title: Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.
abstract: This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.
authors.affiliation: Cosmetic Ingredient Review Scientific Analyst/Writer, Washington, DC, USA.
authors.forename: Lillian C
authors.initials: LC
authors.lastname: Becker
authors.affiliation: Cosmetic Ingredient Review Toxicologist, Washington, DC, USA.
authors.forename: Ivan
authors.initials: I
authors.lastname: Boyer
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Wilma F
authors.initials: WF
authors.lastname: Bergfeld
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Donald V
authors.initials: DV
authors.lastname: Belsito
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Hill
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Curtis D
authors.initials: CD
authors.lastname: Klaassen
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Liebler
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: James G
authors.initials: JG
authors.lastname: Marks
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Shank
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Slaga
authors.affiliation: Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Snyder
authors.affiliation: Former Director, Cosmetic Ingredient Review, Washington, DC, USA.
authors.forename: F Alan
authors.initials: FA
authors.lastname: Andersen
mesh_terms: D000536:Aluminum Hydroxide / Q000032:analysis / Q000493:pharmacokinetics / Q000633:toxicity*; D000537:Aluminum Oxide / Q000032:analysis / Q000493:pharmacokinetics / Q000633:toxicity*; D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D003358:Cosmetics / Q000737:chemistry / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards; D033161:Government Regulation; D006801:Humans; D015394:Molecular Structure; D018675:Toxicity Tests / Q000379:methods; D066007:Toxicokinetics; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003358:Cosmetics; D000536:Aluminum Hydroxide; D000537:Aluminum Oxide
keywords: alumina; aluminum hydroxide; cosmetics; safety