SAFETY EVALUATION

Isabel Devesa, Enrique Barrajon, Asia Fernandez-Carvajal, Maria Herranz, Guest Lecturers (24 h - 3 ECTS)

Theory: 12 h

Laboratory: 12h

Title Safety Evaluation (3 ECTS)
Program

 

1.    Potential off target effects and toxicological profile. Basic key concepts for the safety evaluation procedure of a cosmetic ingredient. Exposure assessment. Overview of relevant toxicological studies. Chemical specifications risk potential. Microbiology.

Academic lecturer (2 hours): Isabel Devesa

2.   Evaluation of acute toxicity and phototoxicityIn vitro method to determine cytotoxicity and acute toxicity. Validated method to determine the phototoxic potential of a cosmetic ingredient.

Academic lecturer (2 hours): Maria Herranz, Isabel Devesa. Laboratory (9 hours) Isabel Devesa, Maria Herranz, Asia Fernández-Carvajal

3.   Evaluation of irritation, corrosion, and sensitization. Methods to determine reversible (irritation) or irreversible (corrosion) damage of the skin and eye following the application of a test substance or product. Sensitization: capacity of an agent to induced specific immune response after skin contact.

Academic lecturer (2 hours): Isabel Devesa

4.   Genotoxicity, mutagenesis and carcinogenesis risk.  In vitro methods to evaluate mutagenicity and genotoxicity risk of a new cosmetic ingredients. Comet assay, Ames test, and Micronucleous in vitro assays. Carcinogenesis risk evaluation for cosmetics.

Academic lecturer (2 hours): Asia Fernandez-Carvajal

5.   Dermal or percutaneous absorption. Evaluation of dermal permeability or systemic absorption potential upon topical application using cell Franz in vitro methods.

Academic lecturer (2 hours): Enrique Barrajón. Laboratory (3 hours): Enrique Barrajón.

6.   Evaluation risks. In vivo safety evaluation. Skin compatibility, phototoxic potential, hypoallergenity and irritant studies.

Academic lecturer (2 hours): Isabel Devesa.

Sources –  OECD guidelines for testing of Chemicals. Section 4. Health Effects

–  Regulation EC No 1223/2009 of European Parliament for cosmetic products. OF THE

–  Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (2013/674/EU)

–  The SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation 10th revision (2018).

Objectives and expected results Students should be able to know the potential off-target effects relevant to define risk potential in human health for new cosmetic. In addition, students will be able know and understand the mandatory in vitro safety assays required to define the toxicological profiles of new cosmetic ingredient or product.
Prerequisites Basic knowledge of cell biology, pharmacology, pharmacokinetics concepts and cell culture methods.
Teaching methods Theoretical sessions will be based on classic lectures. Discussion between lecturers and students and journal club discussions will be also used to reinforce the main topics.

Practical sessions will be based on team and individual tasks. During these practical sessions, student will be asked to use internet resources and scientific databases to develop their exercises.

Exam modality 30% of the mark. work in small group

30% of the mark. After each practical session, student will prepare the required documentation that will be graded according the given instructions.

40% of the mark. A final written exam evaluating the knowledge and notions acquired during the lectures and practical sessions); the test will consist of up to 4 open questions (answers of 100-150 words maximum) and 10-20 multiple choice questions (with one true answer).

TITLE

Safety Evaluation (3 ECTS)

 

PROGRAM

  1. Potential off target effects and toxicological profile. Basic key concepts for the safety evaluation procedure of a cosmetic ingredient. Exposure assessment. Overview of relevant toxicological studies. Chemical specifications risk potential. Microbiology.

Academic lecturer (2 hours): Isabel Devesa

  1. Evaluation of acute toxicity and phototoxicity. In vitro method to determine cytotoxicity and acute toxicity. Validated method to determine the phototoxic potential of a cosmetic ingredient.

Academic lecturer (2 hours): Maria Herranz, Isabel Devesa. Laboratory (9 hours) Isabel Devesa, Maria Herranz, Asia Fernández-Carvajal

  1. Evaluation of irritation, corrosion, and sensitization. Methods to determine reversible (irritation) or irreversible (corrosion) damage of the skin and eye following the application of a test substance or product. Sensitization: capacity of an agent to induced specific immune response after skin contact.

Academic lecturer (2 hours): Isabel Devesa

  1. Genotoxicity, mutagenesis and carcinogenesis risk. In vitro methods to evaluate mutagenicity and genotoxicity risk of a new cosmetic ingredients. Comet assay, Ames test, and Micronucleous in vitro assays. Carcinogenesis risk evaluation for cosmetics.

Academic lecturer (2 hours): Asia Fernandez-Carvajal

  1. Dermal or percutaneous absorption. Evaluation of dermal permeability or systemic absorption potential upon topical application using cell Franz in vitro methods.

Academic lecturer (2 hours): Enrique Barrajón. Laboratory (3 hours): Enrique Barrajón.

  1. Evaluation risks. In vivo safety evaluation. Skin compatibility, phototoxic potential, hypoallergenity and irritant studies.

Academic lecturer (2 hours): Isabel Devesa.

SOURCES

  • OECD guidelines for testing of Chemicals. Section 4. Health Effects
  • Regulation EC No 1223/2009 of European Parliament for cosmetic products. OF THE
  • Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (2013/674/EU)
  • The SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation 10th revision (2018).

OBJECTIVES AND EXPECTED RESULTS

Students should be able to know the potential off-target effects relevant to define risk potential in human health for new cosmetic. In addition, students will be able know and understand the mandatory in vitro safety assays required to define the toxicological profiles of new cosmetic ingredient or product.

PREREQUISITES

Basic knowledge of cell biology, pharmacology, pharmacokinetics concepts and cell culture methods.

TEACHING METHODS

Theoretical sessions will be based on classic lectures. Discussion between lecturers and students and journal club discussions will be also used to reinforce the main topics.

Practical sessions will be based on team and individual tasks. During these practical sessions, student will be asked to use internet resources and scientific databases to develop their exercises.

EXAM MODALITY

30% of the mark. work in small group.

30% of the mark. After each practical session, student will prepare the required documentation that will be graded according the given instructions.

40% of the mark. A final written exam evaluating the knowledge and notions acquired during the lectures and practical sessions); the test will consist of up to 4 open questions (answers of 100-150 words maximum) and 10-20 multiple choice questions (with one true answer).

Last modified: January 07, 2020