Zinc Stearate

Other Classes -> Stearates

Other Classes -> Stearates

Flammable agents - 2nd degree

Plastics -> PVC (soft); PVC (rigid); PET; PA

Plastics -> Other functions -> Lubricant

Cosmetic ingredients (Zinc Stearate) -> CIR (Cosmetic Ingredient Review)

Cosmetic colorant; Anticaking

Faint odor

Slight, characteristic odor

1.1 (NIOSH, 2024) - Denser than water; will sink

1.095 g/cu cm

1.1 g/cm³

1.10

1.095 @25 °C

1.10

White powder free from gritiness

Fine, soft, bulky powder

Insoluble (NIOSH, 2024)

Soluble in benzene; insoluble in water, alcohol and ether

Soluble in acids and common solvents when hot

Solubility in water: none

Insoluble

530 °F (NIOSH, 2024)

277 °C

530 °F Open Cup

277 °C o.c.

530 °F (open cup)

(oc) 530 °F

This chemical does not meet GHS hazard criteria for 61.3% (1292 of 2108) of all reports.

Warning

H335 (28.3%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposure; Respiratory tract irritation]

P261, P271, P273, P304+P340, P319, P391, P403+P233, P405, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 2108 reports by companies from 23 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

Not Classified

Chemical: Octadecanoic acid, zinc salt

Chemical: Octadecanoic acid, zinc salt, basic

Octadecanoic acid, zinc salt (2:1) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Octadecanoic acid, zinc salt (2:1) 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)

Status: Active Update: 11-01-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/5521

Zinc stearate: Does not have an individual approval but may be used under an appropriate group standard

The New Jersey Worker and Community Right to Know Act requires public and private employers to provide information about hazardous substances at their workplaces. (N.J.S.A. 34:5A-1 et. seq.)

IMAP assessments - Octadecanoic acid, zinc salt: Human health tier I assessment

Evaluation - Chemicals that are unlikely to require further regulation to manage risks to human health

A skin, eye, and respiratory tract irritant; [CAMEO] Acute stearate aspiration of large (but unknown) amounts (particularly zinc stearate) has been associated with pulmonary damage in infants. [ACGIH] See Zinc. See STEARATES.

This TLV Documentation applies only to stearic acid and magnesium, sodium, and zinc stearates. It excludes stearates of other metals. TLV Basis is lower respiratory tract irritation. No acute systemic effects of stearic acid have been reported after ingestion. . . . Sprague-Dawley rats fed stearic acid in their diet at 3000 ppm for 209 days showed 'severe pulmonary infection consisting of tracheobronchitis, lobular pneumonia, lipoid histiocytic response, and abscess formation.' [ACGIH] See Stearic acid.

The substances listed in paragraph (b) of this section may be safely used as antioxidants and/or stabilizers in polymers used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. Zinc stearate is included on this list.

Zinc stearate prepared from stearic acid free from chick edema factor used as a nutrient in food for human consumption is generally recognized as safe when used in accordance with good manufacturing practice.

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: zinc stearate is included in topical acne drug products.

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: zinc stearate is included in topical astringent drug products.

Zinc stearate prepared from stearic acid free from chick edema factor is generally recognized as safe when used as a nutrient and/or dietary supplement in accordance with good manufacturing or feeding practice.

European Chemicals Bureau; Risk Assessment Report on Zinc Distearate, CAS-No.: 557-05-1, 91051-01-3. EINECS-No.: 209-151-9, 293-049-4. Part I-Environment (May 2008) and PartII-Human Health (2004). Risk assessment reports provide scientific support to the development and implementation of EU polices related to health and consumer protection.[Available from, as of March 24, 2011: http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/zincdistearatereport074.pdf]

European Commission, ESIS; IUCLID Dataset, Zinc distearate (557-05-1) p.17 (2000 CD-ROM edition) contains information on use, toxicology, and environmental effects of this chemical as supplied to the European Union by industry.[Available from, as of February 7, 2011: http://esis.jrc.ec.europa.eu/]

Zinc and Health. Current Bibliographies in Medicine 98-3. Public Services Division/National Library of Medicine. 3619 citations January, 1990-June, 1998.[Available from, as of November 2, 1998: http://www.nlm.nih.gov/archive/20040831/pubs/cbm/zinc.html]

Residues of zinc stearate (conforming to CFR 182.5994 and 582.5994) 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 only. Use: flow control agent. Limit: none.

Residues of zinc stearate 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 animals. Use: water repellant, desiccant, and coating agent; stabilizer, component of plastic animal tags. Limit: none.

Permissible Exposure Limit: Table Z-1 8-Hr Time Weighted Avg: 15 mg/cu m. /Total dust/

Permissible Exposure Limit: Table Z-1 8-Hr Time Weighted Avg: 5 mg/cu m. /Respirable fraction/

Fresh air, rest. Refer for medical attention.

Rinse skin with plenty of water or shower.

First rinse with plenty of water for several minutes (remove contact lenses if easily possible), then refer for medical attention.

Rinse mouth. Give one or two glasses of water to drink.

Excerpt from NIOSH Pocket Guide for Zinc stearate:

(General first aid procedures)

Suitable extinguishing media. Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Special protective equipment for fire-fighters. Wear self contained breathing apparatus for fire fighting if necessary.

Water, foam, carbon dioxide, dry chemical.

Keep container tightly closed in a dry and well-ventilated place. Keep in a dry place.

Zinc stearate is stable and should be stored in a cool, dry place.

ACCIDENTAL RELEASE MEASURES. Personal precautions: Use personal protective equipment. Avoid dust formation. Avoid breathing dust. Ensure adequate ventilation. Environmental precautions: Do not let product enter drains. Methods and materials for containment and cleaning up: Pick up and arrange disposal without creating dust. Keep in suitable, closed containers for disposal.

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.

Observe all federal, state, and local environmental regulations. Contact a licensed professional waste disposal service to dispose of this material. Dispose contaminated packaging as unused product.

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. Carefully collect remainder. Then store and dispose of according to local regulations.

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.

Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.

Precautions for safe handling. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed. Normal measures for preventive fire protection.

If breathed in, move person into fresh air. If not breathing give artificial respiration Consult a physician. In case of skin contact, wash off with soap and plenty of water. Consult a physician. In case of eye contact, rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed, never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.

ACGIH Carcinogen - Not Classifiable.

ACGIH Carcinogen - Not Classifiable.

The substance can be absorbed into the body by inhalation of its aerosol.

inhalation, ingestion, skin and/or eye contact

Inhalation (L49) ; oral (L49) ; dermal (L49)

Safe in the present practices of use and concentration. Ingredient, concentration, and use information are available in documents discoverable at https://cir-reports.cir-safety.org

Anaemia results from the excessive absorption of zinc suppressing copper and iron absorption, most likely through competitive binding of intestinal mucosal cells. Unbalanced levels of copper and zinc binding to Cu,Zn-superoxide dismutase has been linked to amyotrophic lateral sclerosis (ALS). Stomach acid dissolves metallic zinc to give corrosive zinc chloride, which can cause damage to the stomach lining. Metal fume fever is thought to be an immune response to inhaled zinc. (L48, L49, A49)

/AQUATIC SPECIES/ The acute toxicity of zinc distearate to the waterflea Daphnia magna was determined according to OECD 202 in M7 medium at pH 6 and 8. Up to a loading rate of 100 mg zinc distearate/L the EC50 was not reached. The zinc concentration (detected using ICP-MS) at the beginning of the test was 1.2 mg Zn/L at pH 8 and 0.8 mg Zn/L at pH 6, at a loading rate of 100 mg zinc distearate/L. In the three available acute toxicity tests with fish, no effects were observed at nominal zinc distearate concentrations up to the water solubility limit or at nominal concentrations that were 3 to 4 orders of magnitude higher than the water solubility limit. From these data, although very limited, it is concluded that the ... acute toxicity of zinc distearate to Daphnia magna and fish is (far) above the water solubility limit of around 1 mg/L.

Cough.

irritation eyes, skin, upper respiratory system; cough

Ingestion of large doses of zinc causes stomach cramps, nausea, and vomiting. Acute inhalation of large amounts of zinc causes metal fume fever, which is characterized by chills, fever, headache, weakness, dryness of the nose and throat, chest pain, and coughing. Dermal contact with zinc results in skin irritation. (L49)

/HUMAN EXPOSURE STUDIES/ Two eyeshadow formulations, each containing 10% zinc stearate, were tested by means of the Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test. The former test resulted in "virtually 0 reactions in 202 subjects," whereas the latter one brought about "virtually 0 reactions in 99 subjects." One of the formulations was applied twice a day for 28 days to 52 female panelists. Each subject was then examined at baseline and one, two, three, and four weeks after application. No irritation or sensitization potential was exhibited by the panelists using this product under conditions of this test.

/CASE REPORTS/ A clinical study of 12 cases of aspiration of zinc-stearate dust in infants was reported. Three infants developed bronchopneumonia with symptoms of acute toxemia which lasted for 2 to 3 weeks. Rapid breathing, rapid pulse rate, and marked cyanosis were observed. Abdominal distension was marked in two cases. In eight cases, there was initial partial asphyxia followed by lung involvement. Necropsy of an 8 month old infant did not reveal significant gross morphology, but microscopically areas of interstitial round cell infiltration were observed. The bronchioles showed round and polymorphonuclear leukocytic infiltration of walls.

/CASE REPORTS/ ... Pneumoconiosis with probable heart failure /was observed/ in a rubber factory worker who had been occupationally exposed to zinc stearate dust for 29 years. Histological examination of lungs revealed bleeding, a significant increase in connective tissue, and chronic inflammation; likewise, numerous "granules and needles" in the fibrotic tissue that contained zinc were also observed.

/CASE REPORTS/ ... A case of pulmonary fibrosis in a chemical worker who had been occupationally exposed to zinc stearate dust for seven years /is described/. The amount of zinc retained in the lungs of the deceased worker (6.2 mg/100 g of dry lung tissue) was not significantly different than that retained in the lungs of persons who had not been occupationally exposed. It was the authors' opinion that zinc stearate was not the cause of lung fibrosis.

For more Human Toxicity Excerpts (Complete) data for ZINC STEARATE (8 total), please visit the HSDB record page.

No indication of carcinogenicity to humans (not listed by IARC).

No indication of carcinogenicity to humans (not listed by IARC).

/LABORATORY ANIMALS: Acute Exposure/ Zinc stearate was acutely irritating when injected into the lungs of rats and the peritoneum of guinea pigs. When 50 mg suspended in 1 mL of skim milk and saline was injected into the lungs of 50 rats, 20 died in less than 24 hours. Examination of the lungs revealed severe edema, congestion, and small hemorrhages. Animals that survived demonstrated no abnormality of the lungs after 14 or 259 days.

/LABORATORY ANIMALS: Acute Exposure/ When 100 mg zinc stearate suspended in 1 mL of tap water was injected into the lungs of six rats, all died as a result of acute edema of those organs. Guinea pigs injected intraperitoneally with either 50 mg (six guinea pigs) or 100 mg (six guinea pigs) zinc stearate suspended in 1 mL of tap water developed granulomata of the peritoneum. No permanent fibrosis resulted from the single injection of zinc stearate into the lungs of rats or into the peritoneum of guinea pigs.

/LABORATORY ANIMALS: Acute Exposure/ Sterile zinc-stearate was insufflated into dogs through a tube passed just beyond the vocal cords. The dogs suffered from loss of appetite and had fever with difficulty in breathing for a short period. Dogs were killed at different times after insufflation. Microscopically, congestion and increase of interstitial cells in the vicinity of bronchioles were observed. Other findings were pneumonitis, peribronchitis, and reduction in alveolar size. The authors conclude that dogs killed after talcum insufflation instead of zinc-stearate showed no gross pathology, and some, but less severe, microscopic changes similar to zinc-stearate treated animals.

/LABORATORY ANIMALS: Acute Exposure/ 500 mg zinc distearate (100%) was applied under occlusive conditions to the abraded and intact skin of 6 rabbits for 24 hours. The substance was not irritating.

For more Non-Human Toxicity Excerpts (Complete) data for ZINC STEARATE (9 total), please visit the HSDB record page.

The substances listed in paragraph (b) of this section may be safely used as antioxidants and/or stabilizers in polymers used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. Zinc stearate is included on this list.

Zinc stearate prepared from stearic acid free from chick edema factor used as a nutrient in food for human consumption is generally recognized as safe when used in accordance with good manufacturing practice.

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: zinc stearate is included in topical acne drug products.

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: zinc stearate is included in topical astringent drug products.

Zinc stearate prepared from stearic acid free from chick edema factor is generally recognized as safe when used as a nutrient and/or dietary supplement in accordance with good manufacturing or feeding practice.

Residues of zinc stearate (conforming to CFR 182.5994 and 582.5994) 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 only. Use: flow control agent. Limit: none.

Residues of zinc stearate 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 animals. Use: water repellant, desiccant, and coating agent; stabilizer, component of plastic animal tags. Limit: none.

(AZ) ARIZONA 5000 ug/L /Zinc/

(MN) MINNESOTA 2000 ug/L /Zinc/

EPA 5000 ug/L /Zinc/

EPA 2000 ug/L /Zinc, Lifetime health advisory/

For zinc, whole body: 162-500 days; [TDR, p. 1245]

In humans with no excessive intake of zinc, the body burden half-time of absorbed radio-labelled zinc has been observed to range from 162 to 500 days. After parenteral administration of 65Zn2+, half-times ranged from 100 to 500 days. /Zinc ions/

Zinc is mostly bound to organic ligands rather than free in solution as a cation. Zinc is found in diffusible and non-diffusible forms in the blood and about 66% of the diffusible form of zinc in the plasma is freely exchangeable and loosely bound to albumin. A small amount of the non-diffusible form of zinc is tightly bound to 2-macroglobulin in the plasma and is not freely exchangeable with other zinc ligands. Zinc is incorporated into and dissociated from alpha2-macroglobulin only in the liver. /Zinc ions/

Zinc can enter the body through the lungs, skin, and gastrointestinal tract. Intestinal absorption of zinc is controlled by zinc carrier protein CRIP. Zinc also binds to metallothioneins, which help prevent absorption of excess zinc. Zinc is widely distributed and found in all tissues and tissues fluids, concentrating in the liver, gastrointestinal tract, kidney, skin, lung, brain, heart, and pancreas. In the bloodstream zinc is found bound to carbonic anhydrase in erythrocytes, as well as bound to albumin, _2-macroglobulin, and amino acids in the the plasma. Albumin and amino acid bound zinc can diffuse across tissue membranes. Zinc is excreted in the urine and faeces. (L49)

In humans with no excessive intake of zinc, the body burden half-time of absorbed radio-labelled zinc has been observed to range from 162 to 500 days. After parenteral administration of 65Zn2+, half-times ranged from 100 to 500 days. /Zinc ions/

Within certain limits, mammals can maintain the total body zinc and the physiologically required levels of zinc in the various tissues constant, both at low and high dietary zinc intakes. The sites of regulation of zinc metabolism are: absorption of Zn2+ from the gastrointestinal tract, excretion of zinc in urine, exchange of zinc with erythrocytes, release of zinc from tissue, and secretion of zinc into the gastrointestinal tract. Regulation of gastrointestinal absorption and gastrointestinal secretion probably contributes the most to zinc homeostasis. /Zinc ions/

CIR ingredient: Zinc Stearate

Used to manufacture drugs, lacquers, and plastics; also used as a dietary supplement, waterproofing agent, heat and light stabilizer, and lubricant; [HSDB] Stearates are salts of octadecanoic acid. Zinc stearate is used in cosmetic powders for its adhesive properties. [ACGIH]

Used in cosmetics, pharmaceuticals, food additives, waterproofing agents, plastic stabilizers, emulsifiers, and rubber lubricants and dusting agents; Stearic acid occurs naturally in human and animal fats and oils and in some vegetable oils, including cocoa oil. Stearic acid can be prepared from animal fat (triglyceride) by treating with water at high temperature, leading to hydrolysis of triglycerides, or by hydrogenation of unsaturated vegetable oils such as cottonseed oil. [ACGIH]

In tablet manufacture; in cosmetic and pharmaceutical powders and ointments.

Zinc distearate is mainly used in the EU in the polymers industry as a stabilizer component (e.g. in PVC stabilisers), lubricant, mold release agent and dusting agent for rubber (55 %). Zinc distearate is further used in the paints, lacquers and varnishing industry as a sanding and flatting agent (18%), in the: building industry as a waterproofing agent in concrete (5%); in the paper; pulp; board and textile industry as a waterproofing agent (2%); in the cosmetics and pharmaceutical industry (1%); chemical industry (1%); metal industry (1%) and other applications.

Zinc stearate has been used in baby toiletries and bath powders as a dry lubricant to absorb moisture and prevent chafing.

2023: 25,000,000 - <40,000,000 lb

(1972) 8.8X10+9 GRAMS

(1975) 6.9X10+9 GRAMS

(1985) 27,925X10+3 lb

Octadecanoic acid, zinc salt is listed as a High Production Volume (HPV) chemical (65FR81686). Chemicals listed as HPV were produced in or imported into the U.S. in >1 million pounds in 1990 and/or 1994. The HPV list is based on the 1990 Inventory Update Rule. (IUR) (40 CFR part 710 subpart B; 51FR21438).

For more U.S. Production (Complete) data for ZINC STEARATE (6 total), please visit the HSDB record page.

Three methods are used to produce zinc distearate: 1) the double decomposition method, 2) the direct transformation process and 3) the fusion process. According to the industry only the first process generates waste water.

Action of sodium stearate on solution of zinc sulfate.

The insoluble metallic stearates are produced by reacting a selected grade of stearic acid with a caustic (usually sodium hydroxide) in an aqueous system. This produces a solution containing the soluble sodium salt of stearic acid. The insoluble metallic stearate precipitates out when a solution containing the desired metal is added to the sodium stearate solution. The insoluble stearate is then washed free of the water-soluble impurities, dried, milled, and packaged. /Insoluble metallic stearates/

An aqueous solution of zinc sulfate is added to sodium stearate solution to precipitate zinc stearate. The zinc stearate is then washed with water and dried. Zinc stearate may also be prepared from stearic acid and zinc chloride.

Zinc stearate USP; 60 g and 125 g shaker containers.

Grades: USP, technical, available from chick edema factor.

HyTech, HyDense, HyQual, RSN 131-HS, Wettable powder; DZS-36, SI-50, IPS, granular; XM powder; XM ultrafine dispersion SP grades; USP

Usually occurs as mixture of zinc salts of stearic and palmitic acids, and usually with some excess of zinc oxide. Contains 13.5-15% zinc oxide.

Plastics -> Other functions -> Lubricant

Plastics -> Polymer Type -> PVC (soft); PVC (rigid); PET; PA

Cosmetics -> Cosmetic colorant; Anticaking

Other (requires additional information)

Octadecanoic acid, zinc salt (2:1): ACTIVE

Polymer industry. Zinc distearate is typically added during the melt compounding process (all types of plastics and polymer masterbatches) or during the preparation of dry blends with polymer powders (e.g. PVC), pellets or beads (expandable polystyrene). Zinc distearate is added at low levels of smaller than 0.1 % of the final product in polystyrene, expandable polystyrene, some engineering plastics and some polyolefins (mould release / lubrication). Zinc distearate is used at higher concentrations (up to a few percent) as a component of (calcium/zinc) stabilisers in some PVC applications. All these processes are dry and are conducted in closed vessels or pipe work (industrial information).

Paints, lacquers and varnishes industry. Zinc distearate is used in furniture coatings as clear lacquers for industrial application on wood, seales and multicoatings, 2-pack polyurethane fillers, nitrocellulose fillers and lacquers and polyester primers. The content of zinc distearate in these products is 0.5-8 %. The split between solvent borne coatings and waterborne coatings is about 90:10.

Building industry. In the building or construction industry zinc distearate is used as a hydrophobic agent for the production of plaster. In this process zinc distearate is mixed together with cement, lime sand and other ingredients in powder form. The dry mortar will be mixed with water at the building site. In pre-mixtures the zinc distearate content is about 20%, the average dose of zinc distearate is about 0.3% (0.03% zinc metal).

Paper industry. Zinc stearate is used in the manufacture of thermal sensitive papers. These papers are used in fax machines, point of sale receipts and labels. The chemical mixture (incl. zinc stearate) acts as a slip agent preventing the paper from sticking to the print head of the imaging equipment. The mixture is purchased by the paper industry in powder form which are further mixed and ground to form an aqueous emulsion and blended with other chemicals to form a mix suitable for application to the paper.