System toxicity and risk assessment

GUIDELINES
Hazard identification by methods of animal-based toxicology. Barlow SM, Greig JB, Bridges JW, Carere A, Carpy AJ, Galli CL, Kleiner J, Knudsen I, Koëter HB, Levy LS, Madsen C, Mayer S, Narbonne JF, Pfannkuch F, Prodanchuk MG, Smith MR, Steinberg P. Food Chem Toxicol. 2002 Feb-Mar;40(2-3):145-91.

Update: Guidance on the use of the benchmark dose approach in risk assessment. EFSA Scientific Committee, Hardy A, Benford D, Halldorsson T, Jeger MJ,Knutsen KH, More S, Mortensen A, Naegeli H, Noteborn H, Ockleford C, Ricci A, Rychen G, Silano V, Solecki R, Turck D, Aerts M, Bodin L, Davis A, Edler L, Gundert-Remy U, Sand S, Slob W, Bottex B, Abrahantes JC, Marques DC, Kass G and Schlatter JR, 2017.
EFSA Journal 2017;15(1):4658, 41 pp. doi:10.2903/j.efsa.2017.4658

Scientific Opinion on the guidance on the use of the weight of evidence approach in scientific
assessments. EFSA Scientific Committee, Hardy A, Benford D, Halldorsson T, Jeger MJ,
Knutsen HK, More S, Naegeli H, Noteborn H, Ockleford C, Ricci A, Rychen G, Schlatter JR, Silano V,
Solecki R, Turck D, Benfenati E, Chaudhry QM, Craig P, Frampton G, Greiner M, Hart A, Hogstrand C,
Lambre C, Luttik R, Makowski D, Siani A, Wahlstroem H, Aguilera J, Dorne J-L, Fernandez Dumont A,
Hempen M, Valtue~na Mart ınez S, Martino L, Smeraldi C, Terron A, Georgiadis N and Younes M, 2017.
EFSA Journal 2017;15(8):4971, 69 pp. https://doi.org/10.2903/j.efsa.2017.4971

EMA/CHMP/ CVMP/ SWP/169430/2012 Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP), Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, 20 November 2014

7199/VI/99 rev. 5 05/07/2001 Draft Guidance Document GUIDANCE FOR THE SETTING OF AN ACUTE REFERENCE DOSE (ARfD)

International Programme on Chemical Safety & IPCS Workshop on Incorporating Uncertainty and Variability into Risk Assessment (‎‎2000 : Berlin, Germany)‎‎. (‎2005)‎. Chemical-specific adjustment factors for interspecies differences and human variability : guidance document for use of data in dose/concentration-response assessment. World Health Organization. https://apps.who.int/iris/handle/10665/43294

TR 085 - Recognition of, and Differentiation between, Adverse and Non-adverse Effects in Toxicology Studies
29 December 2002

TR 110 : Guidance on Assessment Factors to Derive a DNEL | Dec 2010 Executive Summary The European Regulation on the Registration, Evaluation, Authorisation

CHMP/ICH/83812/2013 Committee for Human Medicinal ProductsICH guideline M7(R1)on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, 25 August 2015EMA


OPEN LITERATURE
Virunya S. Bhat, M.E. (Bette) Meek, Mathieu Valcke, Caroline English, Alan Boobis & Richard Brown (2017) Evolution of chemical-specific adjustment factors (CSAF) based on recent international experience; increasing utility and facilitating regulatory acceptance, Critical Reviews in Toxicology, 47:9, 733-753, DOI: 10.1080/10408444.2017.1303818

Is it adverse, non-adverse, adaptive or artifact?
Arun R. Pandiri, Roy L. Kerlin, Peter C. Mann, Nancy E. Everds4, Alok K. Sharma, L. Peyton Myers, and Thomas J. Steinbach
Toxicol Pathol. 2017 January ; 45(1): 238-247. doi:10.1177/0192623316672352

Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.
Buchholzer ML, Werner C, Knoess W.
Regul Toxicol Pharmacol. 2014 Mar;68(2):193-200. doi: 10.1016/j.yrtph.2013.12.008. Epub 2013 Dec 30.

What determines the acceptability of genetically modified food that can improve human nutrition?
Purchase IF. Toxicol Appl Pharmacol. 2005 Sep 1;207(2 Suppl):19-27.

Scientific analysis of the proposed uses of the T25 dose descriptor in chemical carcinogen regulation.
Roberts RA, Crump KS, Lutz WK, Wiegand HJ, Williams GM, Harrison PT, Purchase IF.
Arch Toxicol. 2001 Nov;75(9):507-12.

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.
Speijers G, Bottex B, Dusemund B, Lugasi A, Tóth J, Amberg-Müller J, Galli CL, Silano V, Rietjens IM.
Mol Nutr Food Res. 2010 Feb;54(2):175-85. doi: 10.1002/mnfr.200900240.

Application of the TTC concept to unknown substances found in analysis of foods.
Koster S, Boobis AR, Cubberley R, Hollnagel HM, Richling E, Wildemann T, Würtzen G, Galli CL.
Food Chem Toxicol. 2011 Aug;49(8):1643-60. doi: 10.1016/j.fct.2011.03.049. Epub 2011 Mar 30

A tiered approach to systemic toxicity testing for agricultural chemical safety assessment.
Doe JE, et al. Crit Rev Toxicol. 2006 Jan;36(1):37-68.

A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens.
Felter SP et al.
Crit Rev Toxicol. 2011 Jul;41(6):507-44. doi: 10.3109/10408444.2011.552063. Epub 2011 May 18

Risk assessment in the 21st century: roadmap and matrix.
Embry MR et al. Crit Rev Toxicol. 2014 Aug;44 Suppl 3:6-16. doi: 10.3109/10408444.2014.931924.

The use of mode of action information in risk assessment: quantitative key events/dose-response framework for modeling the dose-response for key events.
Simon TW et al. Crit Rev Toxicol. 2014 Aug;44 Suppl 3:17-43. doi: 10.3109/10408444.2014.931925.

Regulatory assessment of chemical mixtures: Requirements, current approaches and future perspectives.
Kienzler A, Bopp SK, van der Linden S, Berggren E, Worth A.
Regul Toxicol Pharmacol. 2016 Oct;80:321-34. doi: 10.1016/j.yrtph.2016.05.020. Epub 2016 May 20