Incorporating potency into EU classification for carcinogenicity and reproductive toxicity

التفاصيل البيبلوغرافية
العنوان: Incorporating potency into EU classification for carcinogenicity and reproductive toxicity
المؤلفون: Valerie T. Politano, J. Doe, S. Duhayon, S. Stinchcombe, Monika Batke, Werner Bomann, K. Kosemund, C. Hennes
المساهمون: Publica
المصدر: Regulatory Toxicology and Pharmacology. 70(2):457-467
بيانات النشر: Elsevier BV, 2014.
سنة النشر: 2014
مصطلحات موضوعية: Safety Management, Reproductive toxicity, Carcinogenesis, Developmental toxicity, Hazard analysis, Toxicology, Risk Assessment, Hazardous Substances, Environmental health, Medicine, Animals, Humans, European Union, Risk management, Exposure assessment, Risk Management, Carcinogenicity, business.industry, Reproduction, General Medicine, Potency, Classification, Hazard, Hazard communication, Fertility, Lethality, business, Risk assessment, Degree of hazard
الوصف: 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.
تدمد: 0273-2300
DOI: 10.1016/j.yrtph.2014.07.022
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eaf2b2622f389af0c0d1c8314f693191
Rights: OPEN
رقم الانضمام: edsair.doi.dedup.....eaf2b2622f389af0c0d1c8314f693191
قاعدة البيانات: OpenAIRE
الوصف
تدمد:02732300
DOI:10.1016/j.yrtph.2014.07.022