03033 - Toxicology

Learning outcomes

At the end of the course the student knows :

- the effect of toxic chemical agents, drugs and food additives in living organisms, placing in the spotlight the basics of toxicology, causes and symptoms of toxicity,

- the mechanisms of toxic action at the cellular and molecular level,

- the drug discovery and the drug preclinic development process,

- the procedures for risk evaluation,

- how to identify the hazards associated with pharmaceutical products and minimise the risk of any harm that may come to patients ,

- the toxicological prerequisites for evaluating new drugs and to demonstrate the harmful effects of toxic agents in general and of environmental toxins,

- the toxic effects of contaminants in food and in the environment.

Course contents

MODULE "TOXICOLOGY " (Prof. Patrizia Hrelia)

General Toxicology. Principles of Toxicology, spectrum of undesired effects; mechanisms of toxicity; dose- response curve. Absorption, distribution, and excretion of toxicants; biotransformation of xenobiotics. Toxicogenetic and toxicogenomic. Gender differences in toxicology. Toxic effects in children.

Molecular and cellular aspects of Toxicology. Cell death. Genetic toxicology. Chemical carcinogenesis. Developmental toxicology. Teratogens.

Target organ toxicity .Toxic responses of the liver. Toxic responses of the kidney. Toxic responses of the respiratory system. Toxic responses of the central nervous system. Toxic responses of the heart and vascular system. Toxic responses of the reproductive system. Toxic responses of the immune system. Toxic responses of the skin.

Special toxicology. The process of drug development and regulatory aspects. Safety of new chemical entities and biotech medicines. Risk assessment and risk/benefit evaluation. Chemoprevention of chronic degenerative diseases. Safety of food supplements. Safety of cosmetic products.

Environmental anf food toxicology. Food safety.  Natural toxins. Pesticides, food additives and residues.Toxic compounds from technologic processes. Heavy metals. Peristant organic pollutants. Molecular epidemiology.

MODULE "APPLIED TOXICOLOGY " (Prof. Fabiana Morroni)

Safety regulatory requirements in the development of health products.

Experimental methods in Toxicology. Organization of a Toxicology laboratory; Good Laboratory Practices (GLP); Standard Operating Procedures (SOP).

In vitro studies. Cell cultures and cytotoxicity tests. Alternative methodologies to the use of animals in Toxicology: development, validation and application to the screening and characterization of organ toxicity.

In vivo studies. General principles, predictivity and selection of doses; aims of the studies. Acute toxicity studies: aims, lethality curves, limit of acute exposure; methods: experimental design, analyses and observations. Repeated dose toxicity tests versus acute toxicity studies, analyses and observations.

Methods for the study of carcinogenic and genotoxic potential. Types of studies for the evaluation of carcinogenicity. Long-term carcinogenity studies. Short-term genetic toxicology studies. Mutagenicity tests: principles; Ames test; mammalian culture tests; test with transgenic animals. Chromosome aberration test; micronucleus test. Methods for aneuploidy detection.

Methods for the study of local tolerance.

Methods for the study of reprotoxic potential: multigenerational studies, fertility studies, teratogenic potential, peri- and post-natal toxicity.

Readings/Bibliography

Lecture files and the notes taken in class are essential for the preparation of the exam.

Students may refer to:

Casarett & Doull - Elementi di Tossicologia ( a cura di Hrelia P e Cantelli Forti G), Casa Editrice Ambrosiana, Milano, 2013.

Balduini W e Costa L.G. Tossicologia generale e applicata ai farmaci. Edra Ed, 2015.

Casarett & Doull's - Tossicologia - I fondamenti dell'azione delle sostanze tossiche (traduzione italiana della VII edizione), EMSI, Roma, 2010.

Lecture files are available at University of Bologna site https://iol.unibo.it [https://iol.unibo.it/]

Teaching methods

Lectures and seminars.

Attendance at the course is mandatory for 60% of class hours.

Assessment methods

The exam will consist in an oral test aimed at assessing the student's understanding and knowledge of the topics set out during the course. The examination consists of an interview focusing on three modules which can not be split and must therefore be dealt with within one exam. The marks obtained for each interview, in proportion to the number of credits, contribute to the final grade of thirty. The achievement by the student of an organic vision of the issues addressed during the course and the use of an appropriate specific terminology will be assessed with a mark of excellence.

At the end of the course it can be set up a "one-off" written tests (or an oral evaluation depending on COVID emergency) on Applied Toxicology, that if overcome with positive vote will count as the acquisition of knowledge for the final exam.

Teaching tools

PC, websites.

The lecture files are available at https://iol.unibo.it [https://iol.unibo.it/]

Office hours

See the website of Patrizia Hrelia

See the website of Fabiana Morroni