Toxicology and risk assessment
A.A. 2023/2024
Obiettivi formativi
The course is aimed at providing the specific knowledge about toxicology and risk assessment applied to the cosmetic field. The course will highlight the principles of cellular toxicity about skin, skin annexes and eye toxicology in terms of irritation, allergies, hypersensitivity, also related to daily exposure. Potential harmful effects of both natural and synthetic chemical compounds, used in the skincare formulations, make-up, and cleaning products will be analysed. Furthermore, the course will describe the tests used to evaluate the toxicity of cosmetics ingredient and the process of cosmetics risk assessment, divided in three steps: the hazard identification, the dose-response, and the exposure assessment.
Risultati apprendimento attesi
At the end of the course the students will be able to:
- Describe with proper terminology the mechanisms of cell toxicity potentially induced by cosmetics;
- Describe the ingredients in cosmetics associated to their potentially toxic profile;
- Identify the most appropriate tests to be used to evaluate skin and eye toxicity;
- Describe the process of safety assessment process of cosmetic ingredients;
- Perform basic assays to evaluate cell toxicity and to interpret the results;
- Evaluate and analyse the risk assessment case studies.
- Describe with proper terminology the mechanisms of cell toxicity potentially induced by cosmetics;
- Describe the ingredients in cosmetics associated to their potentially toxic profile;
- Identify the most appropriate tests to be used to evaluate skin and eye toxicity;
- Describe the process of safety assessment process of cosmetic ingredients;
- Perform basic assays to evaluate cell toxicity and to interpret the results;
- Evaluate and analyse the risk assessment case studies.
Periodo: Secondo semestre
Corso singolo
Questo insegnamento può essere seguito come corso singolo.
Programma e organizzazione didattica
Edizione unica
Responsabile
Periodo
Secondo semestre
Programma
Module 1: Toxicology
- Introduction to skin and eye toxicology: fundamentals of dose and exposure
- Skin toxicokinetics: dermal and percutaneous absorption, distribution, metabolism, and excretion
- Skin toxicodynamics: local and systemic toxicity; chronic exposure and repeated-dose toxicity; mechanisms of cell toxicity; classification of toxic effects; irritation, corrosivity, skin sensitisation, genotoxicity, carcinogenicity, photo-induced toxicity; systemic toxicity, reproductive toxicity, and endocrine interference; toxicity in relation to age and skin features
- Toxicity of the main cosmetics ingredients, impurities, natural extracts
- In vitro, ex vivo, and in vivo assays required for safety evaluation and toxicological profile of cosmetic ingredients and finished products; alternative tests and new methodologies; tests on human volunteers.
Module 2: Risk assessment
- Current national and international regulations on cosmetics;
- Product information file (PIF): the product safety report;
- Safety assessment process: Hazard identification (NOAEL), Calculation of the exposure (SED), Risk characterization (MoS);
- Integrated Approaches to Testing and Assessment (IATA);
- CMR substances (carcinogenic, mutagenic or toxic for reproduction) and cosmetic regulations.
- Introduction to skin and eye toxicology: fundamentals of dose and exposure
- Skin toxicokinetics: dermal and percutaneous absorption, distribution, metabolism, and excretion
- Skin toxicodynamics: local and systemic toxicity; chronic exposure and repeated-dose toxicity; mechanisms of cell toxicity; classification of toxic effects; irritation, corrosivity, skin sensitisation, genotoxicity, carcinogenicity, photo-induced toxicity; systemic toxicity, reproductive toxicity, and endocrine interference; toxicity in relation to age and skin features
- Toxicity of the main cosmetics ingredients, impurities, natural extracts
- In vitro, ex vivo, and in vivo assays required for safety evaluation and toxicological profile of cosmetic ingredients and finished products; alternative tests and new methodologies; tests on human volunteers.
Module 2: Risk assessment
- Current national and international regulations on cosmetics;
- Product information file (PIF): the product safety report;
- Safety assessment process: Hazard identification (NOAEL), Calculation of the exposure (SED), Risk characterization (MoS);
- Integrated Approaches to Testing and Assessment (IATA);
- CMR substances (carcinogenic, mutagenic or toxic for reproduction) and cosmetic regulations.
Prerequisiti
None
Metodi didattici
Frontal classes with slides and video support for both modules. Laboratory experiences based on in vitro toxicity assays will be performed in the Toxicology module. In the Risk assessment module, the students will discuss case-studies.
Materiale di riferimento
Slides presented during the classes, digital supplemental material, scientific papers (available on the ARIEL website).
For both Toxicology and Risk assessment, the recommended textbooks are the following:
- Principles and practice of skin toxicology. Chilcott and Price. Wiley, 2018.
- Casarett & Doull's Essential of Toxicology (by Curtis D. Klaassen, John B. III Watkins), Mc Graw-Hill, 2015.
For both Toxicology and Risk assessment, the recommended textbooks are the following:
- Principles and practice of skin toxicology. Chilcott and Price. Wiley, 2018.
- Casarett & Doull's Essential of Toxicology (by Curtis D. Klaassen, John B. III Watkins), Mc Graw-Hill, 2015.
Modalità di verifica dell’apprendimento e criteri di valutazione
Toxicology module: Discussion will take place during the classes. The exam consists in a multiple-choice test with 30 questions: 1 point for every correct answer, -0.5 points for wrong answers, 0 points for unanswered questions. The exam is passed with a minimal score of 18. A written report of the laboratory experience will be evaluated.
Safety assessment module: written report.
The final grade is the average of the grades obtained in the two modules.
Safety assessment module: written report.
The final grade is the average of the grades obtained in the two modules.
BIO/14 - FARMACOLOGIA - CFU: 6
Esercitazioni di laboratorio a posto singolo: 32 ore
Lezioni: 32 ore
Lezioni: 32 ore
Docenti:
Galbiati Valentina, Rzemieniec Joanna
Siti didattici
Docente/i