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Final Report on the Safety Assessment of Squalane and Squalene

Squalane and Squalene have been identified as natural components of human sebum. Both ingredients are used in a variety of cosmetics at concentrations ranging from ≤0.1 to >50%. Animal studies indicate Squalene is slowly absorbed through the skin, while both compounds are poorly absorbed from the gastrointestinal tract. The acute animal toxicity of these ingredients by all routes is low. Both compounds are nonirritants to rabbit skin and eye at 100% concentration. Formulations containing Squalene indicate it is not a significant human skin irritant or sensitizer. Limited contact sensitization tests indicate Squalene is not a significant contact allergen or irritant. It is concluded that both Squalane and Squalene are safe as cosmetic ingredients in the present practices of use and concentration.