Safety Assessment of Polyaminopropyl Biguanide (Polyhexamethylene Biguanide Hydrochloride) as Used in Cosmetics

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Polyaminopropyl Biguanide (polyhexamethylene biguanide hydrochloride), which functions as a preservative in cosmetic products. The Panel reviewed relevant data relating to the safety of this ingredient and concluded that Polyaminopropyl Biguanide is safe in cosmetics in the present practices of use and concentration described in the safety assessment, when formulated to be nonirritating and nonsensitizing, which may be based on a quantitative risk assessment or other accepted methodologies. The Panel also concluded that the data are insufficient to determine the safety of Polyaminopropyl Biguanide in products that may be incidentally inhaled.

Polyhexamethylene biguanide hydrochloride (PHMB)-properties and application of an antiseptic agent. A narrative review

“…According to the European Commission Regulations, PHMB has been considered as a suspected carcinogen in rodents, 45 leading to a classification as a Carcinogen of category 2 (suspected of causing cancer) and 3 (limited evidence of carcinogenicity). 46,47…”

“…According to the European Commission Regulations, PHMB has been considered as a suspected carcinogen in rodents, 45 leading to a classification as a Carcinogen of category 2 (suspected of causing cancer) and 3 (limited evidence of carcinogenicity). 46,47 However, there is no evidence of mutagenic, genotoxic, and neurotoxic effects of PHMB in a review of US Environmental Protection Agency, 48 so the present classification raises questions as to possible mechanism for the rodent carcinogenesis of PHMB.…”

Poly(hexamethylene biguanide) hydrochloride (PHMB)-based materials: synthesis, modification, properties, determination, and application

“…66,71 In Australia, formulations containing 5% or less of PHMB can be used for therapeutic purposes. 69 However, previous data substantiated that PHMB exhibited cytotoxicity in a dose-dependent manner, which means that the use of PHMB is only safe within limits. 67 This provides a reference basis for the use PHMB within limits.…”

“…A myriad of studies have been carried out to investigate the toxicity and biosafety of PHMB in the past few decades. [66][67][68][69] Overall, PHMB is classified as noncarcinogenic, non-mutagenic, and non-toxic for reproduction. 25 This conclusion could be consolidated by a recent study by Chindera et al, who demonstrated that PHMB was unable to enter the nuclei of mammalian cells, while it could selectively destroy the bacterial chromosomes.…”

Polyhexamethylene biguanide and its antimicrobial role in wound healing: a narrative review

“…[17][18][19] It has been shown to have a limited effect on mammalian cells. 18 There is evidence that there is a wide safety margin when used in cosmetic 20 and clinical applications, 21 including wound care treatments. 22 It has low absorption via the epidermis and therefore a low probability of occurrence of allergic reactions.…”