A formaldehyde releaser, formaldehyde donor or formaldehyde-releasing preservative is a chemical compound that slowly releases formaldehyde. Formaldehyde-releasers are added to prevent microbial growth and extend shelf life. [1] The intent of these compounds is that they release formaldehyde at levels that suppress microbial growth but sufficiently low to not threaten humans. The use of these chemicals in cosmetics has elicited controversy.
Many compounds have been formulated a formaldehyde-releasers. [2]
Some materials release formaldehyde unintentionally. These materials have also elicited considerable controversy, especially when these materials have household applications such as flooring. Examples:
They are found in fuels, cosmetics, toiletries, cleaning agents, adhesives, paints, lacquers, fertilizers, and metalworking fluids. [2] They are found in lysing agent for cells for in vitro diagnostic reagents. Photo-chemicals and press room chemicals also contain these releasers. [7]
Formaldehyde is dangerous to human health. [8] [9] In 2011, the US National Toxicology Program described formaldehyde as "known to be a human carcinogen". [10] [11] [12]
The danger of formaldehyde is a major reason for the development of formaldehyde releasers which release formaldehyde slowly at lower levels. [13]
Levels of 200–300 p.p.m. formaldehyde in cosmetic products can cause contact dermatitis in short-term use on normal skin. [13]
A patch test study found that DMDM hydantoin in cosmetic products could increase the risk of cosmetic dermatitis. [13]
Some people have a contact allergy to imidazolidinyl urea causing dermatitis. [14] Such people are often also allergic to diazolidinyl urea. In 2005–06, it was the 14th-most-prevalent allergen in patch tests (3.7%). [15]
Some consumer cosmetics contain quaternium-15 for its antimicrobial properties. [16] The American Cancer Society states that although quaternium-15 releases formaldehyde, a known carcinogen in laboratory test animals at relatively high doses, because the amount of formaldehyde released from these products is low, it is unclear that avoiding quaternium-15 in cosmetics provides any health benefits. [17] Even so, Johnson & Johnson announced plans to phase out its use of quaternium-15 in cosmetic products by 2015 in response to consumer pressure. [18]
Formaldehyde in the EU is restricted to a maximum allowed concentration in finished products no greater than 0.2%. [2] However, there are hidden sources of formaldehyde such as these formaldehyde releasers. As well, patch tests are prone to false positives at even low concentrations and not a reliable test. [2]
Sensitization to formaldehyde has been decreasing since 1980 due in part to the replacement of formaldehyde by these formaldehyde releasers. [2] As of 2009, frequency of sensitization to formaldehyde is stable at 2–3% in Europe. [2] It might be as high as 9% in the USA. [2] [13]
There are three groups of broad-spectrum preservatives with the most safety and efficacy. [19]
The FDA requires that cosmetics have an effective preservative, and microbial challenge testing is conducted. The EU's Cosmetic Directive 76/768/EEC requires the use of a preservative on an approved list. [19]
There are many ways to test and quantify formaldehyde. [13] However these methods are not suitable for the determination of free formaldehyde in cosmetics with formaldehyde releasers since these methods often accelerate release of formaldehyde. [20]
The physical method by 13C NMR spectroscopy does not affect the equilibrium between free and donor sources of formaldehyde and might be the best way to test for formaldehyde releasers. [13]
Sodium laureth sulfate (SLES), an accepted contraction of sodium lauryl ether sulfate (SLES), also called sodium alkylethersulfate, is an anionic detergent and surfactant found in many personal care products and for industrial uses. SLES is an inexpensive and very effective foaming agent. SLES, sodium lauryl sulfate (SLS), ammonium lauryl sulfate (ALS), and sodium pareth sulfate are surfactants that are used in many cosmetic products for their cleaning and emulsifying properties. It is derived from palm kernel oil or coconut oil. In herbicides, it is used as a surfactant to improve absorption of the herbicidal chemicals and reduces time the product takes to be rainfast, when enough of the herbicidal agent will be absorbed.
Formaldehyde ( fər-MAL-də-hide, alsofor-) (systematic name methanal) is a naturally occurring organic compound with the formula CH2O (H−CHO). The pure compound is a pungent-smelling colourless gas that polymerises spontaneously into paraformaldehyde (refer to section Forms below), hence it is stored as an aqueous solution (formalin), which is also used to store animal specimens. It is the simplest of the aldehydes (R−CHO). The common name of this substance comes from its similarity and relation to formic acid.
Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protect the body or skin. Cosmetics designed to enhance or alter one's appearance (makeup) can be used to conceal blemishes, enhance one's natural features, add color to a person's face, or change the appearance of the face entirely to resemble a different person, creature or object. Cosmetics can also be designed to add fragrance to the body.
Thiomersal (INN), or thimerosal, is an organomercury compound. It is a well-established antiseptic and antifungal agent.
Propylene glycol (IUPAC name: propane-1,2-diol) is a viscous, colorless liquid, which is nearly odorless but possesses a faintly sweet taste. Its chemical formula is CH3CH(OH)CH2OH. Containing two alcohol groups, it is classed as a diol. It is miscible with a broad range of solvents, including water, acetone, and chloroform. In general, glycols are non-irritating and have very low volatility.
Methylisothiazolinone, MIT, or MI, is the organic compound with the formula S(CH)2C(O)NCH3. It is a white solid. Isothiazolinones, a class of heterocycles, are used as biocides in numerous personal care products and other industrial applications. MIT and related compounds have attracted much attention for their allergenic properties, e.g. contact dermatitis.
Contact dermatitis is a type of acute or chronic inflammation of the skin caused by exposure to chemical or physical agents. Symptoms of contact dermatitis can include itchy or dry skin, a red rash, bumps, blisters, or swelling. These rashes are not contagious or life-threatening, but can be very uncomfortable.
Benzyl alcohol is an aromatic alcohol with the formula C6H5CH2OH. The benzyl group is often abbreviated "Bn" (not to be confused with "Bz" which is used for benzoyl), thus benzyl alcohol is denoted as BnOH. Benzyl alcohol is a colorless liquid with a mild pleasant aromatic odor. It is a useful solvent due to its polarity, low toxicity, and low vapor pressure. Benzyl alcohol has moderate solubility in water (4 g/100 mL) and is miscible in alcohols and diethyl ether. The anion produced by deprotonation of the alcohol group is known as benzylate or benzyloxide.
Quaternium-15 is a quaternary ammonium salt that has been used as a surfactant and preservative. It acts as an antimicrobial agent because it slowly releases formaldehyde, which is a preservative with biocidal properties.
Bronopol is an organic compound that is used as an antimicrobial. It is a white solid although commercial samples appear yellow.
A patch test is a diagnostic method used to determine which specific substances cause allergic inflammation of a patient's skin.
Allergic contact dermatitis (ACD) is a form of contact dermatitis that is the manifestation of an allergic response caused by contact with a substance; the other type being irritant contact dermatitis (ICD).
Green cleaning refers to using cleaning methods and products with environmentally friendly ingredients and procedures which are designed to preserve human health and environmental quality. Green cleaning techniques and products avoid the use of products which contain toxic chemicals, some of which emit volatile organic compounds causing respiratory, dermatological and other conditions. Green cleaning can also describe the way residential and industrial cleaning products are manufactured, packaged and distributed. If the manufacturing process is environmentally friendly and the products are biodegradable, then the term "green" or "eco-friendly" may apply.
Diazolidinyl urea is an antimicrobial preservative used in cosmetics. It is chemically related to imidazolidinyl urea which is used in the same way. Diazolidinyl urea acts as a formaldehyde releaser.
Isothiazolinone (sometimes isothiazolone) is an organic compound with the formula (CH)2SN(H)CO. A white solid, it is structurally related to isothiazole. Isothiazolone itself is of limited interest, but several of its derivatives are widely used preservatives and antimicrobials.
Imidazolidinyl urea is an antimicrobial preservative used in cosmetics. It is chemically related to diazolidinyl urea which is used in the same way. Imidazolidinyl urea acts as a formaldehyde releaser.
Amidoamines are a class of chemical compounds that are formed from fatty acids and amines. They are used as intermediates in the synthesis of surfactants, such as cocamidopropyl betaine (CAPB), some of which are used in personal care products including soaps, shampoos, and cosmetics. Amidoamines can also serve as curing agents for epoxy resins. They are also used as oil well drilling fluids and also as corrosion inhibitors.
DMDM hydantoin is an antimicrobial formaldehyde releaser preservative with the trade name Glydant. DMDM hydantoin is an organic compound belonging to a class of compounds known as hydantoins. It is used in the cosmetics industry and found in products like shampoos, hair conditioners, hair gels, and skin care products.
Iodopropynyl Butyl Carbamate (IPBC) is a water-soluble preservative used globally in the paints & coatings, wood preservatives, personal care, and cosmetics industries. IPBC is a member of the carbamate family of biocides. IPBC was invented in the 1970s and has a long history of effective use as an antifungal technology.
Methyldibromo glutaronitrile (MDBGN) is a widely used preservative.