Bentonite
Grundinformationen
- CAS
110070-78-5- Standard-SMILES
O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.[Al+3].[Al+3].[O-2].[O-2].[O-2]- InChIKey
GUJOJGAPFQRJSV-UHFFFAOYSA-N- Summenformel
- Al2H2O12Si4
- Durchschnittliche Molmasse
- 360,31 g/mol
Überblick
The Panel also concluded that the following 7 ingredients are safe in cosmetics in the present practice of use and concentration described in this safety assessment, with the exception that the available data are insufficient to make a determination of safety for these ingredients in products that may be incidentally inhaled: Bentonite
Namen und Bezeichner
- Bevorzugter Name
- Bentonite
- IUPAC
- dialuminum;tetrakis(dioxosilane);tris(oxygen(2-));hydrate
- Englischer Name
- diosMectite
- Molmasse
- 0
Namen und Synonyme
Weitere Namen anzeigen
Datenbank-Bezeichner
- CAS
110070-78-5、1302-78-9、1318-93-0- PubChem CID
- 71586775
- ChEMBL
CHEMBL4298106- UNII
- A3N5ZCN45C、A585MN1H2L
- EC Number
- 215-108-5、215-288-5
Eigenschaften
Berechnete Struktureigenschaften
- Polarare Oberfläche (TPSA)
- 141 Ų
- H-Brücken-Donoren
- 1
- H-Brücken-Akzeptoren
- 12
- Frei drehbare Bindungen
- 0
- Schwere Atome
- 18
- Formalladung
- 0
- Komplexität
- 18,3
Experimentelle und physikochemische Eigenschaften
Chemical Classes
Mineral Dusts -> Other Mineral Dusts
Mineral Dusts -> Other Mineral Dusts
Cosmetics
Cosmetic ingredients (Bentonite) -> CIR (Cosmetic Ingredient Review)
Cosmetic ingredients (Montmorillonite) -> CIR (Cosmetic Ingredient Review)
Stabilizing; Bulking; Viscosity controlling; Absorbent; Cosmetic colorant; Emulsion stabilizing
Color/Form
A clay containing appreciable amounts of the clay mineral montmorillonite; light yellow or green, cream, pink, gray to black solid
The color in the massive condition varies from yellowish-white to almost black. The powder is cream colored to pale brown.
Light to cream-colored impalpable powder
The Clay Spur benonite usually ranges from 0.5 to 2 meters thick ... generally light yellowish green on the outcrop, becoming bluish green away from the outcrop.
For more Color/Form (Complete) data for BENTONITE (8 total), please visit the HSDB record page.
Powder
Solubility
Insoluble in water and common organic solvents
Solubility in water: none
Sicherheit und Regulatorisches
GHS-Klassifizierung
GHS Classification
This chemical does not meet GHS hazard criteria for 67.6% (2999 of 4439) of all reports.
Warning
H315 (31.8%): Causes skin irritation [Warning Skin corrosion/irritation]
P261, P264, P264+P265, P271, P280, P302+P352, P304+P340, P305+P351+P338, P319, P321, P332+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)
Aggregated GHS information provided per 4439 reports by companies from 18 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.
This chemical does not meet GHS hazard criteria for 96.1% (99 of 103) of all reports.
Gefahrenhinweise
Regulatory Information
Chemical: Bentonite
Chemical: Montmorillonite
Regulation (EC) No 1831/2003 (amended)
Bentonite is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Bentonite are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
Montmorillonite ((Al1.33-1.67Mg0.33-0.67)(Ca0-1Na0-1)0.33Si4(OH)2O10.xH2O) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Montmorillonite ((Al1.33-1.67Mg0.33-0.67)(Ca0-1Na0-1)0.33Si4(OH)2O10.xH2O) are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
Bentonite: Does not have an individual approval but may be used under an appropriate group standard
Other Safety Information
IMAP assessments - Montmorillonite: Human health tier I assessment
IMAP assessments - Bentonite: Human health tier I assessment
Fire Potential
Not combustible.
Not flammable or combustible.
Hazards Summary
A case of silicosis in a worker exposed to contaminated bentonite was reported in 1971, and other bentonite workers may be at risk for silicosis. No lung diseases caused by bentonite alone have been reported. [Rom, p. 527] The substance may have effects on the lungs, resulting in silicosis due to the presence of crystalline silica. [ICSC] See Montmorillonite.
Dust may cause respiratory tract irritation; [Merck Index] Dust may cause mechanical eye irritation and is irritating to the respiratory tract; [Acros Organics MSDS] See Bentonite.
FDA Requirements
Bentonite is an indirect food additive for use only as a component of adhesives.
Substance added directly to human food affirmed as generally recognized as safe (GRAS).
Bentonite used as a general purpose food additive in animal drugs, feeds, and related products is generally recognized as safe when used in accordance with good manufacturing or feeding practice.
Special Reports
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.[Elmore AR, Cosmetic Ingredient Review Expert Panel; Int J Toxicol 22 (Suppl 1): 37-102 (2003)]
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.[Elmore AR, Cosmetic Ingredient Review Expert Panel; Int J Toxicol 22 (Suppl 1): 37-102 (2003)]
FIFRA Requirements
Residues of bentonite are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Use: solid diluent, carrier.
Hazard Classes and Categories
Not Classified
Skin Irrit. 2 (31.8%)
Hazardous Reactivities and Incompatibilities
Bentonite particles are negatively charged and flocculation occurs when electrolytes or positively charged suspensions are added. Bentonite is thus said to be incompatible with strong electrolytes...
Incompatibilities: acids and acid salts decrease the water-absorbing power and thus cause a breakdown of the magma.
Strong oxidizing agents
Sicherheit und Schutzausrüstung
First Aid Measures
Fresh air, rest.
Rinse and then wash skin with water and soap.
Rinse with plenty of water (remove contact lenses if easily possible).
Fire Fighting Procedures
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
In case of fire in the surroundings; all extinguishing agents allowed.
Wear self contained breathing apparatus for fire fighting if necessary.
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Storage Conditions
Keep container tightly closed in a dry and well-ventilated place.
Bentonite should be stored in an airtight contaner in a cool, dry place.
Bentonite is hygroscopic, and sorption of atmospheric water should be avoided.
Keep container tightly closed in a dry and well-ventilated place.
Cleanup Methods
Sweep up and shovel. Keep in suitable, closed containers for disposal.
Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Sweep spilled substance into covered containers. If appropriate, moisten first to prevent dusting. Wash away remainder with plenty of water.
Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.
Disposal Methods
SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.
SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational harm/injury/toxicity or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal and plant life; and conformance with environmental and public health regulations.
Spillage Disposal
Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Sweep spilled substance into covered containers. If appropriate, moisten first to prevent dusting. Wash away remainder with plenty of water.
Preventive Measures
SRP: Local exhaust ventilation should be applied wherever there is an incidence of point source emissions or dispersion of regulated contaminants in the work area. Ventilation control of the contaminant as close to its point of generation is both the most economical and safest method to minimize personnel exposure to airborne contaminants. Ensure that the local ventilation moves the contaminant away from the worker.
Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed.
Toxikologische Informationen
Interactions
Numerous studies have established that aflatoxin is a potent developmental toxin in animals. Previous research has demonstrated that a phyllosilicate clay, hydrated sodium calcium aluminosilicate (HSCAS or Novasil), tightly binds and immobilizes aflatoxins in the gastrointestinal tract of animals and markedly reduces the bioavailability and toxicity of aflatoxin. Our objective in this study was to utilize the pregnant rat as an in vivo model to compare the potential of hydrated sodium calcium aluminosilicate and bentonite to prevent the developmental toxicity of aflatoxin. Aluminosilicates (HSCAS) and bentonite were added to the diet at a level of 0.5% (w/w) and fed to the pregnant rat throughout pregnancy (ie days 0-20). Test animals were fed an aflatoxin-contaminated diet (2.5 mg kg(-1) diet) with or without sorbents during gestation days 6-15. Evaluations of toxicity were performed on day 20. These included maternal (mortality, body weights, feed intake and litter weights), developmental (embryonic resorptions and fetal body weights) and biochemical (ALT, AST and AP) evaluations. Sorbents alone were not toxic and aflatoxin alone resulted in significant maternal and developmental toxicity. Animals treated with phyllosilicate (plus aflatoxin) were comparable to controls following evaluations for resorptions, live fetuses and fetal body weights, as well as biochemical parameters. While bentonite plus aflatoxin resulted in significant reduction in fetal body weight, none of the fetuses from hydrated sodium calcium aluminosilicate or bentonite plus aflatoxin-treated groups had any gross, internal soft tissue or major skeletal malformations.
Molasses, sodium bentonite (montmorillonite clay) and zeolite (crushed clinoptilolite rock) were examined as supplement ingredients to improve the safety margin of urea supplementation in a series of seven experiments. These experiments were designed to provide an understanding of the relationship between urea intake and the influence of the above ingredients on rumen pH and total ammonia concentrations. Rumen fistulated Merino ewes of 35-40 kg live weight were administered various amounts of urea with and without supplement mixes. Rumen parameters were measured at 0, 0.5, 1.0, 1.5, 2.5, 5.0 and 24 h after treatment administration. Acetic acid and sucrose were also tested together with molasses for comparative effects on rumen parameters. In the last experiment, blood pH and total plasma ammonia were also determined. Free ammonia values of rumen liquor were calculated for experiments 2 to 7. In four experiments, molasses at 50, 100 and/or 150 g mixed with urea significantly reduced the normal rapid rise in ruminal pH, total and free ammonia values compared with urea (10 g) only treatments. In two experiments, associated presence or absence of clinical toxicity at various quantities of urea (8 to 25 g) with and without active ingredients confirmed the positive effect of molasses in preventing toxicity at : 0.44 g urea/kg liveweight. The addition of molasses reduced the increase in ruminal pH by up to 0.5 pH units and absolute values were consistently below pH 7.0. Sucrose (100 g) and acetic acid (800 ml of 1 M) had the same and greater effect, respectively, compared with molasses (150 g) when added with urea (10 g) on ruminal pH and total and free ammonia changes over five hours post treatment. The partly hydrated urea/bentonite mix (approx 1:1 bentonite:water ratio) was associated with a delay in the increases in ruminal pH and free ammonia concentrations. Bentonite mixes, in either fully hydrated or fully dehydrated states, and zeolite mixes resulted in no significant effects. With reference to previous reports, the results support the positive role of a stable acid pH in the rumen for ensuring safe urea supplementation.
...Ingestion of large quantities of clay substances, such as bentonite, can result in gastrointestinal binding of essential electrolytes and possible obstruction. ...
/Investigators/ gave subplantar injections of 0.05 mL of a 5% solution of Bentonite to male Wistar rats. The rats either received both hind paw injections at an interval of 24 hr or their left paw was injected with Bentonite and their right paw injected with 0.05 mL of a 10% solution of Kaolin. The injection was of Kaolin. Subcutaneous Bentonite granulomas were produced on the left side, both dorsally and ventrally. Simultaneously Kaolin granulomas were produced on the right side analogous to the Bentonite injection. Sodium salicylate and prednisone suppressed the Bentonite edema during the first 24 hr. The presence of mononuclear cells was confirmed.
/Investigators/ administered a single dose of 40 mg of Bentonite suspended in 1 mL of physiological saline containing 40,000 IU of crystalline penicillin intratracheally to male CFY rats. The Bentonite's composition consisted of 73% Montmorillonite, 18% cristobalite, 3% quartz, 3% feldspar, and 3% other minerals. Particle sizes were <2 um. The control group received 1 mL of physiological saline containing 40,000 IU of crystalline penicillin. Animals were killed 12, 24, 48, or 72 hr or 90 days after exposure. Body and lung weight of the rats were measured. The right lung was fixed and sectioned for microscopic examination. The lipids and phospholipids were analyzed in the left lung. The body weights of the rats were moderately decreased and the lung weight increased 72 hr after Bentonite exposure. After 90 days, the lung weight was only slightly greater than that of the control animals. Upon microscopic examination at 12 hr, Bentonite exposure had resulted in a nonspecific inflammation of mostly neutrophils with perivascular edema, alveolitis, and incipient bronchopneumonia. A small number of macrophages and lymphocytes were detected. Dust particles were observed in the leukocytes and macrophages or extracellularly in the alveoli. After the 24th hr, bronchopneumonia was present after coalescence of the inflammatory foci; the pneumonia then became necrotizing and desquamative. Necrotic neutrophilic leukocytes and eosinophil leukocytes were observed. The reticular network collapsed between the 48th and 72nd hr. Exposure after 90 days included dust storage foci filled with large foamy cells with pale cytoplasm. Closely packed cells with dark cytoplasm and nuclei were located at the periphery. After 12 and 24 hr, the amount of lipids and phospholipids in the lungs was not altered. However, between 48 and 72 hr, the lipid and phospholipid content increase but distribution remained the same. After 90 days the value was the same as seen at 72 hr.
Poor aqueous solubility and the unpleasant taste of aripiprazole (APZ) have been recurring problems, owing to its low bioavailability and low patient tolerance, respectively. Herein, we prepared a nanohybrid system that was based on a bentonite clay material, montmorillonite (MMT), which could both mask the taste and enhance the solubility of APZ (i.e., APZ-MMT). To further improve the efficacy of this taste masking and drug solubility, APZ-MMT was also coated with a cationic polymer, polyvinylacetal diethylamino acetate (AEA). In vitro dissolution tests at neutral pH showed that the amount of drug that was released from the AEA-coated APZ-MMT was greatly suppressed (<1%) for the first 3 min, thus suggesting that AEA-coated APZ-MMT has strong potential for the taste masking of APZ. Notably, in simulated gastric juice at pH 1.2, the total percentage of APZ that was released within the first 2 hr increased up to 95% for AEA-coated APZ-MMT. Furthermore, this in vitro release profile was also similar to that of Abilify(c), a commercially available medication. In vivo experiments by using Sprague-Dawley rats were also performed to compare the pharmacokinetics of AEA-coated APZ-MMT and Abilify(c). AEA-coated APZ-MMT exhibited about 20% higher systemic exposure of APZ and its metabolite, dehydro-APZ, compared with Abilify(c). Therefore, a new MMT-based nanovehicle, which is coated with a cationic polymer, can act as a promising delivery system for both taste masking and for enhancing the bioavailability of APZ.
Toxicity Summary
The Panel also concluded that the following 7 ingredients are safe in cosmetics in the present practice of use and concentration described in this safety assessment, with the exception that the available data are insufficient to make a determination of safety for these ingredients in products that may be incidentally inhaled: Bentonite
Safe for use in cosmetics, with qualifications
The Panel also concluded that the following 7 ingredients are safe in cosmetics in the present practice of use and concentration described in this safety assessment, with the exception that the available data are insufficient to make a determination of safety for these ingredients in products that may be incidentally inhaled:Montmorillonite
Safe for use in cosmetics, with qualifications
IDENTIFICATION: Bentonite is a rock formed of highly colloidal and plastic clays composed mainly of montmorillonite and produced in situ devitrification of volcanic ash. It may contain feldspar, cristobalite and crystaline quartz. Major uses of bentonite include binding foundry sand in molds, absorbing grease, oil and animal wastes; palletizing taconite iron ore and improving the properties of drilling muds. It is used as an ingredient in ceramics, water proofing and sealing in civil engineering projects such as landfill sites and nuclear waste repositories, serving as a filter, stabilizer or extender in adhesives, paints, cosmetics and medicines. It is used as a bonding agent in animal feed, carrier for pesticides, clarifying wine and vegetable oil and purifying waste water. HUMAN EXPOSURE: In the view of widespread distribution of bentonite in nature and its use in various consumer products, general population exposure to low concentrations is ubiquitous. Occupational exposure to bentonite dust from mining, processing and user industries is a factor. ANIMAL STUDIES: Single intratracheal injection into rodents of bentonite and montmorillonite with low quartz content caused dose and particle side dependent effects, as well as transient local inflammation, which included edema and increased lung weight. Single intratracheal exposures of rats to bentonite caused storage foci in the lungs. After intratracheal exposure of rats to this material with high quartz content, fibrosis is noted. Mice maintained on diets containing bentonite displayed slightly reduced growth rates. Mice treated with higher doses showed minimal growth and fatty livers and fibrosis of the liver and benign hepatomas. Bentonite increased the susceptibility of mice to pulmonary infection. In vitro studies of the effects of bentonite on a variety of mammalian cell types indicated a high degree of cytotoxicity. Limited studies did not demonstrate developmental toxicity in rats after oral exposure to bentonite. No adequate studies are available on the carcinogenicity of bentonite.[
Ecotoxicity Excerpts
/AQUATIC SPECIES/ The present study was designed to investigate the effects of montmorillonite (MMT) on dietary Cd-induced oxidative damage in liver and kidney of carp (Carassius auratus). One hundred eighty carp were randomly divided into four groups and fed with a basal diet, a basal diet supplemented with 0.5% MMT, Cd-comtaminated basal diet (120 mg Cd/kg dry weight) and Cd-contaminated basal diet supplemented with 0.5% MMT, respectively. After 60 days, fish were sacrificed to measure malondialdehyde (MDA) content and antioxidative indices in liver and kidney. The results showed that the exposure of carp to dietary Cd caused decreases in glutathione peroxidase activity, catalase activity, superoxide dismutase activity, glutathione content and total antioxidant capacity level, while MMT supplemented in diet compensated Cd-induced decreases in above antioxidant indices to some extent in liver and kidney. As compared with the control group, increases in MDA content were observed in both measured tissues of carp exposed to dietary Cd, while MDA content decreased in carp exposed to Cd-contaminated basal diet supplemented with MMT in comparison with the Cd-contaminated group. It was suggested that MMT, when co-administered with Cd in diet, could alleviate dietary Cd-induced oxidative damage in liver and kidney of carp.
Signs and Symptoms
Cough.
Redness.
Redness. Pain.
Natural Pollution Sources
Clay of montmorillonite type, derived primarily from alteration of volcanic ash. Two distinct types of bentonite are (1) Wyoming and South Dakota deposits referred to as sodium montmorillonite having high gelling, swelling, and viscosity properties and (2) Mississippi bentonite referred to as calcium montmorillonite with little or no swelling capacity. /PRC: See CAS/RN 61029-13-8 & 1318-93-0/
Colloidal native hydrated aluminum silicate (clay) found in midwest of USA and in Canada. Consists principally of montmorillonite, Al2O3.4SiO2.H2O.
Wyoming; Mississippi; Texas; Canada; Italy; the former U.S.S.R.
The largest and highest quality sodium bentonite deposits in the world are located in South Dakota, Wyoming, and Montana ... The Clay Spur bentonite bed extends west from Belle Fourche, SD, and then north into Alberta, Canada.
For more Natural Pollution Sources (Complete) data for BENTONITE (8 total), please visit the HSDB record page.
Montmorillonite is ubiquitous in low concentrations worldwide in soil, sediment, and airborne dusts(1). The highest quality sodium bentonite deposits, which contain sodium montmorillonite, are located in South Dakota, Wyoming, and Montana. High quality calcium bentonite deposits, which contain calcium montmorillonite, are located in Texas and Mississippi, along with Arizona, Alabama, and Nevada(2).
Human Toxicity Excerpts
/HUMAN EXPOSURE STUDIES/ Effects of bentonite in workers in processing plant...very high incidence of bronchial asthma (25%) in workers examined, and attributed this to the irritant action of the bentonite dust on the bronchial epithelium.
/SIGNS AND SYMPTOMS/ /Investigators/ reported radiological evidence, not supported by autopsy, of significant damage to lungs following exposures to bentonite or montmorillonite dust of 10-42 years.
/CASE REPORTS/ Five workers exposed to bentonite or Fuller's earth for periods ranging from less than 15 years to more than 40 years developed dyspnea, in some cases accompanied by cough and sputum, and pneumoconiosis. The general characteristics of the pneumoconiosis of the above five workers, as revealed on autopsy, included emphysema, lesions, numerous firm black patches and nodules 1- 20 mm in diameter, dilated air sacs, adhesions, isolated cavities filled with "black sludge," and other evidence of physical deterioration. ...The accumulated dust amounted to 128 mg/g of dry lung (analyzed by transmission electron microscopy). There was very little or no fibrosis of the type associated with silicosis. Microscopic examination of lung tissue revealed that the nodules were aggregates of fine brown pigment lying free in tissue spaces or contained in macrophages held in a fine reticulum.
/CASE REPORTS/ /Investigators/ demonstrate that exposure to bentonite dust containing 5-11% silica can lead to silicosis. Exposure to this bentonite dust for 10 years with no other known exposure to silica dust led to advanced silicosis in three workers and to death, apparently from silicosis, in one of these three. All showed radiological evidence of silicosis, and the presence of silica in the lungs was confirmed by biopsy in one case.
For more Human Toxicity Excerpts (Complete) data for BENTONITE (14 total), please visit the HSDB record page.
/SIGNS AND SYMPTOMS/ /Investigators/ reported radiological evidence, not supported by autopsy, of significant damage to lungs following exposures to bentonite or montmorillonite dust of 10-42 years.
Artificial Pollution Sources
Bentonite's production and use in domestic products, cat litter, construction materials, ceramics, pharmaceuticals, beer and wine production and cosmetics(1) may result in its release to the environment through various waste streams(SRC). Its use in drilling muds, in agricultural practice as a carrier and an animal feed binder(1) will result in its direct release to the environment(SRC).
Montmorillonite's production and use in a wide variety of product types, including bath products, makeup and skin care products(1), lubricating greases; inks; paints; oil-based drilling fluids, adhesives; as granular in pet litter; to clarify wines, cider, beer; as floor absorbents; and in water clarification(2) may result in its release to the environment through various waste streams(SRC). Its use as carriers and diluents in pesticide preparations(2) will result in its direct release to the environment(SRC).
Non-Human Toxicity Excerpts
/LABORATORY ANIMALS: Acute Exposure/ Ten (5M:5F) albino rats, 200 - 254 g, each received a single oral dose of the test article at a concentration of 5 grams per kilogram bodyweight. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6, and 24 hours after treatment, and daily thereafter for a total of 14 days. Non-survivors and animals surviving the 14 day observation period were subjected to gross necropsy, with all findings noted. The test article was used as a 25 % gravimetric corn oil suspension. Dose Level:5 mg/kg Mortality: 0 % This test article is not toxic orally to rats under conditions of this test.
/LABORATORY ANIMALS: Acute Exposure/ Ten (5M:5F) albino rats, 210 - 298 g, were exposed to the test article at an atmospheric concentration of 200 milligrams per liter for 1 hour. Animals were observed for pharmacotoxic effects and mortality 1, 3, 6, and 24 hours after treatment, and daily thereafter for a total of 14 days. Non-survivors and animals sacrificed at the end of the 14 day observation period were subjected to gross necropsy, with all findings noted. The test article was used as received. Dose Level: 200 mg/L Mortality: 0 % The test article is not toxic to rats by inhalation under conditions of this test.
/LABORATORY ANIMALS: Acute Exposure/ Six (3M:3F) New Zealand white rabbits, 2.31- 3.19 kilograms, each received a single dermal application of the test article at a dose level of 2 grams per kilogram bodyweight. The skin of three (3J animals (2M:1F) was abraded; the remaining animals' skin remained intact. The test sites were occluded for 24 hours, at which time the occlusive wrap and any remaining test article were removed. Animals were observed for pharmacologic activity 1, 3, 6, and 24 hours after treatment, and daily thereafter for a total of 14 days. Non-survivors and animals surviving the 14 day observation period were subjected to gross necropsy, with all findings noted. The test article was moistened with saline. Dose Level: 2 g/kg. Mortality: 0 % This test article is not toxic dermally to rabbits under conditions of this test.
/LABORATORY ANIMALS: Acute Exposure/ Six (6) New Zealand white rabbits each received a single dermal application of 0.5 gram of the test article on two test sites, one abraded and one intact. The test sites were occluded for 24 hours, and were observed individually for erythema, edema, and other effects 24 and 72 hours after application. Mean scores from the 24 and 72 hour readings were averaged to determine the primary irritation index. The test article was moistened with water prior to use. Primary Irritation Index: 0.25. The test article is not a primary dermal irritant to rabbits under conditions of this test.
For more Non-Human Toxicity Excerpts (Complete) data for BENTONITE (20 total), please visit the HSDB record page.
/LABORATORY ANIMALS: Acute Exposure/ Single intratracheal injection into rodents of bentonite and montmorillonite with low content of quartz produced dose- and particle size-dependent cytotoxic effects, as well as transient local inflammation, the signs of which included edema and, consequently, increased lung weight.
Regulatorische Informationen
FDA Requirements
Bentonite is an indirect food additive for use only as a component of adhesives.
Substance added directly to human food affirmed as generally recognized as safe (GRAS).
Bentonite used as a general purpose food additive in animal drugs, feeds, and related products is generally recognized as safe when used in accordance with good manufacturing or feeding practice.
FIFRA Requirements
Residues of bentonite are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Use: solid diluent, carrier.
Chemie und Industrie
Pharmakologische Informationen
ATC Code
A - Alimentary tract and metabolism
QA - Alimentary tract and metabolism
Mechanism of Action
The mechanism by which bentonite increases susceptibility is unknown. /Investigators/ however, postulated that enzyme inhibition by bentonite may be a factor, based on their in vitro observation that a low concentration of bentonite can totally suppress the activity of human leukocyte elastase, an enzyme important in the destruction of microorganisms phagocytized by neutrophils.
Verwendung und Herstellung
Uses
CIR ingredient: Bentonite
CIR ingredient: Montmorillonite
Mined in Wyoming from rocks that contain at least 75% sodium montmorillonite or beidelite; Silica content ranges from <1% to 25%; Workers in milling plants are exposed to the highest concentrations of this dust. Used in foundry sand, drilling mud, and iron ore palletizing; [Rom, p. 526] Also used in cat litter, waterproofing materials, and animal feed; [HSDB]
Steel Producing [Category: Industry]
Permitted for use as an inert ingredient in non-food pesticide products; [EPA] Clay that is the main component of bentonite and Fuller's earth; Used in industrial chromatography, as an adsorbent, in the petroleum industry, and as a catalyst carrier; [Merck Index] A smectite phyllosilicate mineral with high cation exchange capacity and the ability to rapidly take up water; [INCHEM EHC]
Petroleum Production and Refining [Category: Industry]
Impurities
Cheto Arizona bentonite contains a small amount of kaolinite with quartz, micas, and feldspars as common non-clay impurities.
The principle constituent is Montmorillonite. However, other minerals such as illite, kaolinite, and nonargillaceous detrital minerals can be present. Most Bentonites appear relatively pure and other mineral contributions rarely exceed 10%. Cristobalite is often present. Montmorillonite compositions frequently vary either in its lattice structure or in the exchangeable ions present.
U.S. Exports
(1972) 4.73X10+11 GRAMS
(1975) 4.05X10+11 GRAMS
Domestic bentonite producers reported exports of 427,000 t. ... exports destined for Canadian and Mexican markets (approximately 250,000 t).
The major export markets /for swelling bentonite/ were in drilling mud, foundry sand, and iron ore pelletizing applications.
For more U.S. Exports (Complete) data for BENTONITE (6 total), please visit the HSDB record page.
U.S. Imports
(1972) 2.59X10+9 GRAMS
(1975) 2.14X10+9 GRAMS
Bentonite imports consisted mainly of untreated bentonite clay and chemically or artificially activated materials. ... untreated bentonite were 6,600 t ... chemically activated material were 18,900 t ...
U.S. Production
2023: 10,000,000 - <25,000,000 lb
2022: 390,500 lb
(1972) 2.51X10+12 GRAMS
(1975) 2.52X10+12 GRAMS
In thousand metric tons: (1995) 3,820; (1996) 3,740; (1997) 4,020; (1998) 3,820; (1999, est) 3,850
Production volume for non-confidential chemicals reported under the 2006 Inventory Update Rule. Chemical: Bentonite. Aggregated National Production Volume: 10 to < 50 million pounds.
Consumption Patterns
32% FOR IRON ORE PELLETIZING; 26% FOR DRILLING MUD; 25% FOR FOUNDRY SAND; 6% FOR MFR OF ANIMAL FEED; 4% FOR PURIFYING OILS; 1% FOR WATERPROOFING AND SEALING; 1% FOR PET LITTER ABSORBENT; AND 5% FOR MISCELLANEOUS USES (1975)
Domestic consumption decreased by approximately 2% in 1998. ... Domestic sales of bentonite for major markets were 869,000 ton for foundry sand bond, 773,000 ton for pet waste absorbent, 665,000 t for drilling mud, 529,000 ton for iron ore pelletizing, and 236,000 ton for sealant applications.
Total sales (domestic and exports) of swelling bentonite were approximately 725,000 t for drilling mud, 840,00 t for foundry sand bond, 588,000 t for pelletizing iron ore, 775,000 t for pet waste absorbent, and 143,000 t for waterproofing and sealing.
Reported domestic sales of bentonite were 1.02 million metric tons (Mt) for drilling mud (all swelling bentonite), 423,000 tons for foundry sand bond (more than 99% was swelling bentonite), 595,000 tons for pelletizing iron ore (all swelling bentonite), and 967,000 tons for pet waste absorbent (all swelling bentonite). Bentonite also was sold for civil engineering and sealing; fillers, extenders, and binders; waterproofing and sealing; and a variety of other applications. ... Domestic sales of bentonite increased for pet litter, drilling mud, pelletizing iron ore, waterproofing and sealing, and miscellaneous uses. Domestic sales of bentonite for drilling mud use increased by 74%, and export sales increased by 52%. Drilling activity increased domestically and overseas in 2010 compared with 2009. ...
For more Consumption Patterns (Complete) data for BENTONITE (6 total), please visit the HSDB record page.
Methods of Manufacturing
Bentonite beneficiation and processing involves relatively simple milling techniques that involve crushing or shredding, drying, and grinding and screening to suitable sizes.
Virtually all bentonite is strip-mined.
Formulations/Preparations
Hollander & McClanahan base is/ a hydrophilic base containing bentonite... /it contains/ petrolatum 32 g, bentonite 13 g, sodium lauryl sulfate 0.5 g, water 54 g, methylparaben 0.1 g /Bentonite USP/
Bentonite USP: magma USP (5%) /contains/ bentonite 5 g /&/ purified water, to make 100 mL. Ointment /contains/ bentonite 15 g, propylene glycol 15 mL, /&/ petrolatum, to make 100 g. /Bentonite USP/
Addition of a humectant (glycerin, sorbitol, etc) in amounts up to 10% will retard ... /drying/ action /of bentonite & water ointments/. /Bentonite USP/
Depending on sequence of mixing it is possible to prepare both oil/water and water/oil emulsions. When oil/water emulsion is desired, bentonite is first dispersed in water and allowed to hydrate so as to form a magma. The oil-phase phase is then added gradually with constant trituration. Because the aqueous phase is always in excess, the oil/water emulsion type is favored. To prepare water/oil emulsion, bentonite is first dispersed in oil; water is then added gradually.
For more Formulations/Preparations (Complete) data for BENTONITE (6 total), please visit the HSDB record page.
Household Products
Information on 10 consumer products that contain Montmorillonite in the following categories is provided:
Information on 153 consumer products that contain Bentonite in the following categories is provided:
Use Classification
EPA Safer Chemical Functional Use Classes -> Defoamers;Processing Aids and Additives
Safer Chemical Classes -> Green circle - The chemical has been verified to be of low concern
Food Additives -> ANTICAKING_AGENT -> JECFA Functional Classes
Cosmetics -> Stabilizing; Bulking; Viscosity controlling; Absorbent; Cosmetic colorant; Emulsion stabilizing
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