Preclinical studies of hydroalcoholic extract of Calea uniflora Less / Estudios preclínicos de extracto hidroalcohólico de Calea uniflora Less

Calea uniflora Less known popularly as Arnica in Brazil, is a native plant from Brazil, popular used by coastal populations from south of Santa Catarina. The purpose of this study was to verify the safety profile in of hydroalcoholic extract of C. uniflora in florescences.The hydroalcoholic extract of C. uniflora in florescences was evaluated for its acute and sub-acute toxicity. Acute topical toxicity was performed using the methodology of guideline 402 from OECD. Acute oral toxicity was performed using the methodology of guideline 423 from OECD and sub-acute toxicity was performed using the methodology adapted of guideline 407 from OECD. The single dose for oral or topical administration of C. uniflora showed DL50> 5000 mg/kg b.w. The sub-acute treatment induced animal death in groups, which was administered extract in the doses 100, 250, 500 and 1000 mg/kg. The main signs of toxicity observed were respiratory difficulty, increase in lung weigh, lung damage and muscular relation. The topical or oral administration of C. uniflora extract in short period did not caused toxicological effects in animals, however, when administered for a longer period and in concentrations of 250, 500 and 1000 mg/kg (oral.) caused lung damage and even the death of the animal.

Calea uniflora Less conocida popularmente como Arnica en Brasil, es una planta nativa de Brasil, popularmente utilizada por poblaciones costeras del sur de Santa Catarina. El objetivo de este estudio fue verificar el perfil de seguridad del extracto hidroalcoólico de inflorescencias de C. uniflora. El extracto hidroalcoólico de inflorescencias de C. uniflora fue evaluado en cuanto a su toxicidad aguda y subaguda. La toxicidad tópica aguda se realizó utilizando la metodología de la directriz 402 de la OECD. La toxicidad oral aguda fue realizada usando la metodología de la directriz 423 de la OECD y la toxicidad subaguda fue realizada usando la metodología adaptada de la directriz 407 de la OECD. La dosis única para administración oral o tópica de C. uniflora mostro DL50> 5000 mg/kg. El tratamiento subagudo indujo la muerte de animales en grupos a los que se administró extracto en las dosis de 100, 250, 500 y 1000 mg/kg. Los principales signos de toxicidad observados fueron dificultad respiratoria, aumento del peso del pulmón, daño pulmonar y relación muscular. La administración tópica oral del extracto de C. uniflora a corto plazo no causó efectos toxicológicos en los animales, mientras que, cuando se administró por un período mayor y en las concentraciones de 250, 500 y 1000 mg/kg (oral) causaron danos en los pulmones y hasta la muerte del animal.

Final report on the safety assessment of Arnica montana extract and Arnica montana.

Arnica Montana Extract is an extract of dried flowerheads of the plant, Arnica montana. Arnica Montana is a generic term used to describe a plant material derived from the dried flowers, roots, or rhizomes of A. montana. Common names for A. montana include leopard's bane, mountain tobacco, mountain snuff, and wolf's bane. Two techniques for preparing Arnica Montana Extract are hydroalcoholic maceration and gentle disintegration in soybean oil. Propylene glycol and butylene glycol extractions were also reported. The composition of these extracts can include fatty acids, especially palmitic, linoleic, myristic, and linolenic acids, essential oil, triterpenic alcohols, sesquiterpene lactones, sugars, phytosterols, phenol acids, tannins, choline, inulin, phulin, arnicin, flavonoids, carotenoids, coumarins, and heavy metals. The components present in these extracts are dependent on where the plant is grown. Arnica Montana Extract was reported to be used in almost 100 cosmetic formulations across a wide range of product types, whereas Arnica Montana was reported only once. Extractions of Arnica Montana were tested and found not toxic in acute toxicity tests in rabbits, mice, and rats; they were not irritating, sensitizing, or phototoxic to mouse or guinea pig skin; and they did not produce significant ocular irritation. In an Ames test, an extract of A. montana was mutagenic, possibly related to the flavenoid content of the extract. No carcinogenicity or reproductive/developmental toxicity data were available. Clinical tests of extractions failed to elicit irritation or sensitization, yet Arnica dermatitis, a delayed type IV allergy, is reported in individuals who handle arnica flowers and may be caused by sesquiterpene lactones found in the flowers. Ingestion of A. montana-containing products has induced severe gastroenteritis, nervousness, accelerated heart rate, muscular weakness, and death. Absent any basis for concluding that data on one member of a botanical ingredient group can be extrapolated to another in the 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.

Uso sistêmico da arnica(solidago microglossa DC) em cicatrizaçäo de feridas cutâneas abertas em ratos / Systemic use of arnica(solidago microglossa DC) on cicatrization of open cutaneous wounds of rats

A utilizaçao de plantas na medicina popular vem ocorrendo de modo indiscriminado e muitas vezes sem base científica sólida. Uma destas plantas, a arnica (Solidago microglossa DC) tem seu uso bastante difundido em nosso meio. O objetivo desta pesquisa foi testar o efeito do extrato aquoso da planta, em aplicaçao sistémica, sobre a cicatrizaçao de feridas cutâneas abertas e a funçao hepática de ratos. Noventa ratos albinos, machos, peso médio 311 g, foram distribuídos em: grupo controle que nao sofreu nenhum procedimento, grupo simulado que recebeu o diluente e o grupo que recebeu doses diárias intraperitoneais de 5mg.mL-1 de arnica em soluçao salina. A dose aplicada foi escolhida após ensaio biológico da determinaçao da DL50 e DL100. Anestesiados com xilazina e quetamina intramuscular, os animais foram submetidos a exérese de um retalho dermato-cutâneo dorsal padronizado e posteriormente observados por períodos de sete ou quatorze dias. Avaliou-se: a evoluçao ponderal; as áreas das feridas operatórias; as dosagens séricas da ALT (alanina amino-transferase) e AST (aspartato amino-transferase); a absorbância dos espectros visível e ultravioleta de preparaçoes de arnica no extrato liofilizado, fígado e no soro dos animais; a presença de tecido de granulaçao, fibras colágenas, células mononucleares, polimorfonucleares na ferida operatória com microscopia de luz; a presença de alteraçoes nas mitocôndrias, retículo endoplasmático granular e degeneraçoes citoplasmáticas das células hepáticas com microscopia eletrônica de transmissao (MET). Os achados mostraram uma perda ponderal nos animais do grupo estudo aos sete dias, porém estabilizada aos quatorze dias. A área de cicatrizaçao foi menor no grupo que usou a arnica, mais significante aos quatorze dias de observaçao. As atividades enzimáticas da ALT e AST nao foram diferentes nos diversos grupos, embora alguns animais do grupo estudo ocorreram alteraçoes nao significantes de organelas citoplasmáticas (degeneraçao gordurosa) na MET. A absorbância nao foi conclusiva por limitaçoes de sensibilidade do método aplicado. Concluiu-se que a dose de 5mg.mL'1 de extrato aquoso liofilizado de arnica por via intraperitoneal promove uma reduçao significante da área das feridas cutâneas abertas de ratos aos quatorze dias de observaçao, em relaçao aos animais que receberam somente soluçao salina ou nenhum tipo de tratamento; e que a dose empregada nao exibe sinais de toxicidade hepática detectável pela sorologia e...