title: Final report of the Cosmetic Ingredient Review Expert Panel amended safety assessment of Calendula officinalis-derived cosmetic ingredients.
abstract: Calendula officinalis extract, C officinalis flower, C officinalis flower extract, C officinalis flower oil, and C officinalis seed oil are cosmetic ingredients derived from C officinalis. These ingredients may contain minerals, carbohydrates, lipids, phenolic acids, flavonoids, tannins, coumarins, sterols and steroids, monoterpenes, sesquiterpenes, triterpenes, tocopherols, quinones, amino acids, and resins. These ingredients were not significantly toxic in single-dose oral studies using animals. The absence of reproductive/developmental toxicity was inferred from repeat-dose studies of coriander oil, with a similar composition. Overall, these ingredients were not genotoxic. They also were not irritating, sensitizing, or photosensitizing in animal or clinical tests but may be mild ocular irritants. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that these ingredients are safe for use in cosmetics in the practices of use and concentration given in this amended safety assessment.
authors.affiliation: Cosmetic Ingredient Review, Washington, DC 20036, USA. cirinfo@cir-safety.org
authors.forename: F Alan
authors.initials: FA
authors.lastname: Andersen
authors.forename: Wilma F
authors.initials: WF
authors.lastname: Bergfeld
authors.forename: Donald V
authors.initials: DV
authors.lastname: Belsito
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Hill
authors.forename: Curtis D
authors.initials: CD
authors.lastname: Klaassen
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Liebler
authors.forename: James G
authors.initials: JG
authors.lastname: Marks
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Shank
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Slaga
authors.forename: Paul W
authors.initials: PW
authors.lastname: Snyder
mesh_terms: D000818:Animals; D020838:Calendula / Q000737:chemistry / Q000633:toxicity*; D015197:Carcinogenicity Tests; D055598:Chemical Phenomena; D003257:Consumer Product Safety; D003358:Cosmetics / Q000737:chemistry / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D035264:Flowers / Q000737:chemistry; D006801:Humans; D007509:Irritants; D009152:Mutagenicity Tests; D010936:Plant Extracts / Q000737:chemistry / Q000633:toxicity*; D023382:Toxicity Tests, Acute; D036401:Toxicity Tests, Chronic
chemical_list: D003358:Cosmetics; D007509:Irritants; D010936:Plant Extracts