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Phenoxyethanol-induced urticaria

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... Für die Epikutantestung wird seit über 20 Jahren eine Testkonzentration von 1% in Vaseline empfohlen, die häufig zu fraglichen und irritativen Reaktionen und wahrscheinlich auch zu vielen falsch-positiven Reaktionen führt (siehe Abschnitt "Sensibilisierungshäufigkeit") [27]. Es wurden auch Einzelfälle von Kontakturtikaria durch Phenoxyethanol beobachtet; der diesen Reaktionen zugrunde liegende Pathomechanismus ist nicht geklärt [3,4,18,20,22,24]. ...
... Seit 2001 wurden mehrfach Fälle von Kontakturtikaria durch die äußerliche Anwendung von Phenoxyethanol beobachtet. Der zugrundeliegende Pathomechanismus konnte bisher nicht geklärt werden; spezifisches Immunglobulin E gegen Phenoxyethanol wurde in keinem Fall nachgewiesen [3,4,18,20,22,24]. ...
... Several cases of contact dermatitis caused by 2-PE have been reported. [19][20][21] However, no specific IgE antibody was detected. 21 Although there is a report of anaphylaxis caused by 2-PE, the anaphylaxis was induced by a topical product. ...
... [19][20][21] However, no specific IgE antibody was detected. 21 Although there is a report of anaphylaxis caused by 2-PE, the anaphylaxis was induced by a topical product. 22 Use of 2-PE in vaccine products has gradually increased, replacing thimerosal. ...
Article
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Background: Influenza vaccines produced in embryonated eggs might pose a risk to patients with egg allergy. However, patients experiencing influenza vaccine-associated anaphylaxis (IVA) do not always have egg allergy. In the 2011-2012 season, an unusually high incidence of IVA was reported in Japan. Objective: We sought to identify the cause of the increase in anaphylactic events in 2011-2012 in Japan. Methods: We collected blood specimens from patients with IVA from all areas of Japan. We analyzed 19 patients with confirmed IVA and 25 age-matched control subjects, including 10 with egg allergy who had no adverse events after corresponding vaccination. ELISA was used to measure specific IgE levels to the trivalent vaccines of several manufacturers and hemagglutinin proteins derived from both egg and cell cultures. Antigen-induced basophil activation was evaluated by measuring CD203c expression by means of flow cytometry. Vaccine excipients were also examined for effects on CD203c expression. Results: None of the patients with IVA had severe egg allergy. Levels of specific IgE antibodies to influenza vaccine antigens, whole-vaccine products from different manufacturers, and hemagglutinin proteins (A H1, H3, and B) derived from both egg and cell cultures were significantly increased in patients with IVA compared with those in control subjects. Influenza vaccine-induced CD203c expression in basophils was also highly enhanced in patients with IVA but not in control subjects. Because IVA was most frequent in patients who received 2-phenoxyethanol (2-PE)-containing vaccine, the effect of this preservative on basophil activation was examined, and the activation was slightly enhanced by 2-PE but not thimerosal. Conclusions: The 2011-2012 IVA spike in Japan was caused by specific IgE antibodies to influenza vaccine components. Excipients could not be implicated, except for a modest effect of 2-PE.
... 34 The SCCS and the ANSM reported a small number of cases (n = 8) of skin allergy attributed to phenoxyethanol after topical contact with cosmetic products, medicines and metal-working fluids. [35][36][37][38][39][40][41][42] Amongst these, three cases had contact urticaria and the remaining cases had contact dermatitis. 35,36,39 In all three cases of contact urticaria, the manifestations appeared minutes after application of the cosmetic products and no respiratory symptoms were reported. ...
... [35][36][37][38][39][40][41][42] Amongst these, three cases had contact urticaria and the remaining cases had contact dermatitis. 35,36,39 In all three cases of contact urticaria, the manifestations appeared minutes after application of the cosmetic products and no respiratory symptoms were reported. A serum sample from one of the patients was tested for immunoglobulin E (IgE) antibodies against phenoxyethanol, and the presence of specific IgE could not be confirmed. ...
Article
Phenoxyethanol, or 2‐phenoxyethanol, has a large spectrum of antimicrobial activity and has been widely used as a preservative in cosmetic products for decades. It is effective against various Gram‐negative and Gram‐positive bacteria, as well as against yeasts, and has only a weak inhibitory effect on resident skin flora. According to the European Scientific Committee on Consumer Safety, phenoxyethanol is safe for all consumers – including children of all ages – when used as a preservative in cosmetic products at a maximum concentration of 1%. Adverse systemic effects have been observed in toxicological studies on animals but only when the levels of exposure were many magnitudes higher (around 200‐fold higher) than those to which consumers are exposed when using phenoxyethanol‐containing cosmetic products. Despite its widespread use in cosmetic products, phenoxyethanol is a rare sensitizer. It can be considered as one of the most well‐tolerated preservatives used in cosmetic products.
... These include allergic reactions, e.g. contact urticaria, [3][4][5] and transient erythema on the skin. 6 Commonly available pharmaceutical Octenisept, which is a mixture of 0.1% octenidine and 2% phenoxyethanol, was the cause of extensive peritonitis resulting from the rinsing with this antiseptic solution. ...
... Results of the PE determination in control, in pharmaceuticals and cosmetics by DPV compared with a reference HPLC method.Based on the Summary of Product Characteristics. 2 x = x av ± t 0.95 S av for n = 5 and t 0.95 = 2.776 (tabulated), S av -denote standard deviation of mean.3 Recovery, R = (x av /concentration involved) × 100%.4 Relative standard deviation.5 ...
Article
Full-text available
The first voltammetric method of identification and determination of phenoxyethanol (PE) in pharmaceutical and cosmetic preparations has been successfully developed. The measurements were carried out using differential pulse voltammetry (DPV) on a platinum microelectrode in glacial acetic acid containing acetonitrile (20%, v/v) and 0.1 mol L−1 sodium perchlorate as supporting electrolyte. A linear voltammetric response for PE was obtained in wide concentration range from 5.4 × 10−6 to 1.5 × 10−3 mol L−1, with low detection limit of 3.6 × 10−7 mol L−1. The repeatability and reproducibility of the peak current for phenoxyethanol concentration of 3.6 × 10−5 mol L−1 expressed as % RSD (n = 10) were very good and do not exceeded 0.5% and 0.8%, respectively. The obtained results indicate that the developed method allows sensitive, accurate and precise determination of PE in pharmaceuticals and cosmetics without the need for its separation from the matrices. The proposed method is simple and fast so it can serve as an analytical alternative for chromatographic techniques.
... An allergic reaction of the skin in the form of contact urticaria and contact dermatitis was associated with phenoxyethanol after topical application of medicines, cosmetic products, and metal-working fluids [29][30][31][32][33][34][35][36]. Application of ultrasound gel that contained phenoxyethanol was also found to be associated with Contact dermatitis and contact urticaria [37][38][39]. ...
Article
Full-text available
Phenoxyethanol is used at concentrations below 1% as a preservative in cosmetic products and fixative in perfumes. Some people have reported adverse responses to phenoxyethanol on their skin. Some suggest that the test subjects' negative reactions are the result of allergies. Nevertheless, there are claims that it's simply a skin irritant that has varying degrees of effect on various people. In 2012, the ANSM (French National Agency of Medicine and Health Products Safety) advised against using Phenoxyethanol in cosmetics for babies' bottoms. On a European level, this advice had not been confirmed. The purpose of this article is to discuss the potential negative effects of phenoxyethanol on newborns and infants.
... Phenoxy ethanol is a synergist for butylene glycol, due to its efficacy against Gram positive and Gram negative bacteria, as well as yeasts. Additionally, it shows a very low risk of causing contact dermatitisa prominent side effect of many preservatives (Bohn and Bircher, 2001;Lovell et al., 1984). ...
Article
Due to their role in immune responses, the skin dendritic cells (i.e. epidermal Langerhans cells and dermal dendritic cells) have become of great interest to researchers in the past decades. A dermal administration of allergens could target these professional antigen-presenting cells directly and build up immunotolerance. Additionally, many of the adverse side effects, which are seen in the current state of the art specific immunotherapy routes, could be avoided. Therefore, in this study a penetration enhancing microemulsion was developed and its physicochemical properties were determined under several storage conditions. The influence of different preservatives on the microemulsion stability was observed. We examined epidermal penetration of Alexa Fluor-647 labelled bee-venom phospholipase A2 (Api m 1) using the Franz diffusion cell set up and confocal laser-scanning microscopy. First results of an in-vivo Api m 1-allergic mouse model indicated the protective efficacy of dermal AIT with our newly developed microemulsion. Summarily, the developed microemulsion is a suitable, stable drug delivery system for the topical administration of proteogenic allergens into the epidermis and is able to reach dendritic cells in the skin.
... Systemic reactions have only been rarely reported. ere are few reports on contact urticaria with or without anaphylaxis due to phenoxyethanol [3][4][5][6][7]. In these cases, phenoxyethanol was an ingredient of cosmetics, such as moisturisers, body lotions, or a ershaves. ...
... Lujan et al. (81) reported one case of CU in a male patient, resulting from the use of an aftershave product containing phenoxyethanol. Three other cases of contact urticaria caused by cosmetics have been reported (78)(79)(80), but the presence of immunological IgE-mediated reactions could not be confirmed, as specific antibodies could not be identified (79). ...
Article
Immediate skin reactions are common in dermatological practice, but may often be overlooked. The main objective of this article is to provide an update of the literature concerning immediate-type reactions or contact urticaria/contact urticaria syndrome caused by cosmetic ingredients in terms of immediate clinical symptoms, positive reactions following open, scratch but, most often, prick testing, and sometimes the detection of specific IgE antibodies. To this end, a selective search in different medical literature databases was performed. This resulted in a list of cosmetic ingredients causing immediate reactions, including hair dyes and bleaches, preservatives, fragrance and aroma chemicals, sunscreens, hair glues, plant-derived and animal-derived components, permanent makeup and tattoos, glycolic acid peel, lip plumper, and alcohols. Many of the reported cases, however, lack appropriate controls and detailed investigation. In conclusion, contact urticaria may occur with or without systemic symptoms, which are sometimes life-threatening.
... parabenami. Znane s¹ przypadki pokrzywki kontaktowej wystêpuj¹cej po u¿yciu kosmetyku zawieraj¹cego 2-fenoksyetanol [18]. Alergia na metylodibromoglutaronitryl w populacji europejskiej wzros³a z 0,7% w 1991 r. do 3,5% w 2000 r. [19]. ...
... 2 There is a case report of phenoxyethanol-induced contact urticaria and an associated anaphylactic reaction. 3,4 We report a case of a child who developed urticarial rash caused by a phenoxyethanol-incorporated lip balm applied to facemask to facilitate inhalational anesthetic induction. ...
Article
Full-text available
Flavoring a facemask with a lip balm for inhalational induction in children is a common practice. However, most anesthesia providers are unaware of potential complications and the management of allergic reactions caused by lip balm. We describe the occurrence of allergic reaction to lip balm-flavored facemask in a child who underwent an inhalational anesthetic induction. The facial rash resolved completely without complications after administration of an antihistamine and steroid.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
... It is well understood that preservative concentrations are to be kept on lowest possible concentrations to minimize possible side effects while allowing antimicrobial efficacy [2,[21][22][23][24]. ...
Article
Antimicrobial testing is a time consuming and cost-intensive but essential method for evaluation of newly developed pharmaceutical formulations for topical use. In this study the correlation between free preservative concentration in emulsion gels measured by equilibrium dialysis and the successful preservative effectiveness testing for Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and Aspergillus brasiliensis (analyzed according to Ph. Eur. and USP) was investigated. The higher the lipophilicity of the oil phase and the lower the content of the aqueous phase with regard to dissolved ingredients the more preferably distributed is phenoxyethanol to the water phase and, consequently, the higher was the efficacy against the microbes. Increased emulsifier concentrations reduced the free amount of the preservative due to micellar interactions. Aspergillus brasiliensis was the most resistant and Staphylococcus aureus the most sensitive germ towards phenoxyethanol in o/w-emulsion gels.
... Inlinge (n = 13) vier Stunden nach Anwendung der Desinfektionslösung nachgewiesen (Bührer et al. 2002).Cheng et al. 2014;Chow et al. 2013;Goossens et al. 1998;Marks et al. 1998;Pratt et al. 2004;Schnuch et al. 19983) Die Positivity Ratio ist definiert als der Prozentsatz einfach positiver Reaktionen an der Gesamtheit der positiven Reaktionen (Geier et al. 2003). 2-Phenoxyethanol-haltiger Produkte wurde berichtet (Birnie und English 2006; Bohn undBircher 2001;Hernández et al. 2002;Lujan et al. 2009;Núñez Orjales et al. 2010). In diesen ist die zugrundeliegende Genese aber nicht geklärt und auch der Nachweis von spezifischem IgE gegen 2-Phenoxyethanol wurde bisher nicht beschrieben. ...
Chapter
The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re-evaluated 2-phenoxyethanol [122-99-6], considering all toxicity endpoints. Available publications and study reports are described in detail. In a 14-day inhalation study with rats, critical effects of 2-phenoxyethanol were hyperplasia, degeneration and metaplasia of the respiratory epithelium in the nasal cavity beginning at 246 mg/m3. The NOAEC was 48.2 mg/m3 (8.4 ml/m3). Since 2014, the Commission uses an empirical approach to set maximum concentrations at the workplace (MAK values) for substances with critical effects on the upper respiratory tract or the eyes. Based on this approach, a MAK value of 1 ml/m3 has been derived. The assignment to Peak Limitation Category I, because local effects are critical, and the excursion factor of 2 have been confirmed. No developmental toxicity was detected in rats (oral) or rabbits (dermal) up to doses of 1000 or 600 mg/kg body weight and day, resp. In an oral two-generation study in mice, the NOAEL for foetotoxicity was about 400 mg/kg body weight and day. The differences between the NOAEL for rats, mice and rabbits scaled to an inhalation concentration at the workplace and the MAK value are considered so large that damage to the embryo or foetus is unlikely when the MAK value is observed. Therefore, classification in Pregnancy Risk Group C is confirmed. 2-Phenoxyethanol is not regarded to be genotoxic or carcinogenic. Sensitization is not expected based on results of animal studies and experience in humans. Skin contact is not expected to contribute significantly to the systemic toxicity.
... In addition, dissemination indicating generalized exanthema on the trunk was observed in the test within 6 hours (Mock et al. 2002). There were reports of other individual cases of contact urticaria caused by the topical application of products containing 2-phenoxyethanol (Birnie and English 2006;Bohn and Bircher 2001;Hernández et al. 2002;Lujan et al. 2009;Núñez Orjales et al. 2010). However, these publications did not explain the genesis of these effects, and evidence of specific IgE to 2-phenoxyethanol has not been reported to date. ...
Chapter
The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated 2‐phenoxyethanol [122‐99‐6], considering all toxicity endpoints. Available publications and study reports are described in detail. In a 14‐day inhalation study with rats, critical effects of 2‐phenoxyethanol were hyperplasia, degeneration and metaplasia of the respiratory epithelium in the nasal cavity beginning at 246 mg/m3. The NOAEC was 48.2 mg/m3 (8.4 ml/m3). Since 2014, the Commission uses an empirical approach to set maximum concentrations at the workplace (MAK values) for substances with critical effects on the upper respiratory tract or the eyes. Based on this approach, a MAK value of 1 ml/m3 has been derived. The assignment to Peak Limitation Category I, because local effects are critical, and the excursion factor of 2 have been confirmed. No developmental toxicity was detected in rats (oral) or rabbits (dermal) up to doses of 1000 or 600 mg/kg body weight and day, resp. In an oral two‐generation study in mice, the NOAEL for foetotoxicity was about 400 mg/kg body weight and day. The differences between the NOAEL for rats, mice and rabbits scaled to an inhalation concentration at the workplace and the MAK value are considered so large that damage to the embryo or foetus is unlikely when the MAK value is observed. Therefore, classification in Pregnancy Risk Group C is confirmed. 2‐Phenoxyethanol is not regarded to be genotoxic or carcinogenic. Sensitization is not expected based on results of animal studies and experience in humans. Skin contact is not expected to contribute significantly to the systemic toxicity.
... It can be found in nail polish. Exposure to phenoxyethanol has been linked to reactions ranging from eczema28 to severe, life-threatening allergic reactions 29 . Phthalates can be found in nail polish and treatment. ...
Preprint
Full-text available
Toxic chemicals in nail products, especially in artificial nail products and colored nail polish can damage the nail and skin around the nail. Damaged nails are more prone to fungal infections than the intact nails. Fungal infections further damage the nail and skin around the nail. The more the nail is damaged, the more severe is the fungal infection. This is how the vicious circle of onychomycosis is closed. Before starting the treatment of onychomycosis, all cosmetic nail products must be removed, and must not be used during the treatment.
... However, phenoxetol being a high boiling liquid with a low vapor pressure, exposure to vapours to a concentration sufficient to cause such effects is unlikely at room temperature [40]. A case of an immediate hypersensitivity reaction has been reported by Bohn and Bircher in 2001 [41]. Limitations of the use of phenoxetol seem to be The results of this study are in agreement with those reported by Owen and Steedman in 1958 on zoological samples and by Steinmann et al in 1975 on veterinary and zoological samples [20,21]. ...
Article
The occurrence of pruritus immediately after application of an aftershave product is usually due to irritant contact dermatitis. We report a case of contact urticaria in a male patient, produced by an aftershave product containing phenoxyethanol.
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Cosmetics are substances or mixtures for an external contact with a human body: their skin, hair, lips, nails, external sex organs, teeth and mucous membranes of an oral cavity. The only or main aim of cosmetics is to keep the body clean, take care of it, protect, perfume as well as groom it. Since the products are supposed to be safe and well-tolerated, they tend to cause side effects, for instance irritation or allergy. This is mainly due to scented substances as well as preservatives which are included in cosmetics.
Article
Solaraze gel (Shire Deutschland GmbH & Co. KG, Cologne, Germany) containing 3% diclofenac has been licensed in 2001 as a topical treatment for actinic keratoses. It is commonly used in dermatological practice. Undesirable effects are believed to be rare but include pruritus, paresthesia and application-site reactions (dry skin, rash, erythema, contact dermatitis and vesicobullous eruptions). Recently, a few cases of contact dermatitis due to three different allergens including diclofenac have been reported (1,2).
Article
The care and moisturizing of cadavers for medical dissection courses, or for use with anatomical specimens, requires effective antimicrobial and fungicidal conservation chemicals. The chemical combinations used for this purpose mostly contain formaldehyde. Despite low concentrations and the implementation of adequate room ventilation, these chemicals can lead to health hazards. Phenoxyethanol (Ethylene glycol monophenyl ether) offers a potential way of minimizing the occupational hazards for students, teachers and personnel, without influencing the quality of the cadavers and anatomical specimens. From 1996 to 2003, approximately 3 000 people have participated in dissection courses where phenoxyethanol has been used for disinfection and moisturizing, and there has been no evidence, neither objective nor subjective, of any pathological symptomatology.
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Methyldibromoglutaronitrile/phenoxyethanol (Euxyl K 400) is a preservative found in both personal care products and industrial sources. Although Euxyl K 400 initially appeared to have low sensitizing potential, increased prevalence of contact allergy to Euxyl K 400 led to regulatory intervention. This review summarizes the history, epidemiology, and management of contact allergy to Euxyl K 400. Issues related to patch-test preparations are also discussed. © 2011 American Contact Dermatitis Society. All Rights Reserved.
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A toxicologic and dermatologic review of 2-phenoxyethanol when used as a fragrance ingredient is presented. 2-Phenoxyethanol is a member of the fragrance structural group Aryl Alkyl Alcohols and is a primary alcohol. The AAAs are a structurally diverse class of fragrance ingredients that includes primary, secondary, and tertiary alkyl alcohols covalently bonded to an aryl (Ar) group, which may be either a substituted or unsubstituted benzene ring. The common structural element for the AAA fragrance ingredients is an alcohol group -C-(R1)(R2)OH and generically the AAA fragrances can be represented as an Ar-C-(R1)(R2)OH or Ar(_)Alkyl-C-(R1)(R2)OH group. This review contains a detailed summary of all available toxicology and dermatology papers that are related to this individual fragrance ingredient and is not intended as a stand-alone document. Available data for 2-phenoxyethanol were evaluated then summarized and includes physical properties, acute toxicity, skin irritation, mucous membrane (eye) irritation, skin sensitization, elicitation, phototoxicity, photoallergy, toxicokinetics, repeated dose, and reproductive toxicity data. A safety assessment of the entire Aryl Alkyl Alcohols will be published simultaneously with this document; please refer to Belsito et al. (2012) for an overall assessment of the safe use of this material and all Aryl Alkyl Alcohols in fragrances. Belsito, D., Bickers, D., Bruze, M., Calow, P., Dagli, M., Fryer, A.D., Greim, H., Hanifin, J.H., Miyachi, Y., Saurat, J.H., Sipes, I.G., 2012. A toxicologic and dermatologic assessment of aryl alkyl alcohols when used as fragrance ingredients.
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This review deals with the art of (anatomical) embalming. The first part contains a brief historical review of the history of embalming, starting with ancient cultures such as the Egyptians and the lesser known Chinchorro culture, then going down the centuries and describing the anatomical techniques developed over the last two centuries. The second part deals in detail with the chemicals used for embalming purposes. The third part deals with several approaches to evaluating embalming methods, their suitability for biomechanical testing, antimicrobial properties, histological appearance, and usability. The fourth and final part analyze the European Biocidal Products Directive (98/8/EC) in the light of embalming.
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On 10 June 2011, the US National Toxicology Program described formaldehyde as "known to be a human carcinogen". However, formaldehyde is not just a human carcinogen but the cause of other many hazards; respiratory distress, red eyes, etc. Occupational health authorities throughout the world are therefore likely to increase the strictness of regulations for the use of formaldehyde within anatomical disciplines. This study evaluates an alternative for formaldehyde as a preservative for cadavers and human tissues. Tissue samples preserved in 4% formaldehyde were compared with those in 1% Phenoxetol (prefixed in formaldehyde) over a year. Histology slides prepared using Phenoxetol as a preservative were also compared with the conventional ones. The soft consistency, color and flexibility, especially at joints of specimens preserved in Phenoxetol, were found to be suitable for dissection, demonstration and display purposes. Culture of the eleven tissue samples showed no growth after seventy-two h. Microscopic structure of the tissues remained satisfactory when processed with 1% Phenoxetol. Students also found experience with cadavers preserved in phenoxetol very pleasant as it has a fruity smell as compared to the offensive odor of formaldehyde. Phenoxetol is a suitable alternative for the preservation of specimens. However efforts have to be made to reduce or replace the use of formaldehyde as a primary fixative.
Preprint
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Aim of this article is to review the literature about toxic chemicals in cosmetics, to emphasize the importance of toxicological research in cosmetology and to support the campaign for safe cosmetics. There is a need for the establishment of higher standards in cosmetology in a way of raising awareness about toxic chemicals that should be avoided, promoting safer cosmetics and transforming cosmetic industry into safe and non-toxic.
Chapter
In zahlreichen Ländern (z. B. Belgien, Dänemark, Deutschland, Finnland, Schweden, Schweiz und alle osteuropäischen Länder) sind Hände-Desinfektionsmittel Arzneimitteln gleichgestellt und zulassungspflichtig. Daraus ergibt sich, dass sowohl die Wirksamkeit als auch die durch pharmakologisch-toxikologische und klinische Prüfung nachgewiesene Verträglichkeit Voraussetzungen für die Zulassung sind.
Technical Report
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Overall safety assessment of 2-phenoxyethanol Haematotoxicity is a predominant toxicological feature of 2-phenoxyethanol in vivo and in vitro. Comparison of oral studies in rats, mice and rabbits indicates that rabbits are the test species most sensitive to haematotoxic effects by 2-phenoxyethanol. The main metabolite 2-phenoxyacetic acid is formed in rabbit liver at much lower rates than in humans > rats > mice. Rabbit erythrocytes were found less resistant to 2-phenoxyethanol toxicity than erythrocytes from humans > rats > mice, whereas 2-phenoxyacetic acid did not show a haematotoxic potential. Systemic availability of 2-phenoxyethanol after oral exposure of rats is very low due to a strong first pass effect in rat liver and the rapid formation of the main metabolite 2-phenoxyacetic acid, which may accumulate in the kidney and may be responsible for kidney toxicity in rats after oral exposure. In contrast, dermal exposure of rats to 2-phenoxyethanol revealed much higher concentrations of the parent compound in blood than after oral exposure. This may also be true for other species such as humans. For these reasons and because dermal exposure is the relevant route of exposure of humans to 2-phenoxyethanol in cosmetic products, preference is given to dermal studies in rabbits, the most sensitive species tested, whereas the oral route is considered of questionable relevance. Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits, the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol. Using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits and the aggregate exposure for preservatives in cosmetics, for adult humans a MoS of 130 was derived. The large span of this MoS to the MoS of 25 selected by the SCCS for the safety assessment also covers the safety of infants and babies to 2-phenoxyethanol exposure in cosmetic products. CONCLUSION 1. Does SCCS consider Phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0 %, taking into account the information provided? The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%, taking into account the information provided. 2. The SCCS is asked, when making the assessment, to take into account the specific age groups who might be particularly susceptible to the effects of Phenoxyethanol used as preservatives in cosmetic products. The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol. Therefore, the MoS of about 50 for children also covers this specific age group who might be higher exposed to 2-phenoxyethanol than adults. 3. Does the SCCS have any further scientific concerns with regard to the use of Phenoxyethanol in cosmetic products? This Opinion does not take into account exposure from sources other than cosmetics.
Technical Report
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Conclusion of the opinion: (1)Does SCCS consider Phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0 %, taking into account the information provided? The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%, taking into account the information provided. (2) The SCCS is asked, when making the assessment, to take into account the specific age groups who might be particularly susceptible to the effects of Phenoxyethanol used as preservatives in cosmetic products. The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol. Therefore, the MoS of about 50 for children also covers this specific age group who might be higher exposed to 2-phenoxyethanol than adults. (3) Does the SCCS have any further scientific concerns with regard to the use of Phenoxyethanol in cosmetic products? This Opinion does not take into account exposure from sources other than cosmetics. Keywords: SCCS, scientific opinion, Phenoxyethanol, Regulation 1223/2009, CAS No. 122-99-6, EC No. 204-589-7
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Phenoxyethanol is a preservative used extensively in cosmetics and pharmaceutical products for its antibacterial and antifugal properties. Despite its widespread use, it is a rare cause of delayed and immediate contact reactions. We report a case of contact urticaria after using an ultrasound gel containing phenoxyethanol. This article is protected by copyright. All rights reserved.
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Aim is to review the literature about toxic chemicals in cosmetics.
Conference Paper
Cosmetics formulations used to enhance the human appearance are popular since ages and herbal, natural based cosmetics are gaining more attention recently. This increased attention is because of their non-toxic, safe perception. In this present research we had formulated herbal cream possessing the properties of moisturizing, nourishing, lightening and treating various skin ailments. Different Schiff base active ingredients, N-(4-methoxybenzylidine aniline), Montanova-68, Glycerin monostearate, Coconut oil, Glycerin, citric acid and perfume orange fresh were taken, stability testing of final sample has been conducted in the environmental chamber with temperature 25 ± 2°C and humidity 60 ± 5 % RH. All the products were found to be stable with no signs of phase separation and no change in the color. The patch test for sensitivity testing has also been done and no evidence of skin irritation and allergic signs were reported. The current work bases mainly on the assessment of the microbial quality of formulated cosmetic preparations. All the prepared novel formulations were found to comply with the stated cosmeceutical guidelines. Thus, herbal cosmetics formulation is proved to be safe for human usewith notable performance properties for skin-health improvement.
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The activity of the antimicrobial preservatives, phenoxyethanol and thiomersal, were compared in diphtheria, tetanus and pertussis (adsorbed) vaccine. Both chemicals were equally effective in inactivating challenge doses of Gram-negative and Gram-positive micro-organisms, as well as a yeast.
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Using a modified FCA (Freund's complete adjuvant) procedure, the sensitizing capacity of Euxyl K 400 and its ingredients, 1,2-dibromo-2,4-dicyanobutane and 2-phenoxyethanol, has been studied in guinea pigs. The experiments demonstrate that a distinct but weak sensitizing potency exists for Euxyl K 400 and dibromodicyanobutane. Phenoxyethanol remained almost negative. These results are in good accordance with the low number of cases of allergic contact dermatitis due to Euxyl K 400 and dibromodicyanobutane described since their introduction on the market. Cases of phenoxyethanol contact allergy have been published hitherto only 4x in the medical literature.
Article
Preservatives are biologically reactive substances, and their allergenic potential has been known for a long time. This study examined the role of different preservatives in a large number of patients with suspected allergic contact dermatitis. Patch test data and data from the patients' history were collected from the 24 departments participating in the Information Network of Departments of Dermatology from 1 January 1990 to 31 December 1994. Patch test data from 28,349 patients tested with preservatives of the standard series (SS), from 11,485 patients tested additionally with a preservative series (PS), and from 1787 patients tested with an industrial biocide tray (IB) were evaluated. Sensitization rates (standardized) of the SS preservatives were all > 1%, with thiomersal rating highest (5.3%), the parabens lowest (1.6%), and the remainder (chlormethylisothiazolinone/methylisothiazolinone, formaldehyde and methyldibromoglutaronitrile/phenoxyethanol (MDBGN/PE)) in the range of 2%. The most important allergens of the PS were, in women, alkylaminobenzoate (contained in milking fat) (2.5%), MDBGN/PE (2.2%), benzalkonium chloride (1.8%), chloracetamide (1.4%), diazolidinyl urea (1.3%), octylgallate (1.2%) and Bronopol (1.1%). In men rates differed only with regard to alkylaminobenzoate (0.9%). Patients tested with the IB series reacted most often to methylene-bis-thiocyanate (5%), but with a reaction index of -0.7, many reactions were most probably false positives. A further seven preservatives, mostly formaldehyde-releasers used in cutting fluids, gave sensitization rates of between 1% and 3%. Glutaraldehyde, not contained in the series but often tested additionally, showed a remarkable increase in sensitization during the study period. Health care personnel were frequently affected. Altogether, this study identified areas of concern within the different groups of preservatives. The overall impact of most of the preservatives on public health seems to be low, but for diagnostic reasons preservatives must be included in patch test series.
Patch testing with preservatives, antimicrobials and industrial biocides
  • Schnuch A
  • J Geier
  • Frosch Uter W
  • Pj
SCHNUCH A, GEIER J, UTER W, FROSCH PJ. Patch testing with preservatives, antimicrobials and industrial biocides. Results from a multicentre study. Br J Dermatol 1998;138:467-476.
Catilina Key words: antioxidants
  • L Fontana
  • C Gaudez
  • G Garde
L. Fontana*, C. Gaudez, G. Garde, P. Catilina Key words: antioxidants; p-phenylenediamine compounds; rubber; rubber industry.