Safety Tests in Cosmetics 15 week

Safety Tests in Cosmetics A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use.

Safety Tests in Cosmetics Several mechanisms have been developed regarding consumer health protection: List of chemicals which must not be contained. List of substances which cosmetic products must not contain except under restrictions. List of authorized substances, which may include coloring agents, preservatives and ultraviolet filters. GUIDELINES

Safety Tests in Cosmetics INGREDIENTS FINISHED COSMETIC PRODUCTS

Safety Assessment of Cosmetic Ingredients Acute toxicity Skin absorption Skin irritation Mucous membrane irritation Skin sensitisation Subchronic toxicity Phototoxicity and photomutagenicity (in case of UV-light absorbing substances

Safety Assessment of Cosmetic Ingredients Mutagenicity Human data (if available) Toxicokinetics Teratogenicity, reproduction toxicity, carcinogenicity, additional genotoxicity Metabolism studies

Material Safety Data Sheets (MSDS) MSDS is a form containing data regarding the properties of a particular substance. Product stewarding and workplace safety: provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner.

Material Safety Data Sheets (MSDS) Chemical product and company identification Composition/information on ingredients : CAS number, conc., etc. Hazards identification First aid measures Fire fighting measures Accidental release measures Handling and storage Exposure controls/personal protection

Safety Assessment (Finished Cosmetic Products) Compatibility test: a test intended to confirm that there are no harmful effects when applying a cosmetic product for the first time to the human skin or mucous membrane.

Controlled Use Test Performed under normal or slightly exaggerated use conditions. Exposure/application conditions (which may vary widely for different product types) and evaluations are controlled and standardized.

(Uncontrolled) Use Test at Home Test under normal use conditions. Participants may be selected to represent different categories of consumer, e.g., of particular skin types. Large groups of volunteers and over a test period of a duration which is considered to be adequate to evaluate skin compatibility under normal, uncontrolled, use conditions at home, with periodic expert assessments of skin condition, and including comments by the volunteers on subjective effects. May be useful in assessment of product efficacy and acceptability

Subject Selection Number - enough to satisfy the test objective. Recruitment – inclusion / exclusion criteria. Volunteers must be clearly informed, verbally and in writing, regarding the nature of the study, timetable, constraints, possible risks. Give the written informed consent.

Test Sample(s) Reference samples – to check inter-/intra-laboratory variations, inter-seasonal variability. Concentration – adjusted/diluted according to the type of product, test protocol, study objective so as not to cause severe skin effects.

Dose Level Patch tests - measured amount of test material. Use-related tests – quantity applied should be relevant to that expected to be used at home.

Removal of Test Sample When appropriate, test product(s) will be removed in the laboratory by a technician. Test sample(s) will be rinsed (or otherwise gently removed) from application sites without rubbing to avoid cross-contamination.

Assessments: Patch Tests VISUAL ASSESSMENT of skin compatibility: scored by same experienced assessor who made the baseline assessment. Same lighting source. Predefined scoring scale.

Assessments: Patch Tests INSTRUMENTAL MEASUREMENT Measured after an acclimatization period in an environmentally conditioned room. Instruments must be calibrated regularly

Data Interpretation Statistical analysis must be valid and specified in the protocol. Usually compare the new test product with those of positive and/or negative controls, or similar products with a substantial history of safety in the market.

Conclusion Cosmetic ingredients: MSDS Finished cosmetic products: Single application open epicutaneous test Repeated application open epicutaneous test Single application closed patch epicutaneous test Repeated application closed patch epicutaneous test

in vitro Testing for Ocular Safety BCOP - Bovine Cornea Opacity and Permeability Test; FLT - Fluorescein Leakage Test; HET-CAM - Hen’s Egg Test - Chorioallantoic Membrane; RBC - Red Blood Cell Test; TEA - Tissue Equivalent Assay.

In vivo testing