Xanthan gum: Safety evaluation by two-year feeding studies in rats and dogs and a three-generation reproduction study in rats

Woodard, Geoffrey E.; Woodard, Meredith; McNeely, William H.; Kovács, P.; Cronin, M. T. I.

doi:10.1016/0041-008x(73)90178-6

Cited by 22 publications

(13 citation statements)

References 7 publications

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“…Our study demonstrated that ARMS-I was safe and had no drug-related adverse effects. This is to be expected, based on the known safety profile of the active ingredients and their long history of use in humans [41][42][43][44][45][46]. The novel, patented ARMS-I formulation contains cetylpyridinium chloride (CPC) as an antimicrobial, and xanthan gum and glycerin as the barrier forming agents.…”

Section: Discussionmentioning

confidence: 99%

Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections

et al. 2017

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BackgroundCurrent prevention options for upper respiratory infections (URIs) are not optimal. We conducted a randomized, double-blinded, placebo-controlled pilot clinical trial to evaluate the safety and efficacy of ARMS-I™ (currently marketed as Halo™) in the prevention of URIs.MethodsARMS-I is patented novel formulation for the prevention and treatment of influenza, comprising a broad-spectrum antimicrobial agent (cetylpyridinium chloride, CPC) and components (glycerin and xanthan gum) that form a barrier on the host mucosa, thus preventing viral contact and invasion. Healthy adults (18–45 years of age) were randomized into ARMS-I or placebo group (50 subjects each). The drug was sprayed intra-orally (3× daily) for 75 days. The primary objectives were to establish whether ARMS-I decreased the frequency, severity or duration of URIs. Secondary objectives were to evaluate safety, tolerability, rate of virus detection, acceptability and adherence; effect on URI-associated absenteeism and medical visits; and effect of prior influenza vaccination on study outcomes.ResultsOf the 94 individuals who completed the study (placebo: n = 44, ARMS-I: n = 50), six presented with confirmed URI (placebo: 4, ARMS-I: 2), representing a 55% relative reduction, albeit this was statistically not significant). Influenza, coronavirus or rhinovirus were detected in three participants; all in the placebo group. Moreover, frequency of post-treatment exit visits was reduced by 55% in ARMS-I compared to the placebo group (N = 4 and 2, respectively). Fever was reported only in the placebo group. ARMS-I significantly reduced the frequency and severity of cough and sore throat, and duration of cough (P ≤ .019 for all comparisons). ARMS-I was safe, well tolerated, had high acceptability and high adherence to medication use. Medical visits occurred only in the placebo group while absenteeism did not differ between the two arms. Prior influenza vaccination had no effect on study outcome.ConclusionsThis randomized proof-of-concept clinical trial demonstrated that ARMS-I tended to provide protection against URIs in the enrolled study participants, while reducing severity and duration of cough and sore throat. A clinical trial with a larger number of study participants is warranted.Trial registrationClinicalTrials.gov NCT02644135 (retrospectively registered).Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-016-2177-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections

et al. 2017

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“…There was no notable toxicity observed in those studies for xanthan gum concentrations up to 20 g/kg body weight (Booth et al 1963;Eastwood et al 1987;McNeely and Kovacs 1975;Robbins et al 1964;Woodard et al 1973). The reproductive and developmental toxicity of xanthan was evaluated in a three-generation study with albino rats fed with xanthan (0-0.5 g/kg body weight).…”

Section: Toxicity Assessment Of Bacterial Polysaccharidesmentioning

confidence: 99%

“…The reproductive and developmental toxicity of xanthan was evaluated in a three-generation study with albino rats fed with xanthan (0-0.5 g/kg body weight). There were no significant differences in the developmental parameters between test and controls, and no malformations were observed (Woodard et al 1973). The dermal irritation and sensitization potentials of xanthan gum were evaluated in animal studies.…”

Section: Toxicity Assessment Of Bacterial Polysaccharidesmentioning

confidence: 99%

Bacterial Polysaccharides: Production and Applications in Cosmetic Industry

2015

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“…The toxicological database of xanthan gum includes a subchronic (90 days rodent feeding) study and a 2-year carcinogenicity study in rats each with an NOAEL of 1000 mg/kg bw/d, and a three-generation rat study with an NOAEL of 500 mg/kg bw/d. 150,151 These NOAELs were the highest doses tested. Although experimental mutagenicity/genotoxicity data were not identified, there is an absence of any such structural alert.…”

Section: Xanthan Gummentioning

confidence: 99%

“…Long-term studies in rats and dogs demonstrated the absence of any effects on tumor incidence. 151 Dietary dog studies over 12 and 107 weeks with up to 1000 mg/kg bw/d demonstrated a lack of toxicological effects. 151 However, a conservative NOAEL was considered at 250 mg/kg bw/d in both studies due to softer stools than controls at higher doses, and a slight reduction in growth in males, neither of which were considered treatment related.…”

Section: Xanthan Gummentioning

confidence: 99%

An integrated approach to the safety assessment of food additives in early life

Constable

Mahadevan

Pressman³

et al. 2017

Toxicology Research and Application

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During the development of international standards by the Codex Alimentarius Commission, infant foods and their constituent ingredients are subject to rigorous risk analysis and are strictly regulated by many authorities. Various jurisdictions have approved only a limited number of additives specifically with regard to infant foods to fulfill specific technical requirements of quality. As part of the approval process, a rigorous safety assessment is essential to confirm that the use of additives does not pose any health risk for the consumer. An acceptable daily intake (ADI) may be derived from the toxicological databases. However, the ADI may not be applicable to infants because of the possible developmental sensitivities and potentially high exposure scenarios, leading to possible lower margins of safety than would often be determined for adult populations. There is interest in defining better food safety assessment approaches for pre-weaned infants aged less than 12-16 weeks. To confirm safe use in infants, we reviewed the suitability of the existing safety databases of six additives with historical uses in infant nutrition products. To determine further toxicity testing strategies, it is necessary to understand whether the chemical used in the additives is identical to endogenous physiological metabolites and/or whether immature organs of infants are targets of toxicity. Combined with an in-depth review of the existing relevant toxicological and nutritional studies, this integrated approach will facilitate decision-making. We propose a decision tree as a tool within this approach to help guide appropriate data requirements and identify data gaps. In cases of reasonable uncertainty, studies of targeted juvenile should be considered to investigate the safe use levels in food products.

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Xanthan gum: Safety evaluation by two-year feeding studies in rats and dogs and a three-generation reproduction study in rats

Cited by 22 publications

References 7 publications

Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections

Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections

Bacterial Polysaccharides: Production and Applications in Cosmetic Industry

An integrated approach to the safety assessment of food additives in early life

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