87834 - Cosmetics Toxicology And Efficacy Evaluation

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

The course consists of 40 hours of lectures, devoted to the theoretical and regulatory aspects of toxicology and cosmetic efficacy evaluation, and 15 hours of laboratory sessions, during which students will apply the knowledge acquired by performing in vitro assays, analysing experimental data, and critically discussing the results.

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

Students will perform laboratory activities including:

• mammalian cell culture
• cytotoxicity assays
• phototoxicity assays
• antioxidant activity assays
• analysis and interpretation of experimental data

Readings/Bibliography

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

SCCS Notes of Guidance (latest version)

Regulation (EC) No. 1223/2009 on cosmetic products

OECD Test Guidelines relevant to cosmetic toxicology

EURL ECVAM recommendations

Scientific papers and review articles provided during the course.

Teaching methods

Teaching activities combine lectures with laboratory sessions in order to integrate theoretical knowledge with practical application. Lectures include the discussion of scientific literature, regulatory documents and real case studies concerning cosmetic ingredients and finished products. Laboratory activities allow students to perform in vitro toxicological and efficacy assays, analyse experimental data and critically interpret the obtained results. Active participation during discussions is encouraged to promote critical thinking and scientific reasoning.

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

Student achievement is assessed through an oral examination aimed at evaluating both knowledge acquisition and the ability to critically apply toxicological principles to cosmetic products.

During the examination students will be required to:

• discuss toxicological mechanisms and safety assessment strategies;
• interpret experimental and regulatory information;
• justify the selection of appropriate testing methods;
• critically analyse case studies related to cosmetic safety and efficacy;
• demonstrate the ability to integrate scientific evidence with current European cosmetic legislation.

Particular attention will be given to the use of appropriate scientific terminology and logical reasoning.

Assessment criteria: Excellent (30–30L); Good (27–29); Satisfactory (24–26); Adequate (18–23); Insufficient

The use of Artificial Intelligence (AI) tools during the examination is prohibited in any form. This includes chatbots, text generators, advanced translators, content summarizers, and tools integrated into devices. Any use of AI tools, as well as any use of digital devices of any kind, will be considered a breach of the principles of honesty and fairness set out in the University Policy and will result in the cancellation of the examination and/or disciplinary measures.

Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.

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 Eleonora Turrini