Montmorillonite

The Basics On Montmorillonite

What is Montmorillonite?

A type of clay that is a mix of bentonite and fuller’s earth.

What are other names for Montmorillonite?

MONTMORILLONITE and MONTMORILLONITE CLAY

What is Montmorillonite used for?

Montmorillonite clay’s structure consists of a large surface area composed of very small, negatively-charged particles. … Formulas with montmorillonite clay can help remove impurities from the skin’s surface by expanding facial pores and extracting the debris trapped within the skin.

How Montmorillonite is classified

Absorbent

Recommendations for using Montmorillonite during pregnancy and breastfeeding

Limited data suggests no known risk

 

Montmorillonite During Pregnancy

What we know about using Montmorillonite while pregnant or breastfeeding

Limited information available.

Calcium Silicate FDRL Inc. (1973) conducted a study in which adult, Dutchbelted female rabbits were artificially inseminated and received oral intubations of Calcium Silicate at doses of 250, 500, 750, 1000, 1250, 1500, and 1600 mg/kg on days 6 through 18 after insemination. On day 29, cesarean section was performed and the numbers of corpora lutea, implantation sites, resorption sites, and live and dead fetuses were recorded. Body weights of live pups were recorded. The urogenital tracts of the animals were examined in detail. All fetuses underwent detailed gross examination. Calcium Silicate administered at 1600 mg/kg to pregnant rabbits for 13 consecutive days had no clear discernible effect on nidation or on maternal or fetal survival. Skeletal or soft tissue abnormalities did not differ from the number occurring in control groups. Kaolin Groups of 12 Sprague-Dawley female rats were fed three diets: control diet, 20% Kaolin diet, or iron-supplemented 20% Kaolin diet. The diets were fed for 37 to 86 days, 69 to 85 days, and 96 to 117 days prior to fertilization. These same diets were fed for the duration of the gestation period. The animals fed SILICATES 87 the 20% Kaolin diet had significant reductions in hemoglobin, hematocrit, and RBC numbers, indicating maternal anemia. Significant reduction in the birth weight of the pups was observed. Animals fed the iron-supplemented diet maintained their hematocrit, hemoglobin, and RBC levels (Patterson and Staszak 1977). Magnesium Aluminum Silicate According to Sakai and Moriguchi (1975), “MAS has neither teratogenic nor had adverse effects on the mouse fetus.” MAS was administered at doses of 600, 3000, and 6000 mg/kg/day orally to pregnant mice (ICR-JCL) for 6 days on the 7th to 12th day of gestation. No significant differences between MASadministered and control groups were observed in body weight gain, gross lesions, implantations, resorbed or dead fetuses, or growth inhibition of live fetuses. Incidences of skeletal anomalies were significantly greater in MAS-exposed fetuses, but none resulted in skeletal malformation. Development, external differentiation, body weight gain, and behavior were normal in all offspring. Zeolite (Type A) Type A Zeolite containing 15.8% sodium 19.0% silicon, and 20.1% aluminum was tested for its teratogenic potential by Nolen and Dickerman (1983). Sprague-Dawley rats and New Zealand rabbits were utilized under the standard FDA Segment II protocol. Zeolite A in distilled water was given to rats by gavage at concentrations of 74 or 1600 mg/kg of body weight on days 6 to 15. Rabbits were given doses of 74, 345, and 1600 mg/kg of Zeolite A by oral gavage on days 6 to 18. Vehicle controls were included but no details were provided. Type A Zeolite produced no adverse effects on the dam, embryo, or fetus in either the rats or rabbits at any dose. Zeolite (Clinoptilolite) Pond and Yen (1983a) investigated whether Clinoptilolite offers protection against the toxic effect of long-term cadmium ingestion by examining the effects of long-term ingestion of Clinoptilolite on reproduction and on the postnatal development of the progeny. Four groups of female Sprague-Dawley rats were fed the following diets: control; control and Clinoptilolite; control plus cadmium; and control plus cadmium and Clinoptilolite. At 13 weeks, male rats were placed with the females for mating. The female reproductive performance was unaffected by any of the various diets. The supplemental level of Clinoptilolite resulted in reduced body weight during gestation; body weight at parturition and postpartum was similar for rats of all diet groups.

General safety info about Montmorillonite from CIR

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 ¬µm as possibly carcinogenic to humans, but fibers <5 ¬µm 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 ¬µm) 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) 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.

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Products where you might find Montmorillonite

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