title: Lowest adverse effects concentrations (LOAECs) for formaldehyde exposure.
abstract: In 2012 the Committee for Risk Assessment (RAC) of the European Chemicals Agency concluded that 2ppm formaldehyde represent a Lowest Observed Adverse Effect Concentration (LOAEC) for polypoid adenomas, histopathological lesions and cell proliferation. An analysis of all data shows that a LOAEC of 2ppm it is not justified for cell proliferation and polypoid adenomas. Higher values are also supported by a new statistical analysis. For histopathological lesions a NOAEC of 1ppm may be defined but the lesions at 2ppm cannot be regarded as pre-stages for tumour development. One major uncertainty exists: the description of polypoid adenomas and the lesions at 2ppm often is insufficient and diagnostic uncertainties can only be resolved by a re-evaluation according to modern histomorphological standards. Although the discrepancy between our assessment and that of RAC may seem rather small we feel the LOAECs proposed by RAC must be challenged taking into consideration the broad data base for formaldehyde and the potential impact of any published RAC opinion on the present discussions about appropriate occupational and indoor exposure limits.
authors: CinTox, France. Electronic address: heinz-peter.gelbke@gmx.de.
authors: Heinz-Peter
authors: HP
authors: Gelbke
authors: BASF SE, Ludwigshafen, Germany.
authors: Sibylle
authors: S
authors: Gröters
authors: Institute for Occupational Epidemiology and Risk Assessment of Evonik Industries AG, Essen, Germany; Institute and Policlinic for Occupational Medicine, Environmental Medicine and Preventive Research, University of Cologne, Cologne, Germany.
authors: Peter
authors: P
authors: Morfeld
mesh_terms: D000818:Animals; D004781:Environmental Exposure / Q000009:adverse effects*; D004784:Environmental Monitoring / Q000379:methods*; D005557:Formaldehyde / Q000008:administration & dosage / Q000633:toxicity*; D006801:Humans; D019055:No-Observed-Adverse-Effect Level; D016273:Occupational Exposure / Q000009:adverse effects; D018570:Risk Assessment / Q000379:methods
chemical_list: D005557:Formaldehyde
keywords: Cell proliferation; Formaldehyde; Histopathological alterations; LOAEC; Polypoid adenomas; RAC opinion