The safety of phenyl trimethicone has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that phenyl trimethicone was safe for use in cosmetics and personal care products. In 2004, as part of the scheduled re-evaluation of ingredients, the Expert Panel considered available new data on phenyl trimethicone and reaffirmed the above conclusion.
Expert Panel for Cosmetic Ingredient Safety Review
The Expert Panel reviewed acute oral data showing that phenyl trimethicone was relatively nontoxic as well as acute and subchronic dermal studies showing that phenyl trimethicone was nontoxic. Phenyl trimethicone was nonirritating to the skin under both intact and abraded conditions and was not a sensitizer. The ingredient was not an eye irritant and was nonmutagenic both with and without metabolic activation when evaluated in bacteria. Phenyl trimethicone was not a developmental toxicant when applied dermally.
The doses tested were comparatively greater than the concentrations used in cosmetics and personal care products. Phenyl trimethicone was neither an irritant nor a sensitizer to humans. The UV spectrum indicated only weak absorbance at 327 nm, and the Expert Panel concluded that it is unlikely that phenyl trimethiocne was a phototoxicant or a photosensitizer.
Phenyl trimethicone may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.