title: Incorporating potency into EU classification for carcinogenicity and reproductive toxicity.
abstract: Although risk assessment, assessing the potential harm of each particular exposure of a substance, is desirable, it is not feasible in many situations. Risk assessment uses a process of hazard identification, hazard characterisation, and exposure assessment as its components. In the absence of risk assessment, the purpose of classification is to give broad guidance (through the label) on the suitability of a chemical in a range of use situations. Hazard classification in the EU is a process involving identification of the hazards of a substance, followed by comparison of those hazards (including degree of hazard) with defined criteria. Classification should therefore give guidance on degree of hazard as well as hazard identification. Potency is the most important indicator of degree of hazard and should therefore be included in classification. This is done for acute lethality and general toxicity by classifying on dose required to cause the effect. The classification in the EU for carcinogenicity and reproductive toxicity does not discriminate across the wide range of potencies seen (6 orders of magnitude) for carcinogenicity and for developmental toxicity and fertility. Therefore potency should be included in the classification process. The methodology in the EU guidelines for classification for deriving specific concentration limits is a rigorous process for assigning substances which cause tumours or developmental toxicity and infertility in experimental animals to high, medium or low degree of hazard categories by incorporating potency. Methods are suggested on how the degree of hazard so derived could be used in the EU classification process to improve hazard communication and in downstream risk management.
authors.affiliation: ECETOC AISBL, Avenue E. van Nieuwenhuyse 2 Bte 8, Brussels B-1160, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Hennes
authors.affiliation: Fraunhofer Institute for Toxicology & Experimental Medicine, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany. Electronic address: monika.batke@item.fraunhofer.de.
authors.forename: M
authors.initials: M
authors.lastname: Batke
authors.affiliation: Bayer CropScience AG, Alfred-Nobel-Straße 50, D-40789 Monheim/Rhein, Germany. Electronic address: info@tox-consult.com.
authors.forename: W
authors.initials: W
authors.lastname: Bomann
authors.affiliation: Total Research and Technology Feluy, Zone Industrielle Feluy C, 7181 Seneffe, Belgium. Electronic address: sophie.duhayon@total.com.
authors.forename: S
authors.initials: S
authors.lastname: Duhayon
authors.affiliation: Procter & Gamble Service GmbH, Berliner Allee 65, 64295 Darmstadt, Germany. Electronic address: kosemund.k@pg.com.
authors.forename: K
authors.initials: K
authors.lastname: Kosemund
authors.affiliation: Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA. Electronic address: vpolitano@rifm.org.
authors.forename: V
authors.initials: V
authors.lastname: Politano
authors.affiliation: Product Safety, Regulations, Toxicology and Ecology, BASF SE, GUP/PP - Z470, 67056 Ludwigshafen, Germany. Electronic address: stefan.stinchcombe@basf.com.
authors.forename: S
authors.initials: S
authors.lastname: Stinchcombe
authors.affiliation: Parker Doe Partnership LLP, PO Box 139, Frodsham, Cheshire WA6 1AZ, United Kingdom. Electronic address: john.doe@parkerdoe.com.
authors.forename: J
authors.initials: J
authors.lastname: Doe
mesh_terms: D000818:Animals; D063646:Carcinogenesis / Q000187:drug effects*; D005062:European Union; D005298:Fertility / Q000187:drug effects; D015386:Hazardous Substances / Q000009:adverse effects*; D006801:Humans; D012098:Reproduction / Q000187:drug effects*; D018570:Risk Assessment; D012308:Risk Management / Q000379:methods; D017751:Safety Management / Q000379:methods
chemical_list: D015386:Hazardous Substances
keywords: Carcinogenicity; Classification; Degree of hazard; Developmental toxicity; Hazard communication; Potency; Reproductive toxicity