Petrolatum

Summary

Petrolatum, commonly known as Vaseline, is a crucial lubricant used in various industries, including medicine, cosmetics, fine chemicals, and precision instruments. In China, it is categorized into ordinary vaseline, industrial vaseline, and medical vaseline. Ordinary vaseline is employed in ointment preparations and as a softener for dark rubber products.

Performance

White or yellow homogeneous paste, almost odorless and tasteless, a mixture of liquid and solid paraffin hydrocarbons. Relative density: 0.815~0.830, viscosity: 0.01 ~ 0.02 Pa?s (100℃), flash point > 190℃ (open type), drop point: about 37~54℃. It is easy to dissolve in ethyl ether, petroleum ether, fatty oil, benzene, carbon disulfide, chloroform and turpentine, difficult to dissolve in ethanol and almost insoluble in water. It is heated into a transparent liquid, which can be fluorescent in the dark after ultraviolet radiation.

Uses

Industrial vaseline protects metal products against rust, lubricates machinery under light loads, and serves as a treating compound for leather and rubber softener. Industrial vaseline finds applications as a rubber softener, anti-rust agent for metal devices, and raw material for rust-proof grease.

Distinguishing test

Solubility: It is insoluble in water, easily soluble in carbon dioxide, soluble in ether and hexane (OT-42).

Toxicity

Safe for food (FDA, §172.880，2000). ADI has not been stipulated (FAO/WHO, 2001).

Utilization limit

Baked food 0.15%; candy 0.2%; dehydrated fruits and vegetables 0.02%; solid protein 0.1%(FDA，§172.880，2000).

Chemical properties

A white, yellow or light amber semisolid fatty substance. Transparent when thin-layered, slightly fluorescent. Insoluble in water, almost insoluble in cold or hot ethanol and cold anhydrous ethanol. Soluble in ether, hexane and most volatile or non-volatile oil; easily soluble in benzene, carbon disulfide, chloroform and turpentine.

Chemical Properties

clear to white solid

Brand name

Moroline (Schering-Plough HealthCare).

Reactivity Profile

Petrolatum is unreactive in most circumstances.

Health Hazard

LIQUID: Irritating to eyes.

Fire Hazard

Combustible.

Flammability and Explosibility

Notclassified

Pharmaceutical Applications

Medical vaseline includes white and yellow varieties, primarily used in ointments, skin protection creams, cosmetics, antirust and lubricating materials for medical instruments, and precision instruments. Known for its chemical inertness, semisolid nature, lipophilic properties, and good adhesion, medical petrolatum is suitable for various cosmetic formulations. It is widely used as an ointment base, demonstrating compatibility with a broad range of drugs without altering their properties. Hydrophilic vaseline, created by adding alcohols after heating and stirring, is an ointment base with strong permeability, stability, and minimal irritation. In pharmaceutical formulations, petrolatum serves as an emollient-ointment base, and in the cosmetic industry, it is used in creams and transdermal formulations. Additionally, sterile gauze dressings containing petrolatum may be used for nonadherent wound dressings or as a packing material.

Safety Profile

When heated to decomposition it emits acrid smoke and irritating fumes

Safety

Petrolatum is mainly used in topical pharmaceutical formulations and is generally considered to be a nonirritant and nontoxic material. Animal studies, in mice, have shown petrolatum to be nontoxic and noncarcinogenic following administration of a single subcutaneous 100 mg dose. Similarly, no adverse effects were observed in a 2-year feeding study with rats fed a diet containing 5% of petrolatum blends. Although petrolatum is generally nonirritant in humans following topical application, rare instances of allergic hypersensitivity reactions have been reported,as have cases of acne, in susceptible individuals following repeated use on facial skin. However, given the widespread use of petrolatum in topical products, there are few reports of irritant reactions. The allergic components of petrolatum appear to be polycyclic aromatic hydrocarbons present as impurities. The quantities of these materials found in petrolatum vary depending upon the source and degree of refining. Hypersensitivity appears to occur less with white petrolatum and it is therefore the preferred material for use in cosmetics and pharmaceuticals. Petrolatum has also been tentatively implicated in the formation of spherulosis of the upper respiratory tract following use of a petrolatum-based ointment packing after surgery,and lipoid pneumonia following excessive use in the perinasal area.Other adverse reactions to petrolatum include granulomas (paraffinomas) following injection into soft tissue.Also, when taken orally, petrolatum acts as a mild laxative and may inhibit the absorption of lipids and lipid-soluble nutrients. Petrolatum is widely used in direct and indirect food applications. In the USA, the daily dietary exposure to petrolatum is estimated to be 0.404 mg/kg body-weight. For further information see Mineral Oil and Paraffin.

Incompatibilities

Petrolatum is an inert material with few incompatibilities.

Regulatory Status

GRAS listed. Accepted for use in certain food applications in many countries worldwide. Included in the FDA Inactive Ingredients Database (ophthalmic preparations; oral capsules and tablets; otic, topical, and transdermal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.