Final report on the safety assessment of Calendula officinalis extract and Calendula officinalis.

Calendula Officinalis Extract is an extract of the flowers of Calendula officinalis, the common marigold, whereas Calendula Officinalis is described as plant material derived from the flowers of C. officinalis. Techniques for preparing Calendula Officinalis Extract include gentle disintegration in soybean oil. Propylene glycol and butylene glycol extractions were also reported. Components of these ingredients are variously reported to include sugars, carotenoids, phenolic acids, sterols, saponins, flavonoids, resins, sterins, quinones, mucilages, vitamins, polyprenylquinones, and essential oils. Calendula Officinalis Extract is reported to be used in almost 200 cosmetic formulations, over a wide range of product categories. There are no reported uses of Calendula Officinalis. Acute toxicity studies in rats and mice indicate that the extract is relatively nontoxic. Animal tests showed at most minimal skin irritation, and no sensitization or phototoxicity. Minimal ocular irritation was seen with one formulation and no irritation with others. Six saponins isolated from C. officinalis flowers were not mutagenic in an Ames test, and a tea derived from C. officinalis was not genotoxic in Drosophila melanogaster. No carcinogenicity or reproductive and developmental toxicity data were available. Clinical testing of cosmetic formulations containing the extract elicited little irritation or sensitization. Absent any basis for concluding that data on one member of a botanical ingredient group can be extrapolated to another in a group, or to the same ingredient extracted differently, these data were not considered sufficient to assess the safety of these ingredients. Additional data needs include current concentration of use data; function in cosmetics; ultraviolet (UV) absorption data; if absorption occurs in the UVA or UVB range, photosensitization data are needed; gross pathology and histopathology in skin and other major organ systems associated with repeated dermal exposures; dermal reproductive/developmental toxicity data; inhalation toxicity data, especially addressing the concentration, amount delivered, and particle size; and genotoxicity testing in a mammalian system; if positive, a 2-year dermal carcinogenicity assay performed using National Toxicology Program (NTP) methods is needed. Until these data are available, it is concluded that the available data are insufficient to support the safety of these ingredients in cosmetic formulations.