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Setting an indoor air exposure limit for formaldehyde: Factors of concern

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Author: Arts, J.H.E. · Muijser, H. · Kuper, C.F. · Woutersen, R.A.
Institution: TNO Kwaliteit van Leven
Source:Regulatory Toxicology and Pharmacology, 2, 52, 189-194
Identifier: 241100
doi: doi:10.1016/j.yrtph.2008.08.009
Keywords: Health · Toxicology and Applied Pharmacology · Exposure limit · Formaldehyde · Indoor air · Sensory irritation · Air quality standard · Ambient air · Environmental exposure · Eye irritation · Nose irritation · Throat irritation · Administration, Inhalation · Air Pollutants · Carcinogens · Child · European Union · Eye · Formaldehyde · Humans · Inhalation Exposure · Irritants · No-Observed-Adverse-Effect Level · Nose · Occupational Exposure · Pharynx · Trigeminal Nerve


The paper aims to evaluate the indoor air limit of 1 μg/m3 (0.8 ppb) formaldehyde as advised by the European Commission [the INDEX project; Kotzias, D., Koistinen, K., Kephalopoulos, S., Schlitt, C., Carrer, P., Maroni, M., Jantunen, M., Cochet, C., Kirchner, S., Lindvall, T., McLaughlin, J., Mølhave, L., de Oliveira Fernandes, E., Seifert, B., 2005. Critical appraisal of the setting and implementation of indoor exposure limits in the EU. European Commission, Institute for Health and Consumer Protection, Physical and Chemical Exposure Unit, Ispra, Italy, pp. 1-50]. The limit has been based on a nose and throat irritation threshold of 0.1 mg/m3 (0.08 ppm; LOAEL), a NOAEL of 0.03 mg/m3 (0.025 ppm) and an assessment factor of 30, including a factor of 3 for the higher sensitivity of children. Nose and throat irritation, at concentrations below which hyperplasia/metaplasia occurs, are most likely the manifestation of trigeminal nerve stimulation (sensory irritation). The threshold for sensory irritation in human volunteers is 1 ppm, much higher than the 0.1 mg/m3 indicated above. Eye irritation is the most sensitive effect reported in human volunteers but has been mentioned only occasionally in the studies used by the European Commission. Moreover, sensory irritation is a local reaction that requires a low assessment factor, if any. It is difficult to judge the sensitivity for sensory irritation in children because of the potential confounding factors in the evaluated studies. It is concluded that an indoor air level of 0.1 ppm (0.12 mg/m3) formaldehyde, as indicated by Appel et al. (2006) [Appel, K.E., Bernauer, U., Herbst, U., Madle, S., Schulte, A., Richter-Reichhelm, H.B., Gundert-Remy, U. 2006. Kann für Formaldehyd eine "sichere" Konzentration abgeleitet werden?-Analyse der Daten zur krebserzeugenden Wirkung (Can a "safe" concentration be established for formaldehyde?-Analysis of carcinogenicity data)? Umweltmed. Forsch. Prax. 11, 347-361], can be considered a safe and appropriate level. © 2008 Elsevier Inc. All rights reserved. Chemicals / CAS: formaldehyde, 50-00-0; Air Pollutants; Carcinogens; Formaldehyde, 50-00-0; Irritants