System toxicity and risk assessment

A.A. 2019/2020
Insegnamento per
7
Crediti massimi
64
Ore totali
SSD
BIO/14
Lingua
Inglese
Obiettivi formativi
The aim of the System toxicity and Risk assessment course is to provide the methodology for the analysis and characterization of the hazard and the consequent risk assessment deriving from exposure to xenobiotics and biotechnological products.
Therefore, the course deals the scientific background that allow the establishment, through the risk assessment, of Health Based Guidance Values for chemicals in various field, including food, cosmetics, drugs, occupational environments.
In the meantime, it provides useful indications for sustainable development, in term of reduction of the toxic impact of chemicals with the environment and with human health.

Struttura insegnamento e programma

Edizione attiva
Responsabile
Moduli o unità didattiche
Risk Assessment
BIO/14 - FARMACOLOGIA - CFU: 4
: 16 ore
Lectures: 24 ore

System Toxicity
BIO/14 - FARMACOLOGIA - CFU: 3
Lectures: 24 ore

Prerequisiti e modalità di esame
The course requires knowledge of biology, physiology, chemistry and toxicology. The examination generally consists of an approx. 30 minutes oral examination, with open question and the discussion of a case-study covering one of the topics of the course.
Risk Assessment
Materiale didattico e bibliografia
Contribution of toxicology towards risk assessment of carcinogens.
Kroes R. Arch Toxicol. 1987;60(1-3):224-8.

Chemically induced proliferation of peroxisomes: implications for risk assessment.
Stott WT. Regul Toxicol Pharmacol. 1988 Jun;8(2):125-59.

Workshop on risk assessment in reproductive and developmental toxicology: addressing the assumptions and identifying the research needs.
Sheehan DM, Young JF, Slikker W Jr, Gaylor DW, Mattison DR.
Regul Toxicol Pharmacol. 1989 Oct;10(2):110-22.

Uncertainties in the risk assessment of three mycotoxins: aflatoxin, ochratoxin, and zearalenone.
Kuiper-Goodman T. Can J Physiol Pharmacol. 1990 Jul;68(7):1017-24.

Biologically based pharmacodynamic models: tools for toxicological research and risk assessment.
Conolly RB, Andersen ME. Annu Rev Pharmacol Toxicol. 1991;31:503-23.

A weight-of-evidence approach for assessing interactions in chemical mixtures.
Mumtaz MM, Durkin PR. Toxicol Ind Health. 1992 Nov-Dec;8(6):377-406.

Molecular epidemiology in cancer risk assessment and prevention: recent progress and avenues for future research.
Wogan GN. Environ Health Perspect. 1992 Nov;98:167-78.

Risk assessment of d-limonene: an example of male rat-specific renal tumorigens.
Hard GC, Whysner J. Crit Rev Toxicol. 1994;24(3):231-54.

Food Chem Toxicol. 2017 May;103:188-193. doi: 10.1016/j.fct.2017.03.012. Epub 2017 Mar 7.
Human exposure to chemical mixtures: Challenges for the integration of toxicology with epidemiology data in risk assessment. Hernández AF, Tsatsakis AM.

Environ Int. 2017 Feb;99:97-106. doi: 10.1016/j.envint.2016.11.029. Epub 2016 Dec 8. From the exposome to mechanistic understanding of chemical-induced adverse effects. Escher B et al.

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

Metabolic activation and drug-induced liver injury: in vitro approaches for the safety risk assessment of new drugs. Gómez-Lechón MJ, Tolosa L, Donato MT.
J Appl Toxicol. 2016 Jun;36(6):752-68. doi: 10.1002/jat.3277. Epub 2015 Dec 22.

Considering new methodologies in strategies for safety assessment of foods and food ingredients.
Blaauboer BJ, Boobis AR, Bradford B, Cockburn A, Constable A, Daneshian M, Edwards G, Garthoff JA, Jeffery B, Krul C, Schuermans J.
Food Chem Toxicol. 2016 May;91:19-35. doi: 10.1016/j.fct.2016.02.019. Epub 2016 Mar 3.

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.

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.

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 of dietary supplements.
Boobis AR. Novartis Found Symp. 2007;282:3-25; discussion 25-8, 212-8.

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.

Metals in cosmetics: an a posteriori safety evaluation. Marinovich M, Boraso MS, Testai E, Galli CL.
Regul Toxicol Pharmacol. 2014 Aug;69(3):416-24.

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.

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.

Is the acceptable daily intake as presently used an axiom or a dogma? Galli CL, Marinovich M, Lotti M.
Toxicol Lett. 2008 Aug 15;180(2):93-9. doi: 10.1016/j.toxlet.2008.06.003. Epub 2008 Jun 8.

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.

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.

Judgments of chemical risks: comparisons among senior managers, toxicologists, and the public.
Mertz CK, Slovic P, Purchase IF. Risk Anal. 1998 Aug;18(4):391-404.

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.

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.
System Toxicity
Materiale didattico e bibliografia
Contribution of toxicology towards risk assessment of carcinogens.
Kroes R. Arch Toxicol. 1987;60(1-3):224-8.

Chemically induced proliferation of peroxisomes: implications for risk assessment.
Stott WT. Regul Toxicol Pharmacol. 1988 Jun;8(2):125-59.

Workshop on risk assessment in reproductive and developmental toxicology: addressing the assumptions and identifying the research needs.
Sheehan DM, Young JF, Slikker W Jr, Gaylor DW, Mattison DR.
Regul Toxicol Pharmacol. 1989 Oct;10(2):110-22.

Uncertainties in the risk assessment of three mycotoxins: aflatoxin, ochratoxin, and zearalenone.
Kuiper-Goodman T. Can J Physiol Pharmacol. 1990 Jul;68(7):1017-24.

Biologically based pharmacodynamic models: tools for toxicological research and risk assessment.
Conolly RB, Andersen ME. Annu Rev Pharmacol Toxicol. 1991;31:503-23.

A weight-of-evidence approach for assessing interactions in chemical mixtures.
Mumtaz MM, Durkin PR. Toxicol Ind Health. 1992 Nov-Dec;8(6):377-406.

Molecular epidemiology in cancer risk assessment and prevention: recent progress and avenues for future research.
Wogan GN. Environ Health Perspect. 1992 Nov;98:167-78.

Risk assessment of d-limonene: an example of male rat-specific renal tumorigens.
Hard GC, Whysner J. Crit Rev Toxicol. 1994;24(3):231-54.

Food Chem Toxicol. 2017 May;103:188-193. doi: 10.1016/j.fct.2017.03.012. Epub 2017 Mar 7.
Human exposure to chemical mixtures: Challenges for the integration of toxicology with epidemiology data in risk assessment. Hernández AF, Tsatsakis AM.

Environ Int. 2017 Feb;99:97-106. doi: 10.1016/j.envint.2016.11.029. Epub 2016 Dec 8. From the exposome to mechanistic understanding of chemical-induced adverse effects. Escher B et al.

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

Metabolic activation and drug-induced liver injury: in vitro approaches for the safety risk assessment of new drugs. Gómez-Lechón MJ, Tolosa L, Donato MT.
J Appl Toxicol. 2016 Jun;36(6):752-68. doi: 10.1002/jat.3277. Epub 2015 Dec 22.

Considering new methodologies in strategies for safety assessment of foods and food ingredients.
Blaauboer BJ, Boobis AR, Bradford B, Cockburn A, Constable A, Daneshian M, Edwards G, Garthoff JA, Jeffery B, Krul C, Schuermans J.
Food Chem Toxicol. 2016 May;91:19-35. doi: 10.1016/j.fct.2016.02.019. Epub 2016 Mar 3.

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.

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.

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 of dietary supplements.
Boobis AR. Novartis Found Symp. 2007;282:3-25; discussion 25-8, 212-8.

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.

Metals in cosmetics: an a posteriori safety evaluation. Marinovich M, Boraso MS, Testai E, Galli CL.
Regul Toxicol Pharmacol. 2014 Aug;69(3):416-24.

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.

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.

Is the acceptable daily intake as presently used an axiom or a dogma? Galli CL, Marinovich M, Lotti M.
Toxicol Lett. 2008 Aug 15;180(2):93-9. doi: 10.1016/j.toxlet.2008.06.003. Epub 2008 Jun 8.

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.

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.

Judgments of chemical risks: comparisons among senior managers, toxicologists, and the public.
Mertz CK, Slovic P, Purchase IF. Risk Anal. 1998 Aug;18(4):391-404.

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.

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.
Periodo
Primo semestre
Periodo
Primo semestre
Modalità di valutazione
Esame
Giudizio di valutazione
voto verbalizzato in trentesimi
Docente/i
Ricevimento:
Previo appuntamento telefonico
Via Balzaretti 9
Ricevimento:
Previo appuntamento telefonico
Dip. scienze farmacologiche - via Balzaretti 9