Cosmetic Safety Assessment Quiz

Introduction to Cosmetics Safety and Animal Testing Alternatives

• The presentation discusses the safety assessment of cosmetics and alternatives to animal testing.
• Alternatives to animal testing are promoted to reduce animal cruelty.
• The presenter is Professor Danka Tamburic from the London College of Fashion, UK.

Outline of the Presentation

• Refresher:
  • Safety assessment (Annex I of Cosmetics Regulation)
  • Animal testing ban
  • Principles of toxicology
  • Toxicological data sources
• New Material:
  • Alternatives to animal testing (AATs) or New approach methodologies (NAMs)
  • Regulatory-accepted alternatives (summary)
  • Examples
  • Useful references

Annex I: Cosmetic Product Safety Report

• Part A – Cosmetic Product Safety Information:
  • Quantitative and qualitative composition of the cosmetic product
  • Physical/chemical characteristics and stability of the cosmetic product
  • Microbiological quality
  • Impurities, traces, information about packaging material
  • Normal and reasonably foreseeable use
  • Exposure to the cosmetic product
  • Toxicological profile of the substances
  • Undesirable effects and serious undesirable effects
  • Information on the cosmetic product
• Part B – Cosmetic Product Safety Assessment:
  • Assessment conclusion
  • Labelled warnings and instructions of use
  • Reasoning
  • Assessor's credentials and approval of Part B
  • Toxicological profiles are obtained by analyzing data from various sources.

Ban on Animal Testing

• Aim: Phasing out animal testing for finished and ingredient cosmetics products.
• Started by: Cosmetic Directive, now included in Cosmetics regulation.
• Types:
  • Testing Ban (2004-2009): Applies to finished products since 2004, ingredients since 2009.
  • Marketing Ban (2009): Applies to all human effects, excluding repeated-dose toxicity, reproductive toxicity and toxicokinetics.
  • Alternative methods are to be adopted when validated by EU legislation.
  • A 10-year cut-off deadline has passed.

What is Toxicology?

• Toxicology is the study of how chemicals interact with biological systems to cause harm.
• It aims to quantify the potential for chemicals to produce injury.
• Xenobiotics: Chemicals foreign to the body.
• Poisons/toxins: Substances causing harm or injury.
• Toxicity: The degree to which a substance is poisonous or harmful.
• Toxicity depends on dose, duration of exposure, route of exposure, chemical type, and individual factors. The dose is the amount of exposure to the substance (e.g., 5 mg/kg/day). Almost all substances are toxic under the right conditions.
• Toxic effects: Health consequences of exposure to a toxic substance, can be local or systemic, acute or chronic, and reversible or irreversible.

Hazard and Risk

• Hazard is the potential to cause harm, intrinsic to the material.
• Risk is the probability of harm, directly related to exposure and exposure changes the severity and nature of harm.
• Risk= Hazard x Exposure

How do we Assess Risk?

• To assess risk, one must know the hazard and estimate human exposure.
• Risk assessment is an objective quantification of the probabilities and consequences of adverse effects.
• Absolute safety does not exist, however, the "safe dose" is the best achievable.

How do we Assess Hazard?

• Toxicological profile is essential for assessing hazard.
• NOAEL: No Observable Adverse Effect Level - the highest dose with no observable effects.
• LD50: Dose at which half of the tested population dies.

How do we Assess the Margin of Safety?

• NOAEL: Determined by animal studies, alternative approaches are gaining validity.
• Systemic Exposure Dose(SED): Determined from percutaneous penetration studies.
• Margin of Safety (MOS) = NOAEL/SED; a high MOS is required for cosmetic use.

Toxicological Endpoints

• Examples include acute toxicity, skin irritation, skin corrosion, eye irritation, skin sensitization, repeated dose toxicity, chronic toxicity, reproductive toxicity, toxicokinetics, mutagenicity, and carcinogenicity.

Animal Testing

• Disregarding animal cruelty is important.
• Animal testing is not ideal as humans are not ideal substitutes.
• Equivalent applied dose does not always equal equivalent effect.
• Animals often react differently to chemicals than humans.

Alternatives to Animal Testing (AATs)

• AATs replace, refine, or reduce animal use in testing.
• The EU's 3R strategy (Reduction, Refinement, and Replacement).
• AAT methods are often called NAMs (New Approach Methodologies).

EURL ECVAM (EU Reference Laboratory for Alternatives to Animal Testing)

• EURL ECVAM promotes and facilitates non-animal testing methods.
• It is an independent scientific body.

Problems Facing the Industry

• Despite investment, progress in developing AATs is slow, in part, due to:
  • Complexity of the task (limited non-animal models, integration difficulties)
  • Difficulty linking in vitro to in vivo data.
  • EU industry limitations in introducing new ingredients and applying existing ingredients to new uses.
  • Respond to new safety questions on existing ingredients
  • Toxicological endpoints were skin sensitization, genotoxicity, and systemic toxicity, along with ADME (absorption, distribution, metabolism, excretion).

Validated and Non-Validated Alternatives

• There are validated alternatives for some endpoints (skin irritation, corrosion, phototoxicity, etc)
• Others (acute toxicity, subacute toxicity, etc.) have methods for refinement and reduction but are not fully validated replacements.

Information on AAT Methods Status

• TSAR (Tracking System for Alternative Methods towards Regulatory Acceptance) is an internet tool used for tracking AAT progress.

Regulatory-Accepted AAT Methods

• Specific OECD test methods are regulatory accepted, like reconstructed human epidermis for skin corrosion.

Epiderm™ and Episkin™ Models

• These models are used for in vitro testing that mimics human skin.

Computational (in silico) Models

• These models use computer simulations, databases, and algorithms to predict toxicological outcomes for a variety of endpoints.
  • Quantitative Structure-Activity Relationship (QSAR)
  • Read-Across approaches
  • Exposure Modeling

Latest Report by Cosmetics Europe

• Non-animal Approaches for Cosmetic Product Safety Assessment

From the 2023 Report

• 3D skin micronucleus and comet assays have been adapted for use with 3D skin models, demonstrating improvements in genotoxicity predictions.
• These modified methods could serve as a replacement for in vivo tests currently.

AAT Scientific Challenge

• New alternative approaches must provide equal consumer protection as previous methods.
• There is a lengthy regulatory acceptance process for new testing methods.
• Living organisms are fundamentally different from in vitro, ex vivo, or in silico models.
• Multiple tests may be needed for a variety of endpoints.

Bringing the Pieces of the Puzzle Together

• Includes education and training, case studies of test applicability, and regulatory acceptance of new safety assessment approaches for practical use.

Useful Internet Sources

• Relevant websites and databases for further research on AATs are provided.

Test your knowledge on the key components and assessments involved in the Cosmetic Product Safety Report. This quiz covers crucial aspects like chemical properties, safety assessments, and testing models related to cosmetic products. Challenge yourself to understand the details of safety evaluations in cosmetics!