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Preclinical Safety Assessment of Cosmetics & Toiletries

Preclinical Safety Assessment of Cosmetics & Toiletries. Raman Govindarajan, MD, PhD. Regional Director Medical and Scientific Affairs Johnson and Johnson Asia Pacific. Preclinical Safety Assessment. Outline: Cosmetic & Toiletry Products Safety Review of Cosmetic Ingredients

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Preclinical Safety Assessment of Cosmetics & Toiletries

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  1. Preclinical Safety Assessment of Cosmetics & Toiletries Raman Govindarajan, MD, PhD. Regional Director Medical and Scientific Affairs Johnson and Johnson Asia Pacific

  2. Preclinical Safety Assessment Outline: • Cosmetic & Toiletry Products • Safety Review of Cosmetic Ingredients • Safety Review of Active Ingredients and Products

  3. Preclinical Safety Assessment Cosmetic & Toiletry Products Cosmetics – least regulated Companies bear the burden of proof on the safety of cosmetic products

  4. Preclinical Safety Assessment Sources of Safety Information for Cosmetic Ingredients • Cosmetic Ingredient Review (CIR) - CTFA • Prohibited Ingredients and other Hazardous Substance – FDA • California Proposition 65 List - California EPA • List of Suspected Carcinogens - NTP • Federal Insecticide, Fungicide and Rodenticide Act - EPA

  5. Preclinical Safety Assessment Sources of Safety Information for Cosmetic Ingredients • Industry Guidelines to Restrict Ingredient Usage - IFRA • Approved Colorant list (limited) - FDA • Endocrine Disruptor Screening Program - EPA • Voluntary Children’s Health Chemical Evaluation Program – EPA • COLIPA - EU • Pubmed - Toxnet

  6. Preclinical Safety Assessment Toxicity/Preclinical Safety Review • Single Dose Study: IV, IP, Dermal, Oral • Multiple Dose Study: Subacute, Subchronic, Chronic • Organ toxicity – structural and functional • Carcinogenicity Study: Dermal, Oral

  7. Toxicology: Fundamentals Special Toxicity Studies • Ocular Irritation • Dermal Irritation/Sensitization • Photo-Irritation/Sensitization • Reproductive Tests, Embryo toxicity, teratology tests • Mutagenicity Tests

  8. Preclinical Safety Assessment Additional Studies to support claims • Genital/Mucus Membrane Irritation Test • Ocular Irritation (Draize, TEP) Test • Comedogenicity Test

  9. Preclinical Safety Assessment Other information required to access safety • Skin Absorption Data • Toxicokinetics/Pharmacokinetics Data

  10. Safety testing of ingredients and formulations • Is there a need to test formulations if ingredients are safe • Interactions during processing – pH, temperature • Interaction within formulation – impurities • Interaction within the body • Interaction with other products used • Misuse, overuse, unintended use

  11. Preclinical Safety Assessment • Safety Evaluation for External Color Additives • [From 21 CFR Ch.1 Subpart C, 70.40 (4-1-99)] • Safety factor should be 100 to 1 (based on NOEAL in most sensitive species) • Safety of external color additives will be determined • by: Acute Oral Toxicity • Primary Irritation /Contact Sensitization • Subacute Dermal Toxicity on intact/abraded skin • Dermal Carcinogenicity

  12. q IV q Dermal SINGLE DOSE q IP q Oral : TOXICITY q Subacute q Chronic MULTIPLE DOSE q Subchronic : TOXICITY q Dermal q Oral ARCINOGENICITY S q Primary Skin q Contact Sensitization PECIAL Irritation q Eye Irritation T : OXICITY q Cumulative Skin Irritation q Comedogenicity q Genital/Mucus Mem. Irritation S S : q ( ) q Photo - q Photocar OLAR PECTRUM mutagenicity cinogenicity q Phototoxicity q Photosensitization R q Segment II (Rat, q Segment I (Rat) EPRODUCTIVE Rabbit) q Segment III (Rat) T : OXICITY M : q Ames Test q Mammalian UTAGENICITY q Mouse Micronucleus Chromosomal Aberration O : q Skin Absorption THERS

  13. Non animal test methods • In vitro testing • Human testing • On satisfactory data being available only

  14. Preclinical Safety Assessment/US • Most naturals have established long safe use history via oral route • Not enough safety information with ocular and dermal exposure • Safety issues are mostly related to irritation /sensitization and photo-irritation /sensitization • Batch to batch variation • FIFRA and California Prop 65 Safety Review of Naturals-Containing Products

  15. Preclinical Safety Assessment/US • Dependent on the intended use of the enzyme (cosmetic, food, laundry detergent) • Potential exposure route under normal or accidental contact (oral, eye, skin, inhalation) • Major health effects associated with enzymes are related to irritation and sensitization Safety Review of Enzyme-Containing Products

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