-
Journal of the European Academy of... Nov 2019Phenoxyethanol, 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... (Review)
Review
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.
Topics: Animals; Biological Availability; Carcinogens; Cosmetics; Dermatitis, Allergic Contact; Endocrine Disruptors; Ethylene Glycols; Humans; Nervous System Diseases; Preservatives, Pharmaceutical; Reproduction; Skin Absorption
PubMed: 31588615
DOI: 10.1111/jdv.15944 -
Molecules (Basel, Switzerland) Jun 2018Cosmetics, like any product containing water and organic/inorganic compounds, require preservation against microbial contamination to guarantee consumer’s safety and... (Review)
Review
Cosmetics, like any product containing water and organic/inorganic compounds, require preservation against microbial contamination to guarantee consumer’s safety and to increase their shelf-life. The microbiological safety has as main goal of consumer protection against potentially pathogenic microorganisms, together with the product’s preservation resulting from biological and physicochemical deterioration. This is ensured by chemical, physical, or physicochemical strategies. The most common strategy is based on the application of antimicrobial agents, either by using synthetic or natural compounds, or even multifunctional ingredients. Current validation of a preservation system follow the application of good manufacturing practices (GMPs), the control of the raw material, and the verification of the preservative effect by suitable methodologies, including the challenge test. Among the preservatives described in the positive lists of regulations, there are parabens, isothiasolinone, organic acids, formaldehyde releasers, triclosan, and chlorhexidine. These chemical agents have different mechanisms of antimicrobial action, depending on their chemical structure and functional group’s reactivity. Preservatives act on several cell targets; however, they might present toxic effects to the consumer. Indeed, their use at high concentrations is more effective from the preservation viewpoint being, however, toxic for the consumer, whereas at low concentrations microbial resistance can develop.
Topics: Anti-Infective Agents; Cosmetics; Preservation, Biological; Preservatives, Pharmaceutical
PubMed: 29958439
DOI: 10.3390/molecules23071571 -
Eye (London, England) Feb 2022Preservatives in multidose formulations of topical ophthalmic medications are crucial for maintaining sterility but can be toxic to the ocular surface. Benzalkonium... (Review)
Review
Preservatives in multidose formulations of topical ophthalmic medications are crucial for maintaining sterility but can be toxic to the ocular surface. Benzalkonium chloride (BAK)-used in approximately 70% of ophthalmic formulations-is well known to cause cytotoxic damage to conjunctival and corneal epithelial cells, resulting in signs and symptoms of ocular surface disease (OSD) including ocular surface staining, increased tear break-up time, and higher OSD symptom scores. These adverse effects are more problematic with chronic exposure, as in lifetime therapy for glaucoma, but can also manifest after exposure as brief as seven days. Multiple strategies are available to minimize or eliminate BAK exposure, among them alternative preservatives, preservative-free formulations including sustained release drug delivery platforms, and non-pharmacological therapies for common eye diseases and conditions. In this paper, we review the cytotoxic and clinical effects of BAK on the ocular surface and discuss existing and emerging options for ocular disease management that can minimize or eliminate BAK exposure.
Topics: Antihypertensive Agents; Benzalkonium Compounds; Glaucoma; Humans; Ophthalmic Solutions; Preservatives, Pharmaceutical
PubMed: 34262161
DOI: 10.1038/s41433-021-01668-x -
JAMA Feb 2022
Topics: Dry Eye Syndromes; Humans; Lubricant Eye Drops; Preservatives, Pharmaceutical; Tears
PubMed: 35103781
DOI: 10.1001/jama.2021.19963 -
Eye & Contact Lens Sep 2018Toxic keratoconjunctivitis (TK) is an underrecognized complication of ophthalmic drug use and various environmental or occupational exposures. A detailed history and... (Review)
Review
Toxic keratoconjunctivitis (TK) is an underrecognized complication of ophthalmic drug use and various environmental or occupational exposures. A detailed history and clinical examination are important to identify the offending agent(s). Common drug-related causes of TK include preservatives in ophthalmic medications, topical antimicrobials, and topical anesthetics. Alternatives to benzalkonium chloride as well as preservative-free formulations should be considered in patients requiring long-term topical medication. More advanced cases of TK may require preservative-free topical steroids and/or antibiotics, and occasionally surgical intervention. Early recognition and appropriate management of TK may help prevent permanent ocular and visual damage.
Topics: Anesthetics; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Benzalkonium Compounds; Humans; Keratoconjunctivitis; Ophthalmic Solutions; Preservatives, Pharmaceutical
PubMed: 28445208
DOI: 10.1097/ICL.0000000000000392 -
Journal of Preventive Medicine and... Mar 2019Cosmetic products contain a wide range of chemicals to which we are exposed every day. The aim of the study was to determine the presence of potential dangerous...
INTRODUCTION
Cosmetic products contain a wide range of chemicals to which we are exposed every day. The aim of the study was to determine the presence of potential dangerous substances which can cause adverse health effects by examining product labels.
MATERIALS AND METHODS
A total of 283 products were collected from various shops in Lecce (Italy) and divided into 3 categories: rinse-off, leave-on and make-up. The label of every product was examined and a list including fragrances, preservatives and other chemicals of concern was created.
RESULTS
Fragrances were present in 52.3% of the examined products, mostly limonene (76.9%) and linalool (64.6%) but also citronellol (34.1%), geraniol (31.5%), coumarin (30%) and hexyl cinnamal (29.2%). Preservatives showed a rate of 60% and the most frequently identified were phenoxyethanol (48.7%), sodium benzoate (35.6%), potassium sorbate (22%), methylparaben (15.2%) and MI/MCI (9.9%). The other chemicals of concern were detected in 58% of products; included PEGs (62.3%), acrylate copolymer (34%), petrolatum (17.2%), polysorbates (14,8%), BHT (14.7%), ethylhextyl methoxycinnamate (13.6%), benzophenone-1 (3.7%), benzophenone-3 (4.9%), BHA (1.6%), cocamide DEA and toluene (1.2%).
CONCLUSIONS
The use of many of these substances is allowed within certain limits, due to their toxicity at higher concentrations. Other important aspects should be considered as, for instance, the possibility of long-term effects. On the other hand, other substances may induce several acute adverse side-effects, i.e. contact dermatitis and allergic reactions. For these reasons, an enhancement of the criteria used for cosmetics formulation is required since many chemicals used singularly or combined are potentially unsafe.
Topics: Allergens; Cosmetics; Humans; Odorants; Preservatives, Pharmaceutical; Skin Diseases
PubMed: 31041411
DOI: 10.15167/2421-4248/jpmh2019.60.1.1080 -
Contact Dermatitis Nov 2016
Topics: Consumer Product Safety; Dermatitis, Allergic Contact; Europe; Humans; Preservatives, Pharmaceutical; Product Labeling; Thiazoles
PubMed: 27709707
DOI: 10.1111/cod.12705 -
Dermatitis : Contact, Atopic,... 2019Parabens have been widely used as preservatives in the cosmetics, food, and pharmaceutical industries for more than 70 years. Monitoring for paraben allergy closely... (Review)
Review
Parabens have been widely used as preservatives in the cosmetics, food, and pharmaceutical industries for more than 70 years. Monitoring for paraben allergy closely followed with studies reporting paraben testing in standard screening fashion as early as 1940. The frequency of sensitivity to this widely used biocide has remained low and remarkably stable for many decades despite extensive use and progressive expansion of utilization worldwide. The authors select paraben mix as the (non)allergen of the year. Paraben reactions are quite uncommon and generally relevant. Parabens remain one of the least allergenic preservatives available. The unsubstantiated public perception of paraben safety has led to its replacement in many products with preservatives having far greater allergenic potential. This report reviews the well-established safety of parabens from an allergologic standpoint.
Topics: Cosmetics; Dermatitis, Allergic Contact; Food Preservatives; Humans; Immunization; Parabens; Patch Tests; Preservatives, Pharmaceutical
PubMed: 30570578
DOI: 10.1097/DER.0000000000000429 -
Dermatitis : Contact, Atopic,... 2019Parabens now being formally declared as the American Contact Dermatitis Society (non)allergen of the year, the allergologic concerns regarding parabens raised during the... (Review)
Review
Parabens now being formally declared as the American Contact Dermatitis Society (non)allergen of the year, the allergologic concerns regarding parabens raised during the past century are no longer a significant issue. The more recent toxicological concerns regarding parabens are more imposing, stemming from the gravity of the noncutaneous adverse health effects for which they have been scrutinized for the past 20 years. These include endocrine activity, carcinogenesis, infertility, spermatogenesis, adipogenesis, perinatal exposure impact, and nonallergologic cutaneous, psychologic, and ecologic effects. To assert that parabens are safe for use as currently used in the cosmetics, food, and pharmaceutical industries, all toxicological end points must be addressed. We seek to achieve perspective through this exercise: perspective for the professional assessing systemic risk of parabens by all routes of exposure. The data reviewed in this article strive to provide a balanced perspective for the consumer hopefully to allay concerns regarding the safety of parabens and facilitate an informed decision-making process. Based on currently available scientific information, claims that parabens are involved in the genesis or propagation of these controversial and important health problems are premature. Haste to remove parabens from consumer products could result in their substitution with alternative, less proven, and potentially unsafe alternatives, especially given the compelling data supporting the lack of significant dermal toxicity of this important group of preservatives.
Topics: Adipogenesis; Androgen Antagonists; Breast Neoplasms; Endocrine Disruptors; Environmental Pollution; Estrogens; Female; Humans; Infertility; Male; Parabens; Pregnancy; Prenatal Exposure Delayed Effects; Preservatives, Pharmaceutical; Skin Neoplasms; Spermatogenesis
PubMed: 30570577
DOI: 10.1097/DER.0000000000000428 -
The British Journal of Ophthalmology Nov 2018Preservatives continue to be in widespread use in ophthalmic medications due to the convenience they provide, regulatory requirements and the higher cost of... (Review)
Review
Preservatives continue to be in widespread use in ophthalmic medications due to the convenience they provide, regulatory requirements and the higher cost of alternatives. Benzalkonium chloride (BAK) remains the most commonly used preservative but there is a trend towards the use of preservative-free (PF) drops for glaucoma, although at a higher price. An extensive body of literature explores BAK toxicity on ocular structures in animal and laboratory studies (in vitro and in vivo). Non-randomised controlled studies have provided some supporting evidence of its toxicity in patients, especially in those with pre-existing ocular surface disease (OSD) or on multiple medications. However, there have been very few randomised controlled trials that compare the same medication with and without BAK preservative. Several of these trials have never been published in any peer reviewed journals. Notwithstanding, those that have been published, have not demonstrated any clear benefits of the BAK-free formulations. Short duration and exclusion of those with OSD are limitations of these studies. There is a lack of evidence of clinically significant harm from a small number of BAK preserved drops in patients without OSD. This means that generally more expensive PF glaucoma medications should only be recommended for those on poly pharmacy or those with OSD but are not necessarily required for all patients.
Topics: Anterior Eye Segment; Antihypertensive Agents; Glaucoma; Humans; Ophthalmic Solutions; Preservatives, Pharmaceutical
PubMed: 29973365
DOI: 10.1136/bjophthalmol-2017-311544