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Fuller's Earth -
Medical Countermeasures Database

1. Name of Chemical Defense therapeutic agent/device

Fuller's earth

2. Chemical Defense therapeutic area(s)

    — including key possible uses

Fuller's earth is formulated into solutions, pastes for skin decontamination against chemical warfare agents.

3. Evidence-based medicine for Chemical Defense

    — including efficacy and safety

A. Summary

Structure

A porous colloidal clay. Contains an aluminum magnesium silicate. Fuller’s earth consists chiefly of hydrated aluminum silicates that contain metal ions such as magnesium, sodium, and calcium within their structure. Montmorillonite is the principal clay mineral in Fuller’s earth, but other minerals such as kaolinite, attapulgite, and palygorskite also occur and account for its variable chemical composition. Though similar in appearance to clay, fuller’s earth differs by being more fine-grained and by having a higher water content. It also crumbles into mud when mixed with water, so it has little natural plasticity. The substance is found in a wide range of natural colors, from brown or green to yellow and white. It is used as a physical barrier for prevention of dermal absorption of chemical warfare agents. It is also used as an oral decontamination against numerous toxins.

ChemIDplus. English fullers earth

Encyclopedia Britannica online. Fuller’s Earth, clay

Cosmetics Info. Fuller's Earth

Mechanism of action

Fuller’s Earth can be used to decontaminate skin after nerve agent and other exposure. Fuller's Earth resembles clay in texture and form, but it is actually a superabsorbent form of aluminum silicate. Mostly composed of silica, magnesium, iron, and aluminum, it has been used for centuries to absorb dirt and oil.

What is fullers earth? WiseGeek

Summary of clinical and non-clinical studies

Various formulations of Fuller’s Earth have been studied in clinical and non-clinical studies.

Chemical warfare (CW) agents may cause both conventional and chemical injuries. The effects of the two types of injuries may be reciprocal, leading to difficulties in assessing and treating such patients. Several aspects of the combined injury are discussed: increased exposure to CW agents following conventional trauma, owing to skin laceration or inability to use a gas mask (head, face or chest trauma); pathophysiological interactions between the two types of injuries; protection of medical personnel against CW intoxication; treatment limitations of personnel caused by their CW protection gear, when treating patients requiring urgent decontamination; and the influence of conventional trauma on the management of CW casualties. The Israel Defense Forces' recommendations for the treatment of combined injuries in a contaminated area include: a) airway maintenance, b) securing breathing and ventilation, c) circulation and hemorrhage control, d) antidote administration, e) decontamination with fuller's earth, f) dressing the wound, and g) evacuation to a noncontaminated area.

Berkenstadt H, Marganitt B, Atsmon J Combined chemical and conventional injuries--pathophysiological, diagnostic and therapeutic aspects. Isr J Med Sci. 1991; 27(11-12):623-6. [PubMed Citation]

B. Link to clinical studies

Adult

[Human hair locks.] ​Chemical warfare agents are an actual threat and victims' decontamination is a main concern when mass exposure occurs. Skin decontamination with current protocols has been widely documented, as well as surface decontamination. However, considering hair ability to trap chemicals in vapour phase, we investigated hair decontamination after exposure to sulphur mustard simulants methyl salicylate and 2-chloroethyl ethyl sulphide. Four decontamination protocols were tested on hair, combining showering and emergency decontamination (use of Fuller's earth or Reactive Skin Decontamination Lotion RSDL®). Both simulants were recovered from hair after treatment, but contents were significantly reduced (42-85% content allowance). Showering alone was the least efficient protocol. Concerning 2-chloroethyl ethyl sulphide, protocols did not display significant differences in decontamination efficacy. For MeS, use of emergency decontaminants significantly increased showering efficacy (10-20% rise), underlining their usefulness before thorough decontamination. Our results highlighted the need to extensively decontaminate hair after chemical exposure. Residual amounts after decontamination are challenging, as their release from hair could lead to health issues.

Spiandore M, Piram A, Lacoste A, Prevost P, Maloni P, Torre F, Asia L, Josse D, Doumenq P. Efficacy of scalp hair decontamination following exposure to vapours of sulphur mustard simulants 2-chloroethyl ethyl sulphide and methyl salicylate. Chem Biol Interact. 2017; 267:74-79. [PubMed Citation]

[Human hair locks.] In this work, our goals were to establish whether hair decontamination by showering one hour post-exposure to the highly toxic organophosphate nerve agent VX was effective, whether it required the addition of a detergent to water and, if it could be improved by using the adsorbent Fuller's Earth (FE) or the Reactive Skin Decontamination Lotion (RSDL) 30 min prior to showering. Hair exposure to VX and decontamination was performed by using an in vitro model. Hair showering led to 72% reduction of contamination. Addition of detergent to water slightly increased the decontamination effectiveness. Hair treatment with FE or RSDL improved the decontamination rate. Combination of FE use and showering, which yielded a decontamination factor of 41, was demonstrated to be the most effective hair decontamination procedure. Hair wiping after showering was shown to contribute to hair decontamination. Altogether, our results highlighted the importance of considering hair decontamination as an important part of body surface decontamination protocols.

Josse D, Wartelle J, Cruz C. Showering effectiveness for human hair decontamination of the nerve agent VX. Chem Biol Interact. 2015; 232:94-100. [PibMed citation]

C. Link to non-clinical (e.g., animal) studies

Adult animal studies

This report reviews the safety of Aluminum, Calcium, Lithium Magnesium, Lithium Magnesium Sodium, Magnesium Aluminum, Magnesium, Sodium Magnesium, and Zirconium Silicates, Magnesium Trisilicate, Attapulgite, Bentonite, Fuller's Earth, Hectorite, Kaolin, Montmorillonite, Pyrophyllite, and Zeolite as used in cosmetic formulations. The common aspect of all these claylike ingredients is that they contain silicon, oxygen, and one or more metals. Many silicates occur naturally and are mined; yet others are produced synthetically. Typical cosmetic uses of silicates include abrasive, opacifying agent, viscosity-increasing agent, anticaking agent, emulsion stabilizer, binder, and suspending agent. Clay silicates (silicates containing water in their structure) primarily function as adsorbents, opacifiers, and viscosity-increasing agents. Pyrophyllite is also used as a colorant. The International Agency for Research on Cancer has ruled Attapulgite fibers >5 microm as possibly carcinogenic to humans, but fibers <5 microm were not classified as to their carcinogenicity to humans. Likewise, Clinoptilolite, Phillipsite, Mordenite, Nonfibrous Japanese Zeolite, and synthetic Zeolites were not classified as to their carcinogenicity to humans. These ingredients are not significantly toxic in oral acute or short-term oral or parenteral toxicity studies in animals. Inhalation toxicity, however, is readily demonstrated in animals. Particle size, fibrogenicity, concentration, and mineral composition had the greatest effect on toxicity. Larger particle size and longer and wider fibers cause more adverse effects. Magnesium Aluminum Silicate was a weak primary skin irritant in rabbits and had no cumulative skin irritation in guinea pigs. No gross effects were reported in any of these studies. Sodium Magnesium Silicate had no primary skin irritation in rabbits and had no cumulative skin irritation in guinea pigs. Hectorite was nonirritating to the skin of rabbits in a Draize primary skin irritation study. Magnesium Aluminum Silicate and Sodium Magnesium Silicate caused minimal eye irritation in a Draize eye irritation test. Bentonite caused severe iritis after injection into the anterior chamber of the eyes of rabbits and when injected intralamellarly, widespread corneal infiltrates and retrocorneal membranes were recorded. In a primary eye irritation study in rabbits, Hectorite was moderately irritating without washing and practically nonirritating to the eye with a washout. Rats tolerated a single dose of Zeolite A without any adverse reaction in the eye. Calcium Silicate had no discernible effect on nidation or on maternal or fetal survival in rabbits. Magnesium Aluminum Silicate had neither a teratogenic nor adverse effects on the mouse fetus. Female rats receiving a 20% Kaolin diet exhibited maternal anemia but no significant reduction in birth weight of the pups was recorded. Type A Zeolite produced no adverse effects on the dam, embryo, or fetus in either rats or rabbits at any dose level. Clinoptilolite had no effect on female rat reproductive performance. These ingredients were not genotoxic in the Ames bacterial test system. In primary hepatocyte cultures, the addition of Attapulgite had no significant unscheduled DNA synthesis. Attapulgite did cause significant increases in unscheduled DNA synthesis in rat pleural mesothelial cells, but no significant increase in sister chromosome exchanges were seen. Zeolite particles (<10 microm) produced statistically significant increase in the percentage of aberrant metaphases in human peripheral blood lymphocytes and cells collected by peritoneal lavage from exposed mice. Topical application of Magnesium Aluminum Silicate to human skin daily for 1 week produced no adverse effects. Occupational exposure to mineral dusts has been studied extensively. Fibrosis and pneumoconiosis have been documented in workers involved in the mining and processing of Aluminum Silicate, Calcium Silicate, Zirconium Silicate, Fuller's Earth, Kaolin, Montmorillonite, Pyrophyllite, and Zeolite. The Cosmetic Ingredient Review (CIR. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the extensive pulmonary damage in humans was the result of direct occupational inhalation of the dusts and noted that lesions seen in animals were affected by particle size, fiber length, and concentration. The Panel considers that most of the formulations are not respirable and of the preparations that are respirable, the concentration of the ingredient is very low. Even so, the Panel considered that any spray containing these solids should be formulated to minimize their inhalation. With this admonition to the cosmetics industry, the CIR Expert Panel concluded that these ingredients are safe as currently used in cosmetic formulations. The Panel did note that the cosmetic ingredient, Talc, is a hydrated magnesium silicate. Because it has a unique crystalline structure that differs from ingredients addressed in this safety assessment, Talc is not included in this report.

Elmore AR; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of aluminum silicate, calcium silicate, magnesium aluminum silicate, magnesium silicate, magnesium trisilicate, sodium magnesium silicate, zirconium silicate, attapulgite, bentonite, Fuller's earth, hectorite, kaolin, lithium magnesium silicate, lithium magnesium sodium silicate, montmorillonite, pyrophyllite, and zeolite. Int J Toxicol. 2003;22 Suppl 1:37-102. Review

 

[Pig skin.] Research in skin decontamination and therapy of chemical warfare agents has been a difficult problem due to the simultaneous requirement of rapid action and non-aggressive behaviour. The aim of this study was to compare the performance of two decontaminating systems: the Canadian Reactive Skin Decontaminant Lotion (RSDL) and the Fuller's Earth (FE). The experiment was conducted with domestic swine, as a good model for extrapolation to human skin. RSDL and FE were tested against sulphur mustard (SM), a powerful vesicant, and VX, a potent and persistent cholinesterase inhibitor. When used 5 min after contamination, the results clearly showed that both systems were active against SM (10.1 mg/cm(2)) and VX (0.06 mg/cm(2)). The potency of the RSDL/sponge was statistically better than FE against skin injury induced by SM, observed 3 days post-exposure. RSDL was rather more efficient than FE in reducing the formation of perinuclear vacuoles and inflammation processes in the epidermis and dermis. Against a severe inhibition (67%) of plasmatic cholinesterases induced by VX poisoning, the potencies of the RSDL/sponge and FE were similar. Both systems completely prevented cholinesterase inhibition, which indirectly indicates a prevention of toxic absorption through the skin.

Taysse L, Daulon S, Delamanche S, Bellier B, Breton P. Skin decontamination of mustards and organophosphates: comparative efficiency of RSDL and Fuller's earth in domestic swine. Hum Exp Toxicol. 2007;26(2):135-41 [PubMed Citation]

Using the hairless mouse screening model the aim of this study was to assess two skin decontaminating systems: Fuller's earth (FE) and Reactive Skin Decontamination Lotion (RSDL) against two extremely toxic chemical warfare agents that represent a special percutaneous hazard, sulphur mustard (SM) and O-ethyl-S-(2[di-isopropylamino]ethyl)methyl-phosphonothioate (VX). Five minutes after being exposed on the back to either 2 µL of neat sulphur mustard or 50 µg.kg(-1) of diluted VX, mice were decontaminated. Both systems were able to reduce blisters 3 days after SM exposure. However, RSDL was found to be more efficient than FE in reducing the necrosis of the epidermis and erosion. In the case of VX exposure, RSDL, whatever the ratio of decontaminant to toxicant used (RSDL 10, 20, 50), was not able to sufficiently prevent the inhibition of plasma cholinesterases taken as a surrogate marker of exposure and toxicity. Only FE reduced significantly the ChE inhibition. Some of these observations are different from our previous results obtained in domestic swine and these changes are thus discussed in the perspective of using SKH-1 hairless mice for the initial in vivo screening of decontaminants.

Taysse L, Dorandeu F, Daulon S, Foquin A, Perrier N, Lallement G, Breton P. Cutaneous challenge with chemical warfare agents in the SKH-1 hairless mouse (II): effects of some currently used skin decontaminants (RSDL and Fuller's earth) against liquid sulphur mustard and VX exposure. Hum Exp Toxicol. 2011; 30(6):491-8. [PubMed Citation]

Other non-clinical studies

Human non-clinical studies

[Human skin samples] The decontamination efficacy of four commercially available skin decontamination products following exposure to the nerve agent VX was evaluated in　vitro utilizing a diffusion cell and dermatomed human skin. The products included were Reactive Skin Decontamination Lotion (RSDL), the Swedish decontamination powder 104 (PS104), the absorbent Fuller's Earth and the aqueous solution alldecontMED. In addition, various decontamination procedures were assessed to further investigate important mechanisms involved in the specific products, e.g. decontamination removal from skin, physical removal by sponge swabbing and activation of degradation mechanisms. The efficacy of each decontamination product was evaluated 5 or 30　min after dermal application of VX (neat or diluted to 20% in water). The RSDL-lotion was superior in reducing the penetration of VX through human skin, both when exposed as neat agent and when diluted to 20% in water. Swabbing with the RSDL-sponge during 2　min revealed decreased efficacy compared to applying the RSDL-lotion directly on the skin for 30　min. Decontamination with Fuller's Earth and alldecontMED significantly reduced the penetration of neat concentration of VX through human skin. PS104-powder was insufficient for decontamination of VX at both time-points, independently of the skin contact time of PS104. The PS104-slurry (a mixture of PS104-powder and water), slightly improved the decontamination efficacy. Comparing the time-points for initiated decontamination revealed less penetrated VX for RSDL and Fuller's Earth when decontamination was initiated after 5　min compared to 30　min post-exposure, while alldecontMED displayed similar efficacy at both time-points. Decontamination by washing with water only resulted in a significant reduction of penetrated VX when washing was performed 5　min after exposure, but not when decontamination was delayed to 30　min post-exposure of neat VX. In conclusion, early initiated decontamination with the RSDL-lotion, containing both absorption and degrading properties, allowed to act on skin for 30　min was superior in preventing VX from penetrating human skin. Adding water during decontamination resulted in increased penetration of neat VX, however, water in the decontaminant removal process did not influence the decontamination efficacy. From our study on commercially available decontaminants, it is recommended that future product developments should include both strong absorbents and efficient nerve agent degrading components.

Thors L, Koch M, Wigenstam E, Koch B, Hägglund L, Bucht A. Comparison of skin decontamination efficacy of commercial decontamination products following exposure to VX on human skin.Chem Biol Interact. 2017 Aug 1;273:82-89. [PubMed Citation]

[Human and pig-ear skin samples.] The aim of this study was to evaluate the use of an in vitro skin diffusion cell system as a model for assessing decontaminants against the chemical warfare agent sulphur mustard (SM). The in vitro absorption rates of SM through heat-separated human (157 +/- 66 microg cm(-2) h(-1)) and pig-ear (411 +/- 175 microg cm(-2) h(-1)) epidermal membranes were in agreement with previous in vivo studies that quoted skin absorption rates of 150 and 366 microg cm(-2) h(-1), respectively. Decontaminants (fuller's earth, Ambergard and BDH spillage granules) were ranked in order of effectiveness by measuring the skin absorption rates and the percentage of applied dose of SM that penetrated human and pig-ear epidermal membranes. The effectiveness of fuller's earth measured in this in vitro study using human epidermal membranes was in agreement with a previous in vivo human volunteer study. Similarly, the effectiveness of fuller's earth and Ambergard measured in vitro with pig-ear epidermal membranes was in agreement with a previous in vivo study conducted on rats. However, there was complete disparity in the ranking of decontaminants between human and pig-ear epidermal membranes measured in vitro. Thus, although pig-ear skin may be a relatively good model for predicting the human skin absorption of SM, it is a poor model for testing decontamination systems. The results of this study further validate the use of Franz-type glass diffusion cells containing human epidermal membranes as a model for predicting in vivo human skin absorption.

Chilcott RP, Jenner J, Hotchkiss SA, Rice P. . In vitro skin absorption and decontamination of sulphur mustard: comparison of human and pig-ear skin. J Appl Toxicol. 2001 Jul-Aug;21(4):279-83. [PubMed Citation]

 

Animal in vitro studies

[Pig skin samples.] Industrial accidents, wars and terrorist threats are potential sources of skin contamination by highly toxic chemical warfare agents and manufacturing compounds. We have compared the time-dependent adsorption capacity and decontamination efficiency of fuller's earth (FE) for four different formulations for the molecular tracer, 4-cyanophenol (4-CP), in vitro and ex vivo using water decontamination as standard. The adsorption capacity of FE was assessed in vitro for 4-CP aqueous solutions whereas decontamination efficiency was investigated ex vivo by tracking porcine skin 4-CP content using attenuated total reflectance Fourier transform infrared spectroscopy. Decontamination was performed on short time, exposed porcine skin to 4-CP by application of FE: (1) as free powder; (2) loaded on adhesive tape; (3) on powdered glove; or (4) in suspension. Removal rate of 4-CP from aqueous solutions correlates with the amount of FE and its contact time. Decontamination efficiency estimated by the percentage of 4-CP recovery from contaminated porcine skin, achieved 54% with water, ranged between ~60 and 70% with dry FE and reached ~90% with FE suspension. Successful decontamination of the FE suspension, enabling a dramatic reduction of skin contamination after a brief exposure scenario, appears to be rapid, reliable and should be formulated in a new device ready to use for self-application.
Roul A, Le CA, Gustin MP, Clavaud E, Verrier B, Pirot F, Falson F.Comparison of four different fuller's earth formulations in skin decontamination. J Appl Toxicol. 2017 Jul 26.　 [Epub ahead of print] [PubMed Citation]

[Pig ear skin samples.] Skin contamination is one of the most probable risks following major nuclear or radiological incidents. However, accidents involving skin contamination with radionuclides may occur in the nuclear industry, in research laboratories and in nuclear medicine departments. This work aims to measure the penetration of the radiological contaminant Americium (241Am) in fresh and frozen skin and to evaluate the distribution of the contamination in the skin. Decontamination tests were performed using water, Fuller's earth and diethylene triamine pentaacetic acid (DTPA), which is the recommended treatment in case of skin contamination with actinides such as plutonium or americium. To assess these parameters, we used the Franz cell diffusion system with full-thickness skin obtained from pigs' ears, representative of human skin. Solutions of 241Am were deposited on the skin samples. The radioactivity content in each compartment and skin layers was measured after 24 h by liquid scintillation counting and alpha spectrophotometry. The Am cutaneous penetration to the receiver compartment is almost negligible in fresh and frozen skin. Multiple washings with water and DTPA recovered about 90% of the initial activity. The rest remains fixed mainly in the stratum corneum. Traces of activity were detected within the epidermis and dermis which is fixed and not accessible to the decontamination.

Tazrart A, Bolzinger MA, Moureau A, Molina T, Coudert S, Angulo JF, Briancon S, Griffiths NM. Penetration and decontamination of americium-241 ex vivo using fresh and frozen pig skin. Chem Biol Interact. 2017;267:40-47. [PubMed Citation]

[Pig skin samples.] Previous studies have demonstrated that haemostatic products with an absorptive mechanism of action retain their clotting efficiency in the presence of toxic materials and are effective in decontaminating chemical warfare (CW) agents when applied to normal, intact skin. The purpose of this in vitro study was to assess three candidate haemostatic products for effectiveness in the decontamination of superficially damaged porcine skin exposed to the radiolabelled CW agents, soman (GD), VX and sulphur mustard (HD). Controlled physical damage (removal of the upper 100 μm skin layer) resulted in a significant enhancement of the dermal absorption of all three CW agents. Of the haemostatic products assessed, WoundStat™ was consistently the most effective, being equivalent in performance to a standard military decontaminant (fuller's earth). These data suggest that judicious application of haemostatic products to wounds contaminated with CW agents may be a viable option for the clinical management of casualties presenting with contaminated, haemorrhaging injuries. Further studies using a relevant animal model are required to confirm the potential clinical efficacy of WoundStat™ for treating wounds contaminated with CW agents.

Lydon HL, Hall CA, Dalton CH, Chipman JK, Graham JS, Chilcott RP. Development of haemostatic decontaminants for treatment of wounds contaminated with chemical warfare agents. 3: Evaluation of in vitro topical decontamination efficacy using damaged skin. J Appl Toxicol. 2017; 37(8):976-984. [PubMed Citation]

[Pig ear skin samples.] Organophosphorus compounds (OP), which mainly penetrate via the percutaneous pathway, represent a threat for both military and civilians. Body surface decontamination is vital to prevent victims poisoning. The development of a cost-effective formulation, which could be efficient and easy to handle in case of mass contamination, is therefore crucial. Metal oxides nanoparticles, due their large surface areas and the large amount of highly reactive sites, present high reactivity towards OP. First, this study aimed at evaluating the reaction of CeO2 nanoparticles, synthetized by microwave path and calcined at 500 or 600 °C, with Paraoxon (POX) in aqueous solution. Results showed that both nanoparticles degraded 60%-70% of POX. CeO2 calcined at 500 °C, owing to its larger specific area, was the most effective. Moreover, the degradation was significantly increased under Ultra-Violet irradiation (initial degradation rate doubled). Then, skin decontamination was studied in vitro using the Franz cell method with pig-ear skin samples. CeO2 powder and an aqueous suspension of CeO2 (CeO2-W) were applied 1 h after POX exposure. The efficiency of decontamination, including removal and/or degradation of POX, was compared to Fuller's earth (FE) and RSDL lotion which are, currently, the most efficient systems for skin decontamination. CeO2-W and RSDL were the most efficient to remove POX from the skin surface and decrease skin absorption by 6.4 compared to the control not decontaminated. FE reduced significantly (twice) the absorbed fraction of POX, contrarily to CeO2 powder. Considering only the degradation rate of POX, the products ranged in the order CeO2 > RSDL > CeO2-W > FE (no degradation). This study showed that CeO2 nanoparticles are a promising material for skin decontamination of OP if formulated as a dispersion able to remove POX like CeO2-W and to degrade it as CeO2 powder.

Salerno A, Devers T, Bolzinger MA, Pelletier J, Josse D, Briançon S. In vitro skin decontamination of the organophosphorus pesticide Paraoxon with nanometric cerium oxide CeO2. Chem Biol Interact. 2017; 267:57-66. [PubMed Citation]

[Pig skin samples.] The risk of penetrating, traumatic injury occurring in a chemically contaminated environment cannot be discounted. Should a traumatic injury be contaminated with a chemical warfare (CW) agent, it is likely that standard haemostatic treatment options would be complicated by the need to decontaminate the wound milieu. Thus, there is a need to develop haemostatic products that can simultaneously arrest haemorrhage and decontaminate CW agents. The purpose of this study was to evaluate a number of candidate hemostats for efficacy as skin decontaminants against three CW agents (soman, VX and sulphur mustard) using an in vitro diffusion cell containing undamaged pig skin. One haemostatic product (WoundStat™) was shown to be as effective as the standard military decontaminants Fuller's earth and M291 for the decontamination of all three CW agents. The most effective haemostatic agents were powder-based and use fluid absorption as a mechanism of action to sequester CW agent (akin to the decontaminant Fuller's earth). The envisaged use of haemostatic decontaminants would be to decontaminate from within wounds and from damaged skin. Therefore, WoundStat™ should be subject to further evaluation using an in vitro model of damaged skin.

Dalton CH, Hall CA, Lydon HL, Chipman JK, Graham JS, Jenner J, Chilcott RP Development of haemostatic decontaminants for the treatment of wounds contaminated with chemical warfare agents. 2: evaluation of in vitro topical decontamination efficacy using undamaged skin. J Appl Toxicol. 2015; 35(5):543-50. [PubMed Citation]

[Pig ear skin samples.] This study aimed at developing innovative systems for skin decontamination. Pickering emulsions, i.e. solid-stabilized emulsions, containing silica (S-PE) or Fuller's earth (FE-PE) were formulated. Their efficiency for skin decontamination was evaluated, in vitro, 45min after an exposure to VX, one of the most highly toxic chemical warfare agents. Pickering emulsions were compared to FE (FE-W) and silica (S-W) aqueous suspensions. PE containing an oil with a similar hydrophobicity to VX should promote its extraction. All the formulations reduced significantly the amount of VX quantified on and into the skin compared to the control. Wiping the skin surface with a pad already allowed removing more than half of VX. FE-W was the less efficient (85% of VX removed). The other formulations (FE-PE, S-PE and S-W) resulted in more than 90% of the quantity of VX removed. The charge of particles was the most influential factor. The low pH of formulations containing silica favored electrostatic interactions of VX with particles explaining the better elimination from the skin surface. Formulations containing FE had basic pH, and weak interactions with VX did not improve the skin decontamination. However, these low interactions between VX and FE promote the transfer of VX into the oil droplets in the FE-PE.

Salerno A, Bolzinger MA, Rolland P, Chevalier Y, Josse D, Briançon S. Pickering emulsions for skin decontamination. Toxicol In Vitro. 2016;34:45-54. [PubMed Citation]

[Pig ear skin and pig skull roof same samples.] The chemical warfare agents such as VX represent a threat for both military and civilians, which involves an immediate need of effective decontamination systems. Since human scalp is usually unprotected compared to other body regions covered with clothes, it could be a preferential site of exposure in case of terrorist acts. The purpose of this study was to determine if skin decontamination could be efficient when performed more than 1h after exposure. In addition, the impact of hairs in skin contamination was investigated. By using in vitro skin models, we demonstrated that about 75% of the applied quantity of VX was recovered on the skin surface 2h after skin exposition, which means that it is worth decontaminating even if contamination occurred 2h before. The stratum corneum reservoir for VX was quickly established and persistent. In addition, the presence of hairs modified the percutaneous penetration of the nerve agent by binding of VX to hairs. Hair shaft has thus to be taken into account in the decontamination process. Reactive Skin Decontamination Lotion (RSDL) and Fuller's Earth (FE) were active in the skin decontamination 45min post-exposure, but RSDL was more efficient in reducing the amount of VX either in the skin or in the hair.

Rolland P, Bolzinger MA, Cruz C, Josse D, Briançon S Hairy skin exposure to VX in vitro: effectiveness of delayed decontamination. Toxicol In Vitro. 2013; 27(1):358-66.

[Pig skin samples.] Rapid decontamination is vital to alleviate adverse health effects following dermal exposure to hazardous materials. There is an abundance of materials and products which can be utilised to remove hazardous materials from the skin. In this study, a total of 15 products were evaluated, 10 of which were commercial or military products and five were novel (molecular imprinted) polymers. The efficacies of these products were evaluated against a 10 µl droplet of (14)C-methyl salicylate applied to the surface of porcine skin mounted on static diffusion cells. The current UK military decontaminant (Fuller's earth) performed well, retaining 83% of the dose over 24 h and served as a benchmark to compare with the other test products. The five most effective test products were Fuller's earth (the current UK military decontaminant), Fast-Act® and three novel polymers [based on itaconic acid, 2-trifluoromethylacrylic acid and N,N-methylenebis(acrylamide)]. Five products (medical moist-free wipes, 5% FloraFree™ solution, normal baby wipes, baby wipes for sensitive skin and Diphotérine™) enhanced the dermal absorption of (14)C-methyl salicylate. Further work is required to establish the performance of the most effective products identified in this study against chemical warfare agents.

Matar H, Guerreiro A, Piletsky SA, Price SC, Chilcott RP. Preliminary evaluation of military, commercial and novel skin decontamination products against a chemical warfare agent simulant (methyl salicylate). Cutan Ocul Toxicol. 2016; 35(2):137-44.[PubMed Citation]

Non-clinical reviews

No data available at this time.

 

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4. Pharmacokinetic and toxicokinetics data

    — including children-, pregnancy-, geriatric-, and obesity-related data

No data available at this time.

 

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5. Current FDA/EUA approved indications and dosing

    — including children-, pregnancy-, geriatric-, and obesity-related data, and Emergency Use Authorization (EUA)

No data available at this time.

 

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6. Current available formulations/shelf life

Slurry, paste, or other form of application to skin and clothing for decontamination.

Fuller’s Earth Cream is a buff colored cream which is supplied in 60 g packs.

Fullers Earth Cream (Drugs.com)

Shelf life 36 months unopened.

Special precautions for storage: Do not store above 25°C

Fuller's Earth Cream (electronic Medicines Compendium (eMC))

 

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7. Current off label utilization and dosing

    — including children-, pregnancy-, geriatric-, and obesity-related data

No data available at this time.

 

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8. Route of Administration/Monitoring

Applied to skin using a cream based product.

Fullers Earth Cream (Drugs.com)

 

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9. Adverse effects

Fertility, pregnancy and lactation

No adverse effects are considered likely when the product is used in either of the above conditions

Fuller's Earth Cream (electronic Medicines Compendium (eMC))

 

Potential Health Effects

Eye: May cause eye irritation. Skin: May cause skin irritation. Ingestion: The toxicological properties of this substance have not been fully investigated. Inhalation: May cause respiratory tract irritation. The toxicological properties of this substance have not been fully investigated Chronic: No information found.

Fuller's Earth MSDS (Fisher Scientific)

Fullers Earth Cream contains refined arachis oil (peanut oil). If you are allergic to peanuts or soya do not use this product. It also contains wool alcohols (lanolin) which may cause local skin reactions (e.g. contact dermatitis).

This product is a non-combustible, chemically inert mineral. This mineral sample contains naturally-occurring crystalline silica as quartz. Prolonged overexposure to respirable crystalline silica may cause lung disease (silicosis).

Granular Absorbent MSDS (Oil Dri Corporation of America)

 

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10. Contraindication(s)

Eye Contact: Check for and remove any contact lenses. Do not use an eye ointment.

Hazardous in case of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant).

Fuller's Earth MSDS (ScienceLab.com)

 

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11. Clinical studies in progress

    — including relevant ones and any others highlighting possible adverse effects and other effects/issues

No data available at this time.

 

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12. Non-clinical studies in progress

    — including relevant ones and any others highlighting possible adverse effects and other effects/issues

No data available at this time.

 

13. Needed studies for Chemical Defense clinical indication

    — including pharmacokinetics, safety, efficacy, pregnancy, breastfeeding, and review panel recommendations

No data available at this time.

 

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14. Needed studies for non Chemical Defense clinical indications

    — including review panel recommendations

No data available at this time.

 

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15. Study-related ethical concerns

    — including review panel recommendations

No data available at this time.

 

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16. Global regulatory status

U.S. Silica Hydrated (Amorphous Opaline Silica): PEL - 80 mg/m³ / % SiO2
Fullers Earth: PEL - 15 mg/m³ TWA (total dust); PEL - 5 mg/m³ TWA (respirable fraction)
Bentonite: PEL - 15 mg/m³ TWA (total dust); PEL - 5 mg/m³ TWA (respirable fraction)
Quartz (respirable <1%): PEL - 10 mg/m³/%Si02+2 TWA; TLV - 0.025 mg/m³ TWA.

Granular Absorbent MSDS (Oil Dri Corporation of America)

 

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17. Other potentially useful information

Fuller’s Earth was used in laundries for removing oil and grease from heavily soiled dungarees, work gear and the like. Fuller’s Earth was very effective for scouring and fulling as it is far less gritty. Indeed Fuller’s Earth is better than soap or solvents for cleaning heavily oil-soiled textiles, such as dirty mats from motor cars. It is now known that it helps to prevent redeposition of soil when present in a complex household laundry detergent. Fuller’s Earth was mainly used at that time as an antidote to poison due to its superb adsorption properties. Including food poisoning and for the staunching of blood. Other uses included – a remedy for gastric disorders and diarrheas. 　Fuller’s Earth tones up the skin. Improves the complexion. Smoothes out wrinkles. It has a softening and preservation action upon skin of hands and face. Is tender to all skin types. It is very effective in treating oily skin as a deep pore cleanser to draw out hidden oils and grime. 　In earlier times and mainly during World War 2 sore and inflamed feet were soothed in a dispersion of Fuller’s Earth in water. Research during the war times established that Lewisite poison gas blisters healed rapidly when bandages containing Fuller’s earth powder were applied. To remove stains or spots of DNOC (dinitroorthocresol), the agricultural spraying poison, Fuller’s Earth should be applied as a paste, allowed to dry and then brushed off, according to official advice. Another way in which Fuller’s Earth is applied to the skin is a hot plaster for drawing pus and reducing inflammation. Fuller’s Earth was used as a styptic; used in preventing dermatitis in dye houses by dusting onto the face after being given a base coating of cream. There are some accounts of Fuller’s Earth power also being used in the manufacture of soaps used for cleaning clothes in saline water.

　About Fuller’s Earth (HRP Industries)

Bentonite, a clay with numerous industrial and consumer applications, is mined and processed in many countries of the world. Its many beneficial uses also create the potential for widespread occupational and consumer exposure. The available studies on toxicity and epidemiology indicate that the principal exposure pathway of concern is inhalation of respirable dust by occupationally exposed cohorts. Bentonite itself is probably not more toxic than any other particulate not otherwise regulated and is not classified as a carcinogen by any regulatory or advisory body, but some bentonite may contain variable amounts of respirable crystalline silica, a recognized human carcinogen. Therefore, prudent management and adherence to occupational exposure limits is appropriate. This review summarizes the literature available on production, applications, exposure, toxicity, and epidemiology of bentonite and identifies data gaps and limitations.

Maxim LD, Niebo R, McConnell EE. Bentonite toxicology and epidemiology - a review. Inhal Toxicol. 2016; 28(13):591-617. [PubMed Citation]

The name comes from its historic use in refining wool, when a craftsman, called a "fuller," would apply the clay-like substance to wool to remove dirt and oil before the cloth was completed. The clay is a byproduct of the metamorphosis of certain rocks and minerals. Some of the largest deposits result from the slow erosion of feldspar, a common mineral. It is often a byproduct of the gradual metamorphosis in volcanic glass. The United States is a major producer of most grades and forms of the clay, as are Japan, England, and Mexico. In modern times, fuller's earth is used as an effective absorbent product and is often found as a component of kitty litter. It is also used in filters, household cleaners, and stain removers for its unique ability to draw oil out of other substances. Automotive or repair garages often keep the product on hand for fast clean up of oil spills. It is also a major part of the refining process for edible oils, as can leach impurities from mineral, vegetable, or animal oil sources.

What is Fuller's Earth? (WiseGeek)

Original use was in the fulling of raw fibers. It is now utilized in a number of industries, mostly to make use of the natural absorbent properties in products sold as absorbents or filters. Examples:

• Decontamination of the clothing and equipment of servicemen and responders.
• Cleaning agent, e.g., to clean marble.
• Commercial cat litter.
• Cosmetic products and to treat acne and other skin problems.
• Special effects by the film industry and as "dirt" applied to people and clothing.

Fuller’s Earth (Wikipedia)

Herbicide poisoning is most common method of suicide in India and it is associated with high morbidity and mortality. Among different herbicidal poisonings the most predominantly found poisonings are paraquat and glyphosate. These compounds are highly toxic and their poisonings require proper management techniques. High fatality is seen in these cases which are mainly due to its inherent toxicity and lack of effective treatment. Common symptoms of these poisonings includes gastrointestinal corrosive effects with mouth and throat, epigastric pain and dysphagia, acid-base imbalance, pulmonary edema, shock and arrhythmia. Long term health effects include pulmonary fibrosis, renal failure, hepatic failure, heart failure, multi-organ failure or death. No proven antidote exists for these poisonings. So the treatment is mainly supportive. Initially gastric lavage or whole-gut irrigation using adsorbents such as Fuller's earth, bentonite or activated charcoal is recommended. In case of renal failure hemodialysis or hemoperfusion may be considered. However novel approaches like treatment with N-acetylcysteine, vitamin C, vitamin E, cyclophosphamide may also be helpful.

Cherukuri H, Pramoda K, Rohini D, Thunga G, Vijaynarayana K, Sreedharan N, Varma M, Pandit V. Demographics, clinical characteristics and management of herbicide poisoning in tertiary care hospital. Toxicol Int. 2014; 21(2):209-13. [PubMEd citation]

 

OBJECTIVE: To observe the therapeutic effects of gastric lavage with fuller earth combined with Qingyi II catharsis in treatment of oral paraquat poisoning in rabbits. METHODS: Thirty healthy adult Japanese white rabbits were randomly divided into five groups: namely control group, model group, gastric lavage group (lavage of 10% fuller earth suspension), catharsis group (Qingyi II catharsis), and combination group (10 minutes after gastric lavage of fuller earth suspension liquid, giving Qingyi II for catharsis), with 6 rabbits in each group. All groups were challenged with paraquat (100 mg/kg) diluted to 5 mL with normal saline by lavage to reproduce the model of acute poisoning, while the control group was given 5 mL of normal saline instead. Each treatment group was treated accordingly at 1 hour after gavages of paraquat, and treatment continued for 3 days. The animal survival rate was observed. Venous blood samples were collected from ear marginal vein to determine the plasma concentration of paraquat by ultraviolet spectrophotometer at 1, 2, 4, 8 and 24 hours after the poisoning. The animals were sacrificed by intravenous air injection on the 8th day after the poisoning, and the right lower lobe of lung was harvested to observe the lung tissue pathological changes with hematoxylin-eosin (HE) staining. RESULTS: (1) Survival rate: the surviving rate of the combination group (6 rabbits) was higher than that of gastric lavage group (5 rabbits), catharsis group (2 rabbits) and model group (0 rabbit) on the 2nd day with statistically significant difference (P < 0.001). The survival rate on the 7th day in combination group (5 rabbits) was higher than that of gastric lavage group (3 rabbits), and catharsis group (0 rabbit ) with statistically significant difference (P = 0.003). (2) Plasma concentrations of paraquat: plasma paraquat concentration in all groups peaked at 2 hours after intoxication, and its levels in the gastric lavage, catharsis and combination groups were significantly lower than that of the model group ( mg/L: 1.830 ± 0.068, 1.890 ± 0.048, 1.800 ± 0.052 vs. 1.960 ± 0.063, all P < 0.01). As the time prolonged, the plasma concentration of paraquat was lowest in combination group than that of gastric lavage group and catharsis group (all P < 0.01). Gastric lavage and catharsis had interaction at 4 hours in combination group [F = 5.194, P = 0.034; the concentrations of paraquat (mg/L) was 0.670 ± 0.057 vs. 1.010 ± 0.018, 1.210 ± 0.052]. (3) Lung histopathology: obvious expansion and hyperemia of the alveolar capillary, widened alveolar septum, a large number of inflammatory cell infiltrations were observed in model group and catharsis group. Lung histopathology was more improved in combination group and gastric lavage group, and it was improved more obviously in combination group than that in gastric lavage group. CONCLUSIONS: Early start of gastric lavage with fuller earth combined with Qingyi II catharsis, can reduce the animal plasma concentrations of paraquat in oral paraquat poisoning rabbits. At the same time, it can alleviate the degree of lung injury and significantly improve survival rates compared with the single gastric lavage or catharsis alone. Gastric lavage with fuller earth combined with Qingyi II catharsis can improve the prognosis of animal synergistically

Lu Y, Zhou M, Hu J, Li J. [Therapeutic effects of gastric lavage with fuller earth combined with QingyiII catharsis in treatment of oral paraquat poisoning in rabbits]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015; 27(4):250-3.[PubMed Citation].

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18. Publications

Berkenstadt H, Marganitt B, Atsmon J Combined chemical and conventional injuries--pathophysiological, diagnostic and therapeutic aspects. Isr J Med Sci. 1991; 27(11-12):623-6.[PubMed Citation]

Cherukuri H, Pramoda K, Rohini D, Thunga G, Vijaynarayana K, Sreedharan N, Varma M, Pandit V. Demographics, clinical characteristics and management of herbicide poisoning in tertiary care hospital. Toxicol Int. 2014; 21(2):209-13. [PubMed Citation]

Chilcott RP, Jenner J, Hotchkiss SA, Rice P. . In vitro skin absorption and decontamination of sulphur mustard: comparison of human and pig-ear skin. J Appl Toxicol. 2001 Jul-Aug;21(4):279-83. . [PubMed Citation]

Dalton CH, Hall CA, Lydon HL, Chipman JK, Graham JS, Jenner J, Chilcott RP Development of haemostatic decontaminants for the treatment of wounds contaminated with chemical warfare agents. 2: evaluation of in vitro topical decontamination efficacy using undamaged skin. J Appl Toxicol. 2015; 35(5):543-50. [PubMed Citation]

Elmore AR; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of aluminum silicate, calcium silicate, magnesium aluminum silicate, magnesium silicate, magnesium trisilicate, sodium magnesium silicate, zirconium silicate, attapulgite, bentonite, Fuller's earth, hectorite, kaolin, lithium magnesium silicate, lithium magnesium sodium silicate, montmorillonite, pyrophyllite, and zeolite. Int J Toxicol. 2003;22 Suppl 1:37-102. Review. [PubMed Citation].

Josse D, Wartelle J, Cruz C. Showering effectiveness for human hair decontamination of the nerve agent VX. Chem Biol Interact. 2015; 232:94-100. .[PubMed Citation].

Lu Y, Zhou M, Hu J, Li J. [Therapeutic effects of gastric lavage with fuller earth combined with QingyiII catharsis in treatment of oral paraquat poisoning in rabbits]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015; 27(4):250-3.[PubMed Citation].

Lydon HL, Hall CA, Dalton CH, Chipman JK, Graham JS, Chilcott RP. Development of haemostatic decontaminants for treatment of wounds contaminated with chemical warfare agents. 3: Evaluation of in vitro topical decontamination efficacy using damaged skin. J Appl Toxicol. 2017; 37(8):976-984. [PubMed Citation]

Matar H, Guerreiro A, Piletsky SA, Price SC, Chilcott RP. Preliminary evaluation of military, commercial and novel skin decontamination products against a chemical warfare agent simulant (methyl salicylate). Cutan Ocul Toxicol. 2016; 35(2):137-44.[PubMed Citation]

Maxim LD, Niebo R, McConnell EE. Bentonite toxicology and epidemiology - a review.
Inhal Toxicol. 2016; 28(13):591-617. [PubMed Citation]

Rolland P, Bolzinger MA, Cruz C, Josse D, Briançon S Hairy skin exposure to VX in vitro: effectiveness of delayed decontamination. Toxicol In Vitro. 2013; 27(1):358-66. [PubMed Citation]

Roul A, Le CA, Gustin MP, Clavaud E, Verrier B, Pirot F, Falson F.Comparison of four different fuller's earth formulations in skin decontamination. J Appl Toxicol. 2017 Jul 26.　 [Epub ahead of print] [PubMed Citation]

Salerno A, Bolzinger MA, Rolland P, Chevalier Y, Josse D, Briançon S. Pickering emulsions for skin decontamination. Toxicol In Vitro. 2016;;34:45-54. [PubMed Citation]

Salerno A, Devers T, Bolzinger MA, Pelletier J, Josse D, Briançon S. In vitro skin decontamination of the organophosphorus pesticide Paraoxon with nanometric cerium oxide CeO2. Chem Biol Interact. 2017; 267:57-66. [PubMed Citation]

Spiandore M, Piram A, Lacoste A, Prevost P, Maloni P, Torre F, Asia L, Josse D, Doumenq P. Efficacy of scalp hair decontamination following exposure to vapours of sulphur mustard simulants 2-chloroethyl ethyl sulphide and methyl salicylate.
Chem Biol Interact. 2017; 267:74-79. [PubMed Citation]

Taysse L, Daulon S, Delamanche S, Bellier B, Breton P. Skin decontamination of mustards and organophosphates: comparative efficiency of RSDL and Fuller's earth in domestic swine. Hum Exp Toxicol. 2007;26(2):135-41 [PubMed Citation]

Taysse L, Dorandeu F, Daulon S, Foquin A, Perrier N, Lallement G, Breton P. Cutaneous challenge with chemical warfare agents in the SKH-1 hairless mouse (II): effects of some currently used skin decontaminants (RSDL and Fuller's earth) against liquid sulphur mustard and VX exposure. Hum Exp Toxicol. 2011; 30(6):491-8. [PubMed Citation]

Tazrart A, Bolzinger MA, Moureau A, Molina T, Coudert S, Angulo JF, Briancon S, Griffiths NM. Penetration and decontamination of americium-241 ex vivo using fresh and frozen pig skin. Chem Biol Interact. 2017;267:40-47. [PubMed Citation]

Thors L, Koch M, Wigenstam E, Koch B, Hägglund L, Bucht A. Comparison of skin decontamination efficacy of commercial decontamination products following exposure to VX on human skin.Chem Biol Interact. 2017 Aug 1;273:82-89. [PubMed Citation]

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19. Web sites

English fullers earth (ChemIDplus)

About Fuller’s Earth (Cosmetics Info web site)

Fuller’s earth clay (Encyclopedia Britannica online)

What is Fuller’s Earth? (WiseGeek.org)

NIH CounterACT Program (HHS/NIH)

NIH RePORTER (HHS/NIH)

ClinicalTrials.gov (HHS/NIH)

PubMed (HHS/NIH)

DailyMed (HHS/NIH)

Record last updated 9/14/2017