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Safety of medicinal comfrey cream preparations (Symphytum officinale s.l.): The pyrrolizidine alkaloid lycopsamine is poorly absorbed through human skin
- Source :
- Regulatory toxicology and pharmacology : RTP. 118
- Publication Year :
- 2020
-
Abstract
- European Union guidelines indiscriminately discuss a permitted daily exposure (PDE) for pyrrolizidine alkaloids (PA) of up to 0.007 μg/kg body weight for oral and for topical exposure to herbal medicinal products. In this study, lycopsamine served as a model substance for measuring the extent of skin permeation of PAs following the application of a spiked comfrey cream (Symphytum officinale s.l.) to abdominal skin from human donors in Franz diffusion cells. PAs could be excluded in the non-spiked cream with a limit of detection of 8 μg/kg. Only small amounts of the applied quantity of lycopsamine had migrated through the skin sample into the receptor cell side of the diffusion cell after 24 h. In five of six diffusion cells, there was no detectable lycopsamine within the skin and only 0.6 ± 0.4% of the applied dose in the receptor fluid. The theoretical skin penetration of 4.9% of the applied quantity of lycopsamine largely resulted from the worst case approach of assuming the presence of at least a quantity corresponding to the limit of detection – the true penetration is probably considerably lower. Even with the worst-case calculation, the currently discussed guidelines on PA overestimate the risk related to topical preparations.
- Subjects :
- Adult
Pyrrolizidine alkaloid
Skin Absorption
Skin Cream
Comfrey
Biological Availability
Human skin
010501 environmental sciences
Toxicology
Administration, Cutaneous
030226 pharmacology & pharmacy
01 natural sciences
Risk Assessment
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Symphytum officinale
media_common.cataloged_instance
Humans
European union
Pyrrolizidine Alkaloids
0105 earth and related environmental sciences
media_common
Aged
Skin
Detection limit
Traditional medicine
biology
Plant Extracts
General Medicine
Middle Aged
biology.organism_classification
3. Good health
Lycopsamine
chemistry
Pyrrolizidine
Female
Subjects
Details
- ISSN :
- 10960295
- Volume :
- 118
- Database :
- OpenAIRE
- Journal :
- Regulatory toxicology and pharmacology : RTP
- Accession number :
- edsair.doi.dedup.....771ce03bb1f72f3a8315a0221a601a4f