Abstract
Carrageenan has been widely used as food additive for decades and therefore, an extended oral data set is available in the public domain. Less data are available for other routes of administration, especially intranasal administration. The current publication describes the non-clinical safety and toxicity of native (non-degraded) iota-carrageenan when applied intranasally or via inhalation. Intranasally applied iota-carrageenan is a topically applied, locally acting compound with no need of systemic bioavailability for the drug’s action. Animal experiments included repeated dose local tolerance and toxicity studies with intranasally applied 0.12% iota-carrageenan for 7 or 28 days in New Zealand White rabbits and nebulized 0.12% iota-carrageenan administered to F344 rats for 7 days. Permeation studies revealed no penetration of iota-carrageenan across nasal mucosa, demonstrating that iota-carrageenan does not reach the blood stream. Consistent with this, no relevant toxic or secondary pharmacological effects due to systemic exposure were observed in the rabbit or rat repeated dose toxicity studies. Data do not provide any evidence for local intolerance or toxicity, when carrageenan is applied intranasally or by inhalation. No signs for immunogenicity or immunotoxicity have been observed in the in vivo studies. This is substantiated by in vitro assays showing no stimulation of a panel of pro-inflammatory cytokines by iota-carrageenan. In conclusion, 0.12% iota-carrageenan is safe for clinical use via intranasal application.
Highlights
Carrageenan is a generic name for a family of gel-forming and viscosifying polysaccharides, which are obtained by extraction from certain species of red seaweeds of the class Rhodophyceae
An extensive set of safety data on native and degraded carrageenan is published in the public domain
Term studies involving different dosages / concentrations of degraded and non-degraded forms, different subtypes, and various animal studies including mice, rats, rabbits, hamsters, ferrets, dogs, rhesus monkeys, squirrel monkeys, pigs, gerbils, baboons, and chick embryos [19, 24,25,26]. These studies mainly aimed at supporting the safety of carrageenan for use as food additive in various food products for adults and children / infants
Summary
Carrageenan is a generic name for a family of gel-forming and viscosifying polysaccharides, which are obtained by extraction from certain species of red seaweeds of the class Rhodophyceae. Safety Evaluation of Iota-Carrageenan financed by Marinomed Biotechnologie GmbH. Native iota-carrageenan was chosen for further investigations on intranasal use based on its beneficial overall safety profile. We aimed at investigating the non-clinical safety and toxicity of native (non-degraded) iota-carrageenan after intranasal administration. In a first 7-day repeated dose toxicity study information on the toxicity and intranasal local tolerance of iota-carrageenan in female rabbits after 4 times daily intranasal administration over a period of 7 days was evaluated. In a follow-on study iota-carrageenan was administered intranasally to rabbits for 28 consecutive days; two different dosing schemes were evaluated. In vitro studies aimed at evaluating the permeation behavior of iotacarrageenan on bovine nasal mucosa and to analyze potential pro-inflammatory effects of carrageenan in the murine dendritic / monocytic cell line DC18C10, stably transfected with a TNF-α luciferase reporter gene construct
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