Biomaterial Database

Formaldehyde Release From Personal Care Products: Chromotropic Acid Method Analysis. 2019

Anne Nikle, and Marna Ericson, and Erin Warshaw

BACKGROUND Preservatives such as formaldehyde and formaldehyde releasers (F/FRs) are found in personal care products. Studies from Europe and Israel have indicated that products with undeclared F/FRs on product labels may have detectable levels of formaldehyde. OBJECTIVE The aim of the study was to determine the presence of formaldehyde in samples of US personal care products. METHODS Fifty-four baby and adult products were tested with the chromotropic acid method. A blinded investigator graded the color change as mild, moderate, or strong. RESULTS All 8 products declaring F/FRs resulted in a deep purple color change, indicating a strong reaction. Of the 46 products with undeclared F/FRs, 4 (8.6%) were found to release formaldehyde. All 4 resulted in a light purple color change, indicating a mild reaction. CONCLUSIONS Overall, 4 of 54 products (7.4%) had label information, which did not match chromotropic acid method testing results. Clinicians and formaldehyde-allergic individuals should be aware of the limitations of product ingredient labeling in managing allergic contact dermatitis to formaldehyde.

UI	MeSH Term	Description	Entries
D008709	Methenamine	An anti-infective agent most commonly used in the treatment of urinary tract infections. Its anti-infective action derives from the slow release of formaldehyde by hydrolysis at acidic pH. (From Martindale, The Extra Pharmacopoeia, 30th ed, p173)	Hexamethylenetetramine,Hexamine,Aminoform,Hexamine Silver,Methenamine Silver,Silver Methenamine,Urotropin,Methenamine, Silver,Silver, Hexamine,Silver, Methenamine
D009282	Naphthalenesulfonates	A class of organic compounds that contains a naphthalene moiety linked to a sulfonic acid salt or ester.
D011356	Product Labeling	Use of written, printed, or graphic materials upon or accompanying a product or its container or wrapper. It includes purpose, effect, description, directions, hazards, warnings, and other relevant information.	Labeling, Product,Package Inserts,Product Labelling,Insert, Package,Inserts, Package,Labelling, Product,Package Insert
D003358	Cosmetics	Substances intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product. (U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Office of Cosmetics Fact Sheet (web page) Feb 1995)	Personal Care Products,Care Product, Personal,Care Products, Personal,Personal Care Product,Product, Personal Care,Products, Personal Care
D005557	Formaldehyde	A highly reactive aldehyde gas formed by oxidation or incomplete combustion of hydrocarbons. In solution, it has a wide range of uses: in the manufacture of resins and textiles, as a disinfectant, and as a laboratory fixative or preservative. Formaldehyde solution (formalin) is considered a hazardous compound, and its vapor toxic. (From Reynolds, Martindale The Extra Pharmacopoeia, 30th ed, p717)	Formalin,Formol,Methanal,Oxomethane
D006795	Household Products	Substances or materials used in the course of HOUSEHOLD WORK or personal routine.	Household Supplies,Household Product,Product, Household,Products, Household,Supplies, Household
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006827	Hydantoins	Compounds based on imidazolidine dione. Some derivatives are ANTICONVULSANTS.	Hydantoin,Imidazolidine-2,4-Diones,Imidazolidine 2,4 Diones
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014508	Urea	A compound formed in the liver from ammonia produced by the deamination of amino acids. It is the principal end product of protein catabolism and constitutes about one half of the total urinary solids.	Basodexan,Carbamide,Carmol