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Chemical Information Review Document for Arbutin [CAS No 497-76-7
Chemical Information Review Document
for
Arbutin [CAS No. 497-76-7] and
Extracts from Arctostaphylos uva-ursi
Supporting Nomination for Toxicological Evaluation by the
National Toxicology Program
January 2006
Prepared by:
Integrated Laboratory Systems, Inc.
Research Triangle Park, NC
Under Contract No. N01-ES-35515
Prepared for:
National Toxicology Program
National Institute of Environmental Health Sciences
National Institutes of Health
U.S Department of Health and Human Services
Research Triangle Park, NC
/
Abstract
Arbutin is found in the dried leaves of a number of different plant species including bearberry
(Arctostaphylos uva-ursi). The leaves and leaf extracts from uva ursi are used in non-prescription
medicinal products mainly to treat urinary tract infection, cystitis, kidney stones, and as a diuretic. The
active component, arbutin, is converted to hydroquinone (HQ) which has antimicrobial, astringent, and
disinfectant properties. Arbutin is also an inhibitor of melanin formation and is use in some skin-
lightening products. It is rapidly metabolized and excreted in rats as unchanged arbutin and in humans as
HQ, HQ glucuronide, and HQ sulfate. HQ induced renal tubule adenomas in male rats and liver
adenomas and thyroid gland follicular cell hyperplasia in mice. It was negative in the Ames assay but
induced mutations and micronuclei in mouse L5178Y lymphoma and chromosome aberrations and sister-
chromatid exchange in Chinese hamster ovary cells. Side effects reported from the ingestion of dried uva
ursi leaves included nausea and vomiting, irritability, insomnia, and an increased heart rate. Extremely
high doses can cause ringing in the ears, shortness of breath, convulsions, collapse, and delirium. Uva
ursi has also been linked with albuminuria, hematuria, and urine cast; liver damage is also a risk with
long-term use. In vitro studies of human melanocytes exposed to arbutin a
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