87834 - Cosmetics Toxicology And Efficacy Evaluation

Academic Year 2023/2024

  • Docente: Lucia Carboni
  • Credits: 6
  • SSD: BIO/14
  • Language: English
  • Moduli: Lucia Carboni (Modulo 1) Giulia Greco (Modulo 2)
  • Teaching Mode: Traditional lectures (Modulo 1) Traditional lectures (Modulo 2)
  • Campus: Rimini
  • Corso: Second cycle degree programme (LM) in Advanced Cosmetic Sciences (cod. 9225)

Learning outcomes

Because of the frequency and after passing the final exam of the course “Cosmetics toxicology and efficacy evaluation”, the student: - knows the main toxicological issues posed by cosmetic products; - has acquired the knowledge on the mechanisms involved in the toxicity of a cosmetic product at skin level; - has acquired the knowledge on the modulation of toxicity/efficacy at skin level by solar radiations; - knows the problems associated with the toxicological risk arising from the use of cosmetic products; - has acquired the basic principles for the toxicological and efficacy evaluation of cosmetic products including the application of alternative methods and the interpretation of the results; - can compile a Product Information File (PIF).

Course contents

Principles of toxicology: definitions, aims and perspectives

Toxicokinetics: absorption, distribution, metabolism and excretion

Skin organization and function and its toxic response, classification of toxic effects and mechanisms of toxicity; phototoxicity

Regulation (EC) N° 1223/2009 and Product information file (PIF)

Tests required for safety evaluation and toxicological profile of cosmetic ingredients:

Acute toxicity, local toxicity, irritation/corrosivity, mucous membrane irritation, eye irritation, skin sensitisation, dermal/percutaneous absorption, repeated dose toxicity, reproductive toxicity, genotoxicity/mutagenicity, carcinogenicity, toxicokinetics studies, photo-induced toxicity

Alternative methodologies to the use of animals in Toxicology: European Union Reference Laboratory for alternatives to animal testing - EURL ECVAM.

Example of in vitro assay: TER, DEREK; Episkin; Epiderm; Epiocular; MTT; neutral red uptake toxicity test; comet assay

Cosmetics risk assessment and margin of safety

Laboratory training

Cell cultures: maintenance and use. Cell count and analysis of cell viability. Evaluation of the cytotoxicity, phototoxicity, genotoxicity, mutagenicity. Neutral red uptake toxicity test, 3-(4,5)-dimethyl-2-thiazolyl-2,5-dimethyl-2Htetrazolium bromide test. Genotoxicity tests at different endpoints. Antioxidant activity by DPPH assay.


Casarett & Doull’s Essential of Toxicology (by Curtis D. Klaassen, John B. III Watkins), Mc Graw-Hill, 2015

Teaching methods

The teaching of the course offers lectures and laboratory training.

As concerns the teaching methods of this course unit, all students must attend Module 1, 2 [https://www.unibo.it/en/services-and-opportunities/health-and-assistance/health-and-safety/online-course-on-health-and-safety-in-study-and-internship-areas] online, while Module 3 on health and safety is to be attended in class or on Microsoft Teams according to the modality chosen by the teacher. Information about Module 3 attendance schedule is available on the website of your degree programme.

Assessment methods

The exam will consist in an oral interview aimed at assessing the students’ understanding and knowledge on the topics set out during the course.

Teaching tools

Overhead projector, PC, blackboard. Slides used during the course will be uploaded at the website https://virtuale.unibo.it/, reserved to students enrolled at this course.

Office hours

See the website of Lucia Carboni

See the website of Giulia Greco


Good health and well-being

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.