Name: Ceresin
CAS No: Ceresin [8001-75-0]
Non Adopted
Cera mineralis alba; ceresine; ceresine wax; ceresin wax; cerin; cerosin; Cirashine CS; earth wax; GS-Ceresin; Koster Keunen Ceresine; mineral wax; purified ozokerite; Ross Ceresine Wax; white ceresin wax; white ozokerite wax
Ceresin [8001-75-0]
Ceresin is a mineral wax composed of a wide and complex range of long-chain, high-molecular-weight, saturated and unsaturated hydrocarbons, ranging from C20 to C32.
See Section 4
Ceresin is used as a stiffening agent in creams and ointments,(1,2) and as an emulsion stabilizer, opacifier, viscosity control agent, and thickener in pharmaceutical protective, topical, and vaginal creams.(3) It is also used in cosmetics and personal care products (see Section 18). Ceresin is often used as a substitute for ozokerite wax due to its similar properties, and also as a substitute for beeswax and paraffin wax. It acts as a rheological modifier at low concentrations (2–3%) and has the ability to create very small crystallites, which crosslink and establish a network structure that does not allow flow in practical conditions.(4) Ceresin produces stable mixtures with oils and prevents bleeding or sweating of oil, and it produces a lighter cream that is less greasy. Ceresin is also used for pharmaceutical coating applications of medicaments, for example, protective coatings,(5) enteric coatings,(6) and sustained-release coatings.(7) It has been used in the formulation of multivesicular emulsion topical delivery systems.(8)
Ceresin is a white-to-yellow waxy mixture of hydrocarbons obtained by purification of ozokerite. It occurs as odorless, tasteless, amorphous (noncrystalline) brittle, waxy cakes or pastilles.
See Section 18.
Density 0.91–0.92 g/cm3 Flash point 5204.48C(9) Iodine value 7–9(10) Melting point 61–788C Solubility Soluble in benzene, chloroform, naphtha, hot oils, petroleum ether, 30 parts absolute ethanol, turpentine, carbon disulfide, and most organic solvents. Insoluble in water. Viscosity (kinematic) 4.0 mm2 /s (4.0 cSt) at 1008C(11)
Ceresin should be stored in well-closed containers in a cool, dry, well-ventilated place, away from extreme heat and strong oxidizing agents.
Ceresin is incompatible with strong oxidizing agents. It is compatible with most animal, vegetable, and mineral waxes, as well as mineral oil and petrolatum.
Ceresin is prepared by extraction and purification of the native mineral fossil wax ozokerite, which is derived from coal and shale. Ozokerite is mined from deposits in various localities around the world. It is found as irregular mineral veins or as a black mass in clay strata. Mined ozokerite is heated to melt it, and any earth or rock is removed. If necessary, it is heated to 115–1208C to remove any moisture and then treated with sulfuric acid or fuming sulfuric acid. After neutralization, it is decolorized using activated charcoal or silica gel, and filtered. If decolorizing is not sufficient, it is repeatedly treated with sulfuric acid and subjected to adsorption filtration to produce more refined ceresin. Another method of producing ceresin involves dissolving ozokerite in ligroin, treating it with activated clay, and then removing the high-boiling-point fraction
Ceresin is nontoxic, nonhazardous, and safe for use in personal care and cosmetic ingredients in the present practices of concentration and use. The Cosmetic Ingredient Review Expert Panel has concluded that ceresin does not result in dermal sensitization. When formulations containing these ingredients were tested, they produced no skin irritation and the formulations were not phototoxic.(12) Ceresin may be slightly hazardous on ingestion and inhalation.(13) No definitive information is available on carcinogenicity, mutagenicity, target organs, or developmental toxicity. The FDA has established a cumulative estimated daily intake of ceresin of 0.00035 mg/kg body weight, and a cumulative dietary concentration in food of not more than 7 ppb.(14)
Observe normal precautions appropriate to the circumstances and quantity of the material handled. Ceresin should be handled in areas with adequate ventilation. Inhalation of vapors and contact with eyes, skin, and clothes should be avoided. Eye protection and gloves are recommended. Wash hands thoroughly after handling. Ceresin should be kept away from heat and sources of ignition as it may be combustible at high temperature.
Included in the FDA Inactive Ingredients Database (topical ointments; vaginal emulsions and creams). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines (topical creams) licensed in the UK. Accepted for use in cosmetics and personal care products marketed in Europe.
Wax, microcrystalline; wax, white; wax, yellow
A specification for ceresin is included in Japanese Pharmaceutical Excipients (JPE); see Table I.(15) Ceresin is used in many types of cosmetics and personal care products(16–18) including lipsticks,(19) lip salve, baby products, eye and facial makeup, as well as nail care, skin care, suntan, and sunscreen preparations,(20) deodorant sticks, fragrance, perfumes, pomades, and noncoloring hair preparations.(21) Ceresin is used in formulas that do not use animal products. It lessens the brittleness of cosmetic stick products, adding strength and stability, and it has been used in hair products as a waxy carrier.(22) Ceresin is used in dentistry as one of the primary components of dental wax compounds(23) along with beeswax and microcrystalline and paraffin wax, and it is used in dental impressions. It has also been used as a biodegradable wax in a sprayable, controlled-release insect control formulation.(24) The EINECS number for ceresin is 232-290-1. The PubChem Substance ID (SID) for ceresin is 204276