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Approach to Skin Testing

For P&G Beauty & Grooming products, skin is the primary site of application and action. Therefore, skin safety is a high priority to P&G. Many ingredients used in beauty products have a long history of safe use on the skin. However, in cases where scientists are dealing with a new ingredient or a new exposure to an existing ingredient, the primary safety concerns for a skin care product are skin irritation and skin allergy (sensitization). A large number of testing protocols have been developed specifically to test ingredients and products for these endpoints. In order to be conservative, all these tests rely on some exaggeration of concentration.

Finished Product Safety

Skin Irritation

Skin irritation tests are designed to assess the potential irritancy to human skin after repeated contact with diluted or undiluted products. In order to ensure an adequate margin of safety, testing may be conducted under conditions that exaggerate potential exposure. In vitro test methods are often used in the initial evaluation process to predict skin irritation potential. P&G scientists were instrumental in developing and validating new in vitro methods for skin irritation. If necessary, clinical testing with human subjects can be conducted, to confirm that the product's mildness to skin is indeed what researchers had predicted it would be from the risk assessment. Learn more about in vitro cornea and skin work »

Skin Allergy

The safety evaluation of skin allergy is a significant part of every product assessment for P&G Beauty & Grooming. A sensitization reaction is more serious than a transient irritation reaction, since the development of an allergy is irreversible.

Traditionally, skin compatibility for a finished product included a confirmatory human volunteer study such as the Human Repeated Insult Patch Test to verify the lack of skin allergy. Recently P&G scientists were in the forefront of developing a process for safety assessment of fragrance materials that used existing data on the individual ingredients within a fragrance rather than conducting human clinical testing of every new fragrance. The concept led to the development of a similar approach called Quantitative Risk Assessment (QRA) by the Research Institute for Fragrance Materials (RIFM), the leading fragrance safety institute in the world, in conjunction with the International Fragrance Association (IFRA). IFRA refers to QRA "as the core strategy for primary prevention of dermal sensitization (allergy) to materials in consumer products in general." P&G uses this same process as a key part of its fragrance safety assessments for skin allergy. 

Additionally, companies often use confirmatory photosensitization test protocols that combine exposure to an ingredient or product with light under controlled conditions to assess photo reactivity. Photosensitization potential is evaluated because light is known to exacerbate allergic responses in certain instances.

Skin Safety Claims

In addition to ensuring that our products are safe from skin irritation and sensitization, P&G also makes safety claims that can be found on a product label. Examples of such claims include "hypoallergenic," "safe for sensitive skin" and "mild on skin." Although the cosmetics industry is highly regulated, there is no consistent set of guidelines or definitions governing such claims, nor are manufacturers required to substantiate them with the FDA. Nevertheless, guidelines have been developed within P&G for substantiating these non-therapeutic claims. In many cases, substantiation of these claims is conducted with human subjects under highly controlled conditions. P&G ensures that there is solid scientific support for claims and that all regulatory and legal requirements in a given market are met.

Sharing our Science

P&G works with outside, independent dermatologists and scientists to constantly evaluate and re-evaluate product safety. The objective of these independent reviews is to point out gaps in our tests, or errors in interpretation of the results or conclusions. This critique of our testing program is a valuable tool in ensuring that P&G provides the consumer with the safest products on the market.

Resources

Engasser, P., T. Long, P. McNamee, H. Schlatter and J. Gray, 2007. Safety of Cosmetic Products. Journal of Cosmetic Dermatology 6: 23-31.
Felter S.P., C.A. Ryan, D.A. Basketter and G.F. Gerberick, 2003.. Application of the Risk Assessment Paradigm to the Induction of Allergic Contact Dermatitis. Regulatory Toxicol Pharmacol 37: 1-10.
Gerberick G.F., M.K. Robinson, S. P. Felter, I.R. White and D.A. Basketter, 2001. Understanding Fragrance Allergy Using an Exposure-Based Risk Assessment Approach. Contact Dermatitis 45: 333-40.
Gerberick, G. F. and M. K. Robinson, 2000. A Skin Sensitization Risk Assessment Approach for Evaluation of New Ingredients and Products. Am. J. Contact Dermatitis 11(2):65-73.
Gerberick, G. F. and M. K. Robinson, and J. Stotts, 1993. An Approach to Allergic Contact Sensitization Risk Assessment of New Chemicals and Product Ingredients. Am. J. Contact Dermatitis 4(4):205-211.
Robinson, M. K., J. Stotts, P. J. Danneman and T. L. Nusair, 1989. A Risk Assessment Process for Allergic Contact Sensitization. Fd. Chem. Toxic. 27(7):479-489.
M.J. How et al., 1989. The A.I.S. Approach to Assessment of Product Safety. Tenside Surf. Det. 26(3):231-236.  
P&G Beauty, 2007.  Cosmetic Product Safety Research Update
J. Stotts, 1980. Planning, Conduct, and Interpretation of Human Predictive Sensitization Patch Tests. In: Current Concepts in Cutaneous Toxicology, Academic Press, Orlando, 41-53.
Suskind, R. R., M. M. Meister, S. R. Scheen, D. J. A. Rebello, 1963. Cutaneous Effects of Household Synthetic Detergents and Soaps. Arch Dermatol, 88:117-124.
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