Ammonium Stearate
More safety information:
CIR Safety Review: The CIR Expert Panel reviewed acute oral studies indicating that the Stearate salts were practically nontoxic, and had a low potential for acute dermal toxicity. Skin irritation studies demonstrated that Stearates were only minimal to slight irritants at high concentrations. Pharmaceutical vehicles containing 5.5% Magnesium Stearate were neither teratogenic nor mutagenic.
Seven out of 20 human volunteers exhibited minimal to mild skin erythema when tested with an aqueous solution of 1.5% Ammonium Stearate. Similar results were obtained with Sodium Stearate at 0.5%. In a 21-day patch test with 10 subjects, an aqueous formulation containing 0.1-0.25% Sodium Stearate caused minimal skin irritation. No sensitization was reported in 100 subjects tested with the same formulation.
The CIR Expert Panel concluded that on the basis of the available information presented in the report that the Stearate salts were safe as cosmetic ingredients.
Link to FDA Code of Federal Regulations for the Stearate salts
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Lithium Stearate, Ammonium Stearate, Potassium Stearate and Sodium Stearate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. Aluminum, Calcium, Magnesium, and Zinc Stearates may be used as coloring agents in all cosmetics and personal care products (see Annex IV). If the stearic acid use to make these ingredients is derived from animal sources, it must comply with European Union animal by-products regulations.
Link to the EU Cosmetics Directive: http://ec.europa.eu/consumers/sectors/cosmetics/documents/di...
Seven out of 20 human volunteers exhibited minimal to mild skin erythema when tested with an aqueous solution of 1.5% Ammonium Stearate. Similar results were obtained with Sodium Stearate at 0.5%. In a 21-day patch test with 10 subjects, an aqueous formulation containing 0.1-0.25% Sodium Stearate caused minimal skin irritation. No sensitization was reported in 100 subjects tested with the same formulation.
The CIR Expert Panel concluded that on the basis of the available information presented in the report that the Stearate salts were safe as cosmetic ingredients.
Link to FDA Code of Federal Regulations for the Stearate salts
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Lithium Stearate, Ammonium Stearate, Potassium Stearate and Sodium Stearate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. Aluminum, Calcium, Magnesium, and Zinc Stearates may be used as coloring agents in all cosmetics and personal care products (see Annex IV). If the stearic acid use to make these ingredients is derived from animal sources, it must comply with European Union animal by-products regulations.
Link to the EU Cosmetics Directive: http://ec.europa.eu/consumers/sectors/cosmetics/documents/di...
More scientific information:
The commercial grade of stearic acid used to produce the Stearate salts contains fatty acids that range from 12 carbon atoms (C12, lauric) to C22 (behenic) and the major components are C18 (stearic) and C16 (palmitic) acids. In cosmetics and personal care products, the Stearate salts are used as emulsion stabilizers, viscosity increasing agents (nonaqueous), and opacifying agents. The water-insoluble metallic stearates are also water repellant and adhesive and have good “covering” properties.
