplaces emerged out of social forces such as those introduced by labor unions and social reformers. States were at the forefront of early efforts on worker health. Among governmental bodies, the development of guidelines and regulations covering toxic substances was varied. Among the governmental bodies in the United States, the development of guidelines and regulations for toxic substances evolved over the first half of the twentieth century by a fragmented process. Certain states developed both exposure limits and practices for reducing exposures. In the United States, two major sources of numerical limits for various chemical and physical agents were set by ANSI, which is made up of professionals mainly from industry, government, and sometimes academia. ACGIH membership consisted of professionals employed in government (federal, state, or local) and academia, but input was routinely sought from industry specialists. The TLV Committee of the ACGIH, established in 1941, was composed of six nationally recognized industrial hygienists and toxicologists not associated with private industry. TLVs were prepared only for the use of industrial hygienists, who could exercise their own judgment in applying these values. They were not to be used for legal purposes. TLVs are based on the best available information from industrial experience and human and animal experimental studies—when possible, from a combination of these sources. The rationale for choosing limiting values differs from substance to substance. The issue of threshold effects is controversial, and scientists argue for and against threshold theories. Beginning in 1988, concerns were raised by numerous persons regarding the adequacy or health protectiveness of TLVs. The key question raised was, do the TLVs protect enough workers. OELs have also been set by OSHA and NIOSH. Under the OSHAct, exposure limits are set via specific procedures. Criteria documents and literature reviews published by NIOSH serve as a basis for Recommended Exposure Limits (RELs). These RELs provide a scientific basis for OSHA to use in preparing a proposal , however, it should be noted that the constraints in the OSHAct require considering technical and economic feasibility, so that the permissible exposure limits (PELs) that OSHA sets are usually greater than the RELs that are based only on health considerations. Legislation, standards and guidelines the U.S. are discussed. Various U.S. agencies involved in health and safety such as the EPA, Nuclear Regulatory Commission, Department of Transportation are detailed. Other sections involve governmental regulation of toxic chemical in the workplace, exposure prevention guidelines, and global standards.

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Regulations and Guidelines In the Workplace

Bingham¹,

Grimsley²

2001

Patty's Toxicology

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Occupational diseases can be used as the first historical markers for concern about toxic substances in the workplace. The passage in 1798 of the Act for the Relief of Sick and Disabled Seamen established The Marine Hospital Service, which was later named the Public Health Service. This was the first real legislation that dealt with occupational disease. Research and technology provide the rationale and the methodologies used to develop legislation, regulations, and guidelines that reduced workplace hazards. However, the main factors bringing about the passage of laws and/or regulations are likely to be social. These have included catastrophes, such as mine explosions, asbestos disease, epidemics, and the Gauley bridge episode, political movements such as the environmental and civil rights movements, and organizations capable of pressing for legislation, such as labor organizations, community groups, and trade associations. In the early part of this century, regulations and guidelines to control toxic substances in workplaces emerged out of social forces such as those introduced by labor unions and social reformers. States were at the forefront of early efforts on worker health. Among governmental bodies, the development of guidelines and regulations covering toxic substances was varied. Among the governmental bodies in the United States, the development of guidelines and regulations for toxic substances evolved over the first half of the twentieth century by a fragmented process. Certain states developed both exposure limits and practices for reducing exposures. In the United States, two major sources of numerical limits for various chemical and physical agents were set by ANSI, which is made up of professionals mainly from industry, government, and sometimes academia. ACGIH membership consisted of professionals employed in government (federal, state, or local) and academia, but input was routinely sought from industry specialists. The TLV Committee of the ACGIH, established in 1941, was composed of six nationally recognized industrial hygienists and toxicologists not associated with private industry. TLVs were prepared only for the use of industrial hygienists, who could exercise their own judgment in applying these values. They were not to be used for legal purposes. TLVs are based on the best available information from industrial experience and human and animal experimental studies—when possible, from a combination of these sources. The rationale for choosing limiting values differs from substance to substance. The issue of threshold effects is controversial, and scientists argue for and against threshold theories. Beginning in 1988, concerns were raised by numerous persons regarding the adequacy or health protectiveness of TLVs. The key question raised was, do the TLVs protect enough workers. OELs have also been set by OSHA and NIOSH. Under the OSHAct, exposure limits are set via specific procedures. Criteria documents and literature reviews published by NIOSH serve as a basis for Recommended Exposure Limits (RELs). These RELs provide a scientific basis for OSHA to use in preparing a proposal ( 19 ), however, it should be noted that the constraints in the OSHAct require considering technical and economic feasibility, so that the permissible exposure limits (PELs) that OSHA sets are usually greater than the RELs that are based only on health considerations. Legislation, standards and guidelines the U.S. are discussed. Various U.S. agencies involved in health and safety such as the EPA, Nuclear Regulatory Commission, Department of Transportation are detailed. Other sections involve governmental regulation of toxic chemical in the workplace, exposure prevention guidelines, and global standards.

show abstract

Criteria for identifying and classifying carcinogens, mutagens, and teratogens

Cited by 10 publications

References 5 publications

Risks of Therapeutic Achlorhydria

Risks of Therapeutic Achlorhydria

Regulations and Guidelines in the Workplace

Regulations and Guidelines In the Workplace

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