Preservation of cosmetics and toiletries

Hill, G.B.

doi:10.1007/978-94-011-1354-0_13

Cited by 13 publications

(9 citation statements)

References 10 publications

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“…According to the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumer (SCCNFP), a scientific advisory body of the European Commission, Hexamidine has a molecular weight of 354.54 Da and is soluble in water and insoluble in organic solvents (SCCNFP 2002). The antimicrobial activity of Hexamidine is optimum at pH 5 to 9 and may be inactivated by chloride or sulfate ions and some proteins (Hill 1995).…”

Section: Physical and Chemical Propertiesmentioning

confidence: 99%

Final Report on the Safety Assessment of Hexamidine and Hexamidine Diisethionate1

2007

Int J Toxicol

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Hexamidine Diisethionate functions as a biocide in cosmetics at concentrations of 0.03% to 0.1% in 38 cosmetic products. Hexamidine functions as a biocide and preservative in cosmetics, but is not in current use in cosmetics, but it is used in over-the-counter (OTC) drug products. Hexamidine was poorly absorbed by human cadaver skin when in water-oil formulations or in a gel that simulated a cosmetic product formulation. Hexamidine Diisethionate was poorly absorbed by the skin of live rats and was not stored in any tissue type. Hexamidine Diisethionate given to rats intravenously was rapidly metabolized to Hexamidine. Excretion was primarily via the feces, with a small amount excreted in the urine. Acute oral LD(50) values of Hexamidine Diisethionate were 0.71 to 2.5 g/kg in mice and 0.75 g/kg in rats. Dermal exposure to 4 g/kg Hexamidine Diisethionate in rats or up to 9.4 ml/kg of a 0.1% Hexamidine Diisethionate solution under occlusion in rabbits produced no mortality or other signs of toxicity. The no-observed-effect level (NOEL) for oral subchronic toxicity of Hexamidine Diisethionate in rats was 50 mg/kg/day. No signs of toxicity were observed with 2% Hexamidine Diisethionate in subchronic studies using rabbits. Application of 0.1 ml of 0.11% Hexamidine Diisethionate in aqueous solution to the eyes of rabbits produced transient reactions; 0.05% produced no reactions. Slight erythema was observed with 0.10% Hexamidine Diisethionate applied to the abraded skin of 1/11 albino rabbits. A 40% solution of Hexamidine Diisethionate applied to 10% of the body surface of rats produced slight erythema, slight edema, and scabbing in some animals at varying times after treatment. Hexamidine Diisethionate was not a sensitizer in the guinea pig maximization test or in an intracutaneous guinea pig sensitization test. Hexamidine Diisethionate was not a photosensitizer in albino rabbits. Hexamidine Diisethionate was not mutagenic in a bacterial reverse mutagenicity assay or clastogenic in mammalian cells. Hexamidine Diisethionate at 0.10% did not provoke primary irritation, inflammation, or sensitization in a clinical test of 200 human subjects. One case report of photosensitivity to Hexamidine and one of contact sensitivity to Hexamidine were reported. There were nine case reports of contact sensitivity to Hexamidine Diisethionate. A European safety assessment recommended a limit of 0.1% Hexamidine Diisethionate in leave-on and rinse-off cosmetic products. In considering the available data, the Cosmetic Ingredient Review (CIR) Expert Panel acknowledged the lack of carcinogenicity and reproductive/developmental toxicity data. Because genotoxicity studies were negative, and there were no structural alerts, the Panel concluded that it was unlikely that these ingredients would be carcinogenic. Because the rate of absorption of Hexamidine and Hexamidine Diisethionate is slow, there is no tissue accumulation, and excretion is rapid and complete, and there was no toxicity in a subchronic study, the Panel concluded that dermal expos...

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Section: Physical and Chemical Propertiesmentioning

confidence: 99%

Final Report on the Safety Assessment of Hexamidine and Hexamidine Diisethionate1

2007

Int J Toxicol

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“…Many of these products are complex formulations in which preservative activity may be reduced or, possibly potentiated by the other ingredients. Such product ingredients include ethylenediamine tetra‐acetic acid (EDTA) [12], which enhances preservative activity, especially against Gram‐negative bacteria [13], and non‐ionic surfactants, which reduce activity of preservatives such as parabens and quaternary ammonium compounds (QACs) [14].…”

Section: Principles Of the Design Of A Challenge Testmentioning

confidence: 99%

“…Cosmetic preservatives include alcohols, QACs, benzoic, dehydroacetic and sorbic acids, parabens, triclosan, formaldehyde and chlorhexidine [12]. A knowledge of their antimicrobial, chemical and physical properties is essential for proper formulation of cosmetic products and also when undertaking PETs.…”

Section: Principles Of the Design Of A Challenge Testmentioning

confidence: 99%

Challenge testing: principles and practice

Russell

2003

Intern J of Cosmetic Sci

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It is difficult to predict accurately the ultimate effectiveness of a preservative in any but the simplest cosmetic or pharmaceutical formulation. It is thus necessary to obtain some assurance of its likely in-use performance in a formulated product. A challenge test is a procedure in which a product is challenged by exposure to specified types of bacteria and fungi to determine whether it is adequately preserved. Assessment of preservative efficacy is needed over the intended shelf-life of that product. Test organisms should be representative of those likely to occur as contaminants during use and should consist of Gram-positive and Gram-negative bacteria, mould and yeast. In-house factory isolates obtained as a result of contamination of earlier batches of a product may also be included. The organisms, as single or mixed inocula, are inoculated (usually as a single challenge, although some advocate multiple challenges) into samples of the product and aliquots removed at appropriate intervals for the determination of survivors. Interpretation of data is normally based on pharmacopoeial or other official protocols. Challenge testing should be undertaken at the beginning, during and at the end of the shelf-life of the product. An alternative, the D-value, approach is open to criticism and further studies are required that utilize rapid methods, e.g. impedance, for the detection of survivors before these can be considered to be a suitable replacement for the more traditional but very time-consuming, viable counting procedures.

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“…Isopropyl and n-propyl alcohols are more effective bactericides than ethanol (Anon., 1965;Kelsey & Maurer, 1972), but are not sporicidal. They are miscible with water in all proportions, but isopropanol has a less objectionable odour than n-propanol and is considered as a suitable alternative to ethanol in various cosmetic products, either as a solvent or as a preservative (Bandelin, 1977;Hill, 1995). Isopropanol has viricidal activity, but not towards 'hydrophilic' (non-lipid-enveloped) viruses (Rutala, 1990).…”

Section: Isopropyl Alcohol (Isopropanol)mentioning

confidence: 99%

“…Subsequent chapters will discuss the factors influencing their activity and their role as disinfectants and antiseptics and as preservatives in a wide range of products or materials (Akers, 1984;Fels et al, 1987;Eklund, 1989;Gould & Jones, 1989;Wilkins & Board, 1989;Russell & Gould, 1991a,b;Kabara & Eklund, 1991;Seiler & Russell, 1991). Lists of preservatives are provided by Denyer and Wallhäusser (1990) and by Hill (1995). Additional information is provided on their mechanism of action and on the ways in which microorganisms show resistance.…”

Section: Introductionmentioning

confidence: 99%

Types of Antimicrobial Agents

Moore¹,

Payne²

Russell, Hugo &Amp; Ayliffe's Principles and Practice of Disinfection, Preservation &Amp; Sterilization

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Introduction 2 Phenols 2.1 Sources of phenols -the coal-tar industry 2.2 Properties of phenolic fractions 2.3 Formulation of coal-tar disinfectants 2.4 The modern range of solubilized and emulsified phenolic disinfectants 2.4.1 Cresol and soap solution British Pharmacopoeia (BP) 1963 (Lysol) 2.4.2 Black fluids 2.4.3 White fluids 2.5 Non-coal-tar phenols 2.5.1 4-Tertiary octylphenol 2.5.2 2-Phenylphenol (2-phenylphenoxide) 2.5.3 4-Hexylresorcinol 2.6 Halo and nitrophenols 2.6.1 2,4,6-Trichlorophenol 2.6.2 Pentachlorophenol (2-phenylphenoxide) 2.6.3 4-Chloro-3-methylphenol (chlorocresol) 2.6.4 4-Chloro-3,5-dimethylphenol (chloroxylenol; para-chloro-metaxylenol; PCMX) 2.6.5 2,4-Dichloro-3,5-dimethylphenol (dichloroxylenol; dichloro-meta-xylenol; DCMX) 2.6.6 4-Chloro-3-methylphenol (para-chlorometa-cresol; PCMC) 2.6.7 Monochloro-2-phenylphenol 2.6.8 2-Benzyl-4-chlorophenol (chlorphen; ortho-benzyl-para-chlorophenol; OBPCP) 2.6.9 Mixed chlorinated xylenols 2.6.10 Other halophenols 2.6.11 Nitrophenols 2.6.12 Formulated disinfectants containing chlorophenols 2.6.13 Phenol 2.7 Pine disinfectants 2.8Theory of solubilized systems 2.9The bisphenols 2.9.1 Derivatives of dihydroxydiphenylmethane 2.9.2 Derivatives of hydroxydiphenylether 2.9.3 Derivatives of diphenylsulphide 3 Organic and inorganic acids: esters and salts 3.1

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Preservation of cosmetics and toiletries

Cited by 13 publications

References 10 publications

Final Report on the Safety Assessment of Hexamidine and Hexamidine Diisethionate1

Final Report on the Safety Assessment of Hexamidine and Hexamidine Diisethionate1

Challenge testing: principles and practice

Types of Antimicrobial Agents

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