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Meeting report: summary of IARC Monographs on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol

Environmental Health Perspectives, Sept, 2005 by Vincent James Cogliano, Yann Grosse, Robert A. Baan, Kurt Straif, Marie Beatrice Secretan, Fatiha El Ghissassi

An international, interdisciplinary working group of expert scientists met in June 2004 to develop IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans (IARC Monographs) on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol. Each IARC Monograph includes a critical review of the pertinent scientific literature and an evaluation of an agent's potential to cause cancer in humans. After a thorough discussion of the epidemiologic, experimental, and other relevant data, the working group concluded that formaldehyde is carcinogenic to humans, based on sufficient evidence in humans and in experimental animals. In the epidemiologic studies, there was sufficient evidence that formaldehyde causes nasopharyngeal cancer, "strong but not sufficient" evidence of leukemia, and limited evidence of sinonasal cancer. The working group also concluded that 2-butoxyethanol and 1-tert-butoxy-2-propanol are not classifiable as to their carcinogenicity to humans, each having limited evidence in experimental animals and inadequate evidence in humans. These three evaluations and the supporting data will be published as Volume 88 of the IARC Monographs. Key words: 1-tert-butoxy-2-propanol, 2-butoxyethanol, carcinogen, formaldehyde, glycol ethers, hazard identification, IARC Monographs, leukemia, nasopharyngeal cancer, sinonasal cancer. doi:10.1289/ehp.7542 available via http://dx.doi.org/[Online 12 May 2005]

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Twenty-six scientists from 10 countries met at the International Agency for Research on Cancer (IARC) in June 2004 to develop IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans (IARC Monographs) on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol (IARC, in press). This is the fourth IARC evaluation of formaldehyde and the first of the glycol ethers.

Formaldehyde is widely used in resins that bind wood products, pulp and paper, and glasswool and rockwool insulation. It is also used in plastics and coatings, textile finishing, and chemical manufacturing and as a disinfectant and preservative. High concentrations can be found in some work environments, and much lower concentrations in homes.

2-Butoxyethanol is a glycol ether widely used as a solvent in paints, paint thinners, glass-cleaning and surface-cleaning products (especially in the printing and silk-screening industries), and personal-care and other personal products and as a chemical intermediate. General-population exposure can occur through the use of consumer products, particularly cleaning agents.

1-tert-Butoxy-2-propanol is a glycol ether that has found increasing use as a solvent in coatings, glass-cleaning and surface-cleaning products, inks, adhesives, and nail-polish lacquers.

Materials and Methods

IARC convenes an international, interdisciplinary working group of expert scientists to develop each volume of the IARC Monographs. The working group writes a critical review of the pertinent scientific literature (published articles, articles accepted for publication, and publicly available documents from government agencies) and a consensus evaluation of each agent's potential to cause cancer in humans.

The IARC Monographs are developed during an 8-day meeting whose objectives are review and consensus. Before the meeting, each member of the working group writes a portion of the critical review. At the meeting, four subgroups (exposure, cancer in humans, cancer in experimental animals, and mechanistic and other relevant data) review these drafts and develop consensus subgroup drafts. Then the working group meets in plenary session to review the subgroup drafts and develop a consensus evaluation. After the meeting, IARC scientists review the final draft for accuracy and clarity before publication.

The evaluation is developed in steps (IARC 2005). The subgroup of epidemiologists proposes an evaluation of the evidence of cancer in humans as sufficient evidence, limited evidence, inadequate evidence, or evidence suggesting lack of carcinogenicity. A subgroup of toxicologists and pathologists proposes an evaluation of the evidence of cancer in experimental animals, choosing one of the same descriptors. Combination of these two partial evaluations yields a preliminary default evaluation that the agent is one of the following: group 1, carcinogenic to humans; group 2A, probably carcinogenic to humans; group 2B, possibly carcinogenic to humans; group 3, not classifiable as to its carcinogenicity to humans; or group 4, probably not carcinogenic to humans.

When the epidemiologic evidence is sufficient, the final evaluation is carcinogenic to humans, regardless of the experimental evidence. In other cases, the mechanistic and other relevant data are considered to determine whether the default evaluation should be modified upward or downward. A subgroup of experts in cancer mechanisms assesses the strength of the mechanistic data and whether the mechanisms of tumor formation in experimental animals can operate in humans. The overall evaluation is a matter of scientific judgment, reflecting the combined weight of the evidence.

Meeting report: summary of IARC Monographs on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol

Environmental Health Perspectives, Sept, 2005 by Vincent James Cogliano, Yann Grosse, Robert A. Baan, Kurt Straif, Marie Beatrice Secretan, Fatiha El Ghissassi

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