Buy EK300 (Phenoxyethanol + Methyl,Butyl,Ethyl,Propyl & Isobutyl paraben) For Skin Care

EK300 (Phenoxyethanol + Methyl,Butyl,Ethyl,Propyl & Isobutyl paraben)

About EK300 (aka  Phenonip)  in DIY Skin Care

 

Safety and Efficacy of Parabens in Skin Care Products

 Parabens, the alkyl esters of p-hydroxybenzoic acids [PHBA], are a group of non persistent chemicals used individually or in mixtures to reach preferred antimicrobial and preservative effects. [1-2]

 Because of their substantial antimicrobial capacity, low toxicity, relatively non-irritating and non-sensitising properties, parabens have in various combinations been used as preservatives in cosmetics and toiletries for decades. Short chained parabens are more hydrophilic and the long chained are more lipophilic. When the chain length of the paraben increases, the resistance to hydrolysis and antimicrobial activity increase, but water solubility decreases. As a consequence, methylparaben and propylparaben which have shorter chains, are the ones most used in cosmetics. Methylparaben and propylparaben are however also preferred for use in foods [1].
 
Products found to contain parabens include hand soap, body lotion, shampoo, conditioner, face lotion, facial cleansers, foundation, lipstick, mascara, hair spray/mousse/gel, toothpaste and sunscreen. [3-5] One study identified parabens in 44% of cosmetics tested. [4] In personal care products tested in the US, concentrations of methylparaben up to 1.0% were found, with lipsticks containing the highest concentration ranging from 0.15% to 1.0%. The other parabens are used at concentrations lower than methylparaben in personal care products. [3]

The Safety of Parabens 

The estrogenic activity of parabens was first identified in 1998. and has since been validated in vitro and in vivo. [3,6-7] Parabens bind human estrogen receptors, although with affinities 10,000 to 1,000,000 times less than estradiol. [6,8] Butylparaben and propylparaben have higher estrogenic activity than methylparaben or ethylparaben, but butylparaben and propylparaben are detected at concentrations 10 to 1000 times less than methylparaben in humans. [9] The estrogenic effects in vivo have been demonstrated by uterotrophic [uterine growth] assays in mice and rats [1,10]. However, this effect did not prevent implantation of a fertilized egg, which is considered the most sensitive measure of estrogen toxicity. [10-11] It has been hypothesized that the estrogenic activity of parabens may promote breast cancer development. Dr Darbre reports finding parabens in samples of human breast tumour tissues but she also found quantities of parabens in “blank” samples that did not contain any tissue at all. [26-27] Thus, the significance of her results is not easy to ascertain. Extensive independent research has previously shown that any traces of parabens that might enter the skin are completely broken down by skin cells to harmless substances that cannot pose any risk of breast cancer. [26] The concentration of estradiol in normal human breast tissue is 55.3 pg/g, suggesting there is a safety margin of 10 to

1000 times for parabens to approximate normal estradiol activity. [3,9,12] The paraben breast cancer data shows no or low parabens in a subset of patients and there are no comparisons with normal controls. [12-13] According to a number of leading cancer research organisations, there is no plausible biological mechanism by which antiperspirants and deodorants could cause breast cancer. Dr Chris Flower of the CTPA said “Extensive research available to our members continues to indicate that there is no proven link between rising breast cancer rates and the use of antiperspirants or deodorants. Dr Darbre’s research is based on an extremely small sample of 20 breast tumour cases and does not include any reference samples from normal tissues.” [26] Hence, having not established a clear correlation, it is difficult to put forth a causal relationship between parabens and breast cancer development.
 
Another major area of study has been the effect of parabens on the male reproductive system, but findings are conflicting. [14] One in vitro study found that human sperm were not viable when exposed to parabens at concentrations of 1 mg/mL. [15] In vivo studies in mice did not replicate this result, with no spermatotoxic effects at paraben concentrations of 1%. [16] Conflicting results have also been reported in rats, with one study showing decreased sperm number and activity while another study found no adverse reproductive effects. [14,17] In humans, men with fertility problems including low sperm count and decreased motility were assayed for paraben exposure by measuring urine paraben levels. No correlation between sperm count or motility and parabens levels was found. [18]
 
Parabens, as is the case for many preservatives, can be allergenic in a small subset of the population. This sensitization commonly manifests as an eczematous rash. The rates of reported sensitization to parabens range from 0.5% to 3.5%. [19] These rates of sensitization are amongst the lowest of all preservatives. [19-20] In addition, there are reports of immediate immunoglobulin E mediated allergic reactions to parabens resulting in urticaria and, in one case, bronchospasm. [21-22] However, these immediate allergic reactions are extremely rare.

Regulatory Control of Parabens 

Government regulatory boards have examined parabens and most have agreed that current concentrations of parabens are safe for consumer use. The European Union [EU] has set up limits on paraben use that have also been reviewed by the European Scientific Committee on Consumer Products [SCCP]. In 2006, the SCCP concluded that parabens can be safely used in cosmetic products at concentrations of 0.4% for any individual paraben and 0.8% for total paraben concentrations. [3,23] These limits echo the legislative limits put in place by the EU. The Danish government went further in 2011. by banning the use of parabens in personal care products intended for children younger than 3 years of age. This decision is based on the possibility of high systemic absorption from an immature metabolism and skin barrier dysfunction. [24] In the United States, the Cosmetic Ingredient Review [CIR] assesses ingredients for safety and is reviewed by the US Food and Drug Administration [FDA]. The CIR

has recommended the same maximum paraben concentrations as suggested by the SCCP and as legislated by the EU. [3] However, it should be noted that the CIR recommendations are only guidelines and manufacturers are not required to follow them. Likewise in Canada, there are no laws regulating paraben concentrations, but Health Canada agrees with the FDA and the CIR in regards to the safety of parabens and the adoption of maximum concentration guidelines. [25] The French Commission on Cosmetology 2005 was of the opinion that more information is needed to confirm the safe use of parabens [especially for propyl- and butyl paraben] in cosmetic products. They concluded that there are no safety concerns at the currently allowed maximum levels for methyl- and ethylparabens. Additional studies concerning reprotoxic effects and pharmacokinetic fate are required in order to evaluate the risk of butyl- and propyl parabens. [26]

Parabens Preservative Efficacy 

Ideally a preservative should be effective against all types of organisms such as gram negative, gram positive, yeast and fungi. If there are gaps in its activity, then other preservatives will have to be added to ensure the formulation/product is adequately preserved. [26]
 
Parabens has been efficiently used for many decades. There are many studies that prove their efficacy. In 1935. Loos reported that Benzylparaben at 0,01% was effective in preventing the growth of the fungi Epidermophyton interdigitale and Microsporum audouni. [27] Lang and Rye in 1972. observed that the higher activity of the long chain esters over the shorter chain esters resulted from greater uptake of the former by bacterial cells. These authors suggested that because parabens are lipophilic, the action site was probably the cell membrane. [30] Bronswijk and Koekkoek in 1971. tested the activity of Methylparaben against Dermatophagoides pteronyssinus [house dust mite]. Growth of mites was suppressed by 1% Methylparaben, at 5% and 7% mite growth was completely inhibited. [31] According to Freese et al. [1973], parabens inhibit cellular oxidation by inhibiting compounds that donate electrons to the electron-transport mechanism of cell. In membrane vesicles of Bacilus subtilis, uptake of 1-serine, 1-leucine, and 1- malate was inhibited by Parabens. [32] In 1973. Allwood reported that nonionic surfactants at low concentrations may have a synergistic effect with parabens, whereas higher concentrations of the surfactant inhibit preservative activity. [33] Close and Neilson [1976] identified a Propylparaben resistant strain of Pseudomonas cepacia with esterases able to hydrolyze Propylparaben and use the metabolites as a carbon source. [34] According to Shiralkar et al. [1976], growth inhibition occurs only after a minimum concetration of paraben is reached, once this value is exceeded, inhibition is rapid. [35] O’Neill and Mead in 1982. studied the preservative capacity of parabens against Aspergillus niger, Enterobacter hafnia, Enterobacter cloacae, Escherichia coli, Penicillium species, Pseudomonas aerugionosa, P. cepacia, Pseudomonas putida, Serratia liquifaciens, S. marcescens and Serratia rubidaea. Methylparaben at 0.8% and mix of 0.4% Methylparaben and 0.4% Ethylparaben was effective, but Methylparaben at 0.4% was not effective, nor was a mix of 0,4% Methylparaben and 0.4% Propylparaben.  [36]  Nes  and  Eklund  in  1983.  reported  the  effect  of  Methyl-,  Propyl-  and

Butylparaben on DNA, RNA and protein synthesis in E.coli and B.subtilis. Inhibition of DNA synthesis was greatest with Butylparaben and least with Methylparaben. For all parabens, DNA synthesis inhibition increased as a function of paraben concentration. The same pattern was seen for RNA synthesis. Although protein synthesis was inhibited by parabens, the effect was much less in B.subtilis compared to E.coli. The authors speculated that DNA, RNA, and protein synthesis could be targets by parabens. [37]
 
Parabens are more effective against fungi than against bacteria. Their antibacterial activity is greatest against gram-positive organisms and poorest against Pseudomonas species. [38] Enhancement of antimicrobial coverage is achieved by combining parabens with other biocides such as formaldehyde releasers, isothiazolinones, or phenoxyethanol. [38-39] Cladosporium resinae, Pseudomonas aeruginosa, and Burkholderia cepacia have been reported to be resistant to parabens. [40-42]. Certain microorganisms, such as the gram-negative bacteria Enterobacter cloacae, Acinetobacter, Rhodopseudomona palustris, and Burkholderia cepacia, contain specific enzymes that degrade parabens [43-46]. A recent study showed a para-hydroxybenzoate hydroxylase gene [POBA/PRBA] in Enterobacter cloacae and Enterobacter gergoviae strains. This enzyme catabolizes para-hydroxybenzoic acid to the central intermediate protocatechuate, which is ultimately degraded to form tricarboxylic acid intermediates. [47] Blending of parabens also improves efficacy and this is one of the advantages of using various blends of parabens to improve efficacy. Some mixtures of parabens reduce efficacy while other mixtures show synergistic performance. This explains why there are so many blends of parabens on the market today. [26]
 

Quick guide to our preservatives:

• For facial washes, body washes, and shampoos: EK300
• For acidic creams/lotions (Vitamin C): EK300 or EPE9010
• For alkaline creams/lotions (SAP): EPE9010

CAS#: 122-99-6, 99-76-3, 120-47-8, 94-13-3, 94-26-8, 4247-02-3
INCI: EK300 - Phenoxyethanol (and) Methylparaben (and) Butylparaben (and) Ethylparaben (and) Propylparaben (and) Isobutylparaben
Data Sheet: Download here
Appearance: clear, colourless,nearly colourless liquid
Odour: characteristic
Flash point (DIN 51 758): > > 99 °C
Solubility:  Dissolve 1% EPE9010 (Ethylhexylglycerin + Phenoxyethanol) IN 6% Propanediol, add to final formulation and mix well.

pH stability:

• High (alkaline) pH values (> 8.0) should be avoided.
• Acidic pH values have no negative influence on the effectiveness.

Temperature stability: 

• Moderately stable to heat.
• Can be added to products at a temperature of no more than 70 °C.

Suggested percentage:

• 0.50%  to 0.1%
• Creams, lotions 0.50 - 0.1 %
• Shampoos, bath preparations 0.25-0.65 %

Usage:

• Use concentrations of 0.4-0.7%  are sufficient for emulsified systems of both the w/o and o/w types.
• Can only be dissolved in low concentrations when used in purely aqueous systems 
• In formulations with a low water content, heating to 60-70 °C may be sufficient for incorporation of a sufficient amounts into the aqueous phase.
• Can be dissolved in surfactants before the addition of water and other components.
• Cosmetic products of all kinds are adequately preserved with a use- concentration of 0.25-1.0 %. The higher concentrations are especially necessary for formulations that are difficult to preserve.
• Foam baths and shower preparations can normally be preserved with concentrations of 0.25-0.65 %.
• Products with a high protein content require rather higher use-concentrations.
• Products based on non-ionic surfactants require higher concentrations of in the range from 0.5-1.0 %.

Chemical compatibility:

• Fully effective both in anionic as well as cationic systems.
• High pH values (> pH 8.0) should be avoided
• Fully effective in acidic media.
• Proved to have good chemical compatibility with anionic surfactants such as sulphates, ether sulphates and sulphonates, as well as with non-ionogenic surfactants.
• Non-ionic surfactants and ether sulphates lead to losses of effectiveness.
• Exhibits no interactions with sulphite ions.

Storage: at room temperature.

[1] Soni MG, Burdock GA, Taylor SL, Greenberg NA. Safety assessment of propyl paraben: a review of the published literature. Food Chem Toxicol. 2001;39[6]:513-32
[2] Frederiksen H, Nielsen JKS, Mørck TA, Hansen PW, Jensen JF, Nielsen O, et al. Urinary excretion of phthalate metabolites, phenols and parabens in rural and urban Danish mother–child pairs. Int J Hyg Envir Heal. 2013;216[6]:772–83.
[3] Cosmetic Ingredient Review Expert Panel. Final amended report on the safety assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in cosmetic products. Int J Toxicol. 2008;27[Suppl 4]:1–82.
[4] Yazar K, Johnsson S, Lind ML, et al. Preservatives and fragrances in selected consumer- available cosmetics and detergents. Contact Dermatitis. 2011 May;64[5]:265–72.
[5] Witorsch RJ, Thomas JA. Personal care products and endocrine disruption: A critical review of the literature. Crit Rev Toxicol. 2010 Nov;40[Suppl 3]:1–30.
[6] Routledge EJ, Parker J, Odum J, et al. Some alkyl hydroxy benzoate preservatives [parabens] are estrogenic. Toxicol Appl Pharmacol. 1998 Nov;153[1]:12–9.
[7] Harvey PW, Darbre P. Endocrine disrupters and human health: could oestrogenic chemicals in body care cosmetics adversely affect breast cancer incidence in women? J Appl Toxicol. 2004 May;24[3]:167–76.
[8] Blair RM, Fang H, Branham WS, et al. The estrogen receptor relative binding affinities of 188 natural and xenochemicals: structural diversity of ligands. Toxicol Sci. 2000 Mar;54[1]:138–53.
[9] Golden R, Gandy J, Vollmer G. A review of the endocrine activity of parabens and implications for potential risks to human health. Crit Rev Toxicol. 2005 Jun;35[5]:435–58.
[10] Shaw J, deCatanzaro D. Estrogenicity of parabens revisited: impact of parabens on early pregnancy and an uterotrophic assay in mice. Reprod Toxicol. 2009 Jul;28[1]:26–31.
[11] Daston GP. Developmental toxicity evaluation of butylparaben in Sprague-Dawley rats. Birth Defects Res B Dev Reprod Toxicol. 2004 Aug;71[4]:296–302.
[12] Barr L, Metaxas G, Harbach CA, et al. Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum. J Appl Toxicol. 2012 Mar;32[3]:219–32.
[13] Darbre PD, Aljarrah A, Miller WR, et al. Concentrations of parabens in human breast tumours. J Appl Toxicol. 2004 Jan;24[1]:5–13
[14] Kang KS, Che JH, Ryu DY, et al. Decreased sperm number and motile activity on the F1 offspring maternally exposed to butyl p-hydroxybenzoic acid [butyl paraben]. J Vet Med Sci. 2002 Mar;64[3]:227–35.
[15] Song BL, Li HY, Peng DR. In vitro spermicidal activity of parabens against human spermatozoa. Contraception. 1989 Mar;39[3]:331–5.
[16] Oishi S. Effects of butyl paraben on the male reproductive system in mice. Arch Toxicol. 2002 Jul;76[7]:423–9.
[17] Oishi S. Lack of spermatotoxic effects of methyl and ethyl esters of p-hydroxybenzoic acid in rats. Food Chem Toxicol. 2004 Nov;42[11]:1845–9.
[18] Meeker JD, Yang T, Ye X, et al. Urinary concentrations of parabens and serum hormone levels, semen quality parameters, and sperm DNA damage. Environ Health Perspect. 2011 Feb;119[2]:252–7.
[19] Cashman AL, Warshaw EM. Parabens: a review of epidemiology, structure, allergenicity, and hormonal properties. Dermatitis. 2005 Jun;16[2]:57–66.
[20] Sasseville D. Hypersensitivity to preservatives. Dermatol Ther. 2004;17[3]: 251–63.
[21] Grzanka A, Misiolek H, Filipowska A, et al. Adverse effects of local anaesthetics - allergy, toxic reactions or hypersensitivity. Anestezjol Intens Ter. 2010 Oct;42[4]:175–8.
[22] Kajimoto Y, Rosenberg ME, Kytta J, et al. Anaphylactoid skin reactions after intravenous regional anaesthesia using 0.5% prilocaine with or without preservative--a double-blind study. Acta Anaesthesiol Scand. 1995 Aug;39[6]:782–4.
[23] U.S. Food and Drug Administration. Parabens. Available at: http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm128042.htm Updated: 12/15/2014
[24] Boberg J, Taxvig C, Christiansen S, et al. Possible endocrine disrupting effects of parabens and their metabolites. Reprod Toxicol. 2010 Sep;30[2]:301–12.
[25] Health Canada. Consumer product safety: Safety of cosmetic ingredients. Available at: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/labelling-etiquetage/ingredients-eng.php Updated: 2014-04-11
[26] Paraben Compendium  [2004]: Spotlight on Parabens, Retrieved from [ 17.05.2015] http://www.dweckdata.com/Research_files/Paraben_compendium.pdf
[27] Darbre PD [1998]. Environmental contaminants in milk: the problem of organochlorine xenobiotics. Biochem Soc Trans 26: 106-112.
[28] Agence française de securite sanitaire des produits de sante [AFSSAPS]. Working document for the working meeting on Parabens - 31 August 2005: Safety Evaluation of Parabens in Afssaps.
[29] Loos, H. O. 1935. Zur bekampfung der epidermophytie der fube und hande mit benzoesaureprapara-ben [translated from the original German]. Arch. Dermat. Syph.173:109-116
[30] Lang, M., and R. M. Rye. 1973. Correlation between the antibacterial activity of some p - hydroxybenzoate esters and their cellular uptake. Microbios 7:199-207
[31] Bronswijk, J. E. V., and H. H. Koekkoek. 1971. Nipagin [p-methyl hidroxybenzoate] as a pesticide against a house dust mite. Dermatophagoides pteronyssinus. J. Med. Entymol. 8:748
[32] Freese, E., C. W. Sheu, and E. Galliers. 1973. Function of lipophilic acids as antimicrobial food additives. Nature 241:321-325.
[33] Allwood, M. C. 1973. Inhibition of Staphylococcus aureus by combinations of nonionic surface-active agents and antibacterial substances. Microbios 7:209-214.
[34] Close, J. A., and P. A. Nellsen. 1976. Resistance of a strain of Pseudomonas cepacia to esters of p-hydroxybenzoic acid. Appl. Environ. Microbiol. 31:718-722
[35] Shiralkar, N. D., S. P. Manjrekar, and D. V. Rege. 1976. Some antimicrobial properties of p– hydroxybenzoates [parabens]. Indian Food Packer 30:22-27
[36] O’Neil, J. J., and C. A. Mead. 1982. The parabens: Bacterial adaptation and preservative capacity. J. Spc. Cosmet. Chem. 33:75-84
[37] Nes, I. F., and T. Eklund. 1983. The effect of parabens on DNA, RNA, and protein synthesis in Escherichia coli and Bacilus subtilis. J. Appl. Bacteriol. 54:237-242.
[38] Rietschel RL, Fowler JF Jr. Allergy to preservatives and vehicles in cosmetics and toiletries. In: Rietschel RL, Fowler JF Jr, editors Fisher's contact dermatitis 5th ed Williams & Wilkins, Philadelphia: Lippincott; 2001. p. 211-59.
[39] Elder RL. Final report on the safety assessment of methylparaben, ethylparaben, propylparaben and butylparaben. J Am Coll Toxicol 1984;3:147-209.
[40] Sokoloski WT, Chidester CG, Honeywell GE. The hydrolysis of methyl p-hydroxybenzoate by Cladosporium resinae. Dev Ind Microbiol 1962;3:179-87.
[41] Hugo WB, Foster JHS. Growth of Pseudomonas aeruginosa in solutions of esters of p- hydroxybenzoic acid. J Pharm Pharmacol 1964;16:209.
[42] Close JA, Neilsen PA. Resistance of a strain of Pseudomonas cepacia to esters of p- hydroxybenzoic acid. Appl Environ Microbiol 1976;31:718-22.
[43] Valkova N, Lepine F, Labrio L, et al. Purification and characterization of PrbA, a new esterase from Enterobacter cloacae hydrolyzing the esters of 4-hydroxybenzoic acid [parabens]. J Biol Chem 2003;278:12779-85.
[44] Kok RG, D'Argenio DA, Ornston LN. Mutation analysis of PobR and PcaU, closely related transcription activation in Acinetobacter. J Bacteriol 1998;180:5058-69.
[45] Hutchinson J, Runge W, Mulvey M, et al. Burkholderia cepacia infections associated with intrinsically contaminated ultrasound gel: the role of microbial degradation of parabens. Infect Control Hosp Epidemiol 2004;25:291-6.
[46] Valkova N, Lepine F, Valeanu L, et al. Hydrolysis of 4-hydroxybenzoic acid esters [parabens] and their aerobic transformation into phenol by the resistant Enterobacter cloacae strain EM. Appl Environ Microbiol 2001;67:2404-9.
[47] Valkova N, Lepine F, Bollet C, et al. PrbA, a gene coding for an esterase hydrolyzing parabens in Enterobacter cloacae and Enterobacter gergoviae strains. J Bacteriol 2002;184:5011-7.

Click here to download all available sample recipes in a RAR file

Download and unzip using WinZip or 7-Zip (Free)

Solubility:  Dissolve 1% EPE9010 (Ethylhexylglycerin + Phenoxyethanol) IN 6% Propanediol, add to final formulation and mix well.

pH stability:

• High (alkaline) pH values (> 8.0) should be avoided.
• Acidic pH values have no negative influence on the effectiveness.

Temperature stability: 

• Moderately stable to heat.
• Can be added to products at a temperature of no more than 70 °C.

Suggested percentage:

• 0.50%  to 0.1%
• Creams, lotions 0.50 - 0.1 %
• Shampoos, bath preparations 0.25-0.65 %

Usage:

• Use concentrations of 0.4-0.7%  are sufficient for emulsified systems of both the w/o and o/w types.
• Can only be dissolved in low concentrations when used in purely aqueous systems 
• In formulations with a low water content, heating to 60-70 °C may be sufficient for incorporation of a sufficient amounts into the aqueous phase.
• Can be dissolved in surfactants before the addition of water and other components.
• Cosmetic products of all kinds are adequately preserved with a use- concentration of 0.25-1.0 %. The higher concentrations are especially necessary for formulations that are difficult to preserve.
• Foam baths and shower preparations can normally be preserved with concentrations of 0.25-0.65 %.
• Products with a high protein content require rather higher use-concentrations.
• Products based on non-ionic surfactants require higher concentrations of in the range from 0.5-1.0 %.

Chemical compatibility:

• Fully effective both in anionic as well as cationic systems.
• High pH values (> pH 8.0) should be avoided
• Fully effective in acidic media.
• Proved to have good chemical compatibility with anionic surfactants such as sulphates, ether sulphates and sulphonates, as well as with non-ionogenic surfactants.
• Non-ionic surfactants and ether sulphates lead to losses of effectiveness.
• Exhibits no interactions with sulphite ions.

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