E216
Rating : 5.5
Evaluation | N. Experts | Evaluation | N. Experts |
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1 | 6 | ||
2 | 7 | ||
3 | 8 | ||
4 | 9 | ||
5 | 10 |
Cons:
Possible risk. Click ingredient (1)7 pts from Ark90
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"Propylparaben studies" about E216 Review Consensus 8 by Ark90 (12417 pt) | 2022-Nov-18 12:06 |
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The most relevant studies and their abstracts have been selected to explore this in more depth:
Ball AL, Solan ME, Franco ME, Lavado R. Comparative cytotoxicity induced by parabens and their halogenated byproducts in human and fish cell lines. Drug Chem Toxicol. 2022 Jul 19:1-9. doi: 10.1080/01480545.2022.2100900.
Abstract. Parabens are a group of para-hydroxybenzoic acid (p-HBA) esters widely used in pharmaceutical industries. Their safety is well documented in mammalian models, but little is known about their toxicity in non-mammal species. In addition, chlorinated and brominated parabens resulting from wastewater treatment have been identified in effluents. In the present study, we explored the cytotoxic effects (EC50) of five parabens: methylparaben (MP), ethylparaben (EP), propylparaben (PP), butylparaben (BuP), and benzylparaben (BeP); the primary metabolite, 4-hydroxybenzoic acid (4-HBA), and three of the wastewater chlorinated/brominated byproducts on fish and human cell lines. In general, higher cytotoxicity was observed with increased paraben chain length. The tested compounds induced toxicity in the order of 4-HBA < MP < EP < PP < BuP < BeP. The halogenated byproducts led to higher toxicity with the addition of second chlorine. The longer chain-parabens (BuP and BeP) caused a concentration-dependent decrease in cell viability in fish cell lines. Intriguingly, the main paraben metabolite, 4-HBA, proved to be more toxic to fish hepatocytes than human hepatocytes by 100-fold. Our study demonstrated that the cytotoxicity of some of these compounds appears to be tissue-dependent. These observations provide valuable information for early cellular responses in human and non-mammalian models upon exposure to paraben congeners.
Kolatorova L, Sramkova M, Vitku J, Vcelak J, Lischkova O, Starka L, Duskova M. Parabens and their relation to obesity. Physiol Res. 2018 Nov 28;67(Suppl 3):S465-S472. doi: 10.33549/physiolres.934004.
Abstract. Parabens are a group of chemicals used as preservatives in the food, cosmetic and pharmaceutical industries. They are known to possess estrogenic effects, and therefore have been classified as endocrine disruptors. In addition to the classical endocrine organs, other tissues have endocrine activity, including adipose tissue. Several chemicals are known to cause obesogenic effects, and parabens are currently being studied in this context. The aim of this study was to investigate the possible connections of paraben exposure and obesity. Blood plasma from 27 healthy women was collected during their menstrual cycle. Basal anthropometric measures, levels of parabens (methylparaben, ethylparaben and propylparaben), adipokines (adiponectin, adipsin, leptin, resistin and visfatin) and hormones affecting energy balance and metabolic health (c-peptide, ghreline, GIP, GLP-1, glucagon, insulin, PAI-1) were measured. A Kolmogorov-Smirnov test showed higher methylparaben and propylparaben levels in women with BMI 25-34.9 compared to those with BMI 18.5-24.9. Plasma levels of methylparaben as well as the sum of parabens were positively associated with the plasma adipsin levels. Negative associations for methylparaben were found for glucagon, leptin and PAI-1. In accordance with other experimental studies we observed important associations of methylparaben and hormones affecting energy balance and metabolic health, indicating its obesogenic potential.
Torres T, Cunha I, Martins R, Santos MM. Screening the Toxicity of Selected Personal Care Products Using Embryo Bioassays: 4-MBC, Propylparaben and Triclocarban. Int J Mol Sci. 2016 Oct 21;17(10):1762. doi: 10.3390/ijms17101762.
Abstract. Recently, several emerging pollutants, including Personal Care Products (PCPs), have been detected in aquatic ecosystems, in the ng/L or µg/L range. Available toxicological data is limited, and, for certain PCPs, evidence indicates a potential risk for the environment. Hence, there is an urgent need to gather ecotoxicological data on PCPs as a proxy to improve risk assessment. Here, the toxicity of three different PCPs (4-Methylbenzylidene Camphor (4-MBC), propylparaben and triclocarban) was tested using embryo bioassays with Danio rerio (zebrafish) and Paracentrotus lividus (sea urchin). The No Observed Effect Concentration (NOEC) for triclocarban was 0.256 µg/L for sea urchin and 100 µg/L for zebrafish, whereas NOEC for 4-MBC was 0.32 µg/L for sea urchin and 50 µg/L for zebrafish. Both PCPs impacted embryo development at environmentally relevant concentrations. In comparison with triclocarban and 4-MBC, propylparaben was less toxic for both sea urchin (NOEC = 160 µg/L) and zebrafish (NOEC = 1000 µg/L). Overall, this study further demonstrates the sensitivity of embryo bioassays as a high-throughput approach for testing the toxicity of emerging pollutants.
Vandenberg LN, Bugos J. Assessing the Public Health Implications of the Food Preservative Propylparaben: Has This Chemical Been Safely Used for Decades. Curr Environ Health Rep. 2021 Mar;8(1):54-70. doi: 10.1007/s40572-020-00300-6.
Abstract. Purpose: Parabens are chemicals containing alkyl-esters of p-hydroxybenzoic acid, which give them antimicrobial, antifungal, and preservative properties. Propylparaben (PP) is one paraben that has been widely used in personal care products, cosmetics, pharmaceuticals, and food. In this review, we address the ongoing controversy over the safety of parabens, and PP specifically. These chemicals have received significant public attention after studies published almost 20 years ago suggested plausible associations between PP exposures and breast cancer. Recent findings: Here, we use key characteristics, a systematic approach to evaluate the endocrine disrupting properties of PP based on features of "known" endocrine disruptors, and consider whether its classification as a "weak" estrogen should alleviate public health concerns over human exposures. We also review the available evidence from rodent and human studies to illustrate how the large data gaps that exist in hazard assessments raise concerns about current evaluations by regulatory agencies that PP use is safe. Finally, we address the circular logic that is used to suggest that because PP has been used for several decades, it must be safe. We conclude that inadequate evidence has been provided for the safe use of PP in food, cosmetics, and consumer products.
Mogus JP, LaPlante CD, Bansal R, Matouskova K, Schneider BR, Daniele E, Silva SJ, Hagen MJ, Dunphy KA, Jerry DJ, Schneider SS, Vandenberg LN. Exposure to Propylparaben During Pregnancy and Lactation Induces Long-Term Alterations to the Mammary Gland in Mice. Endocrinology. 2021 Jun 1;162(6):bqab041. doi: 10.1210/endocr/bqab041.
Abstract. The mammary gland is a hormone sensitive organ that is susceptible to endocrine-disrupting chemicals (EDCs) during the vulnerable periods of parous reorganization (ie, pregnancy, lactation, and involution). Pregnancy is believed to have long-term protective effects against breast cancer development; however, it is unknown if EDCs can alter this effect. We examined the long-term effects of propylparaben, a common preservative used in personal care products and foods, with estrogenic properties, on the parous mouse mammary gland. Pregnant BALB/c mice were treated with 0, 20, 100, or 10 000 µg/kg/day propylparaben throughout pregnancy and lactation. Unexposed nulliparous females were also evaluated. Five weeks post-involution, mammary glands were collected and assessed for changes in histomorphology, hormone receptor expression, immune cell number, and gene expression. For several parameters of mammary gland morphology, propylparaben reduced the effects of parity. Propylparaben also increased proliferation, but not stem cell number, and induced modest alterations to expression of ERα-mediated genes. Finally, propylparaben altered the effect of parity on the number of several immune cell types in the mammary gland. These results suggest that propylparaben, at levels relevant to human exposure, can interfere with the effects of parity on the mouse mammary gland and induce long-term alterations to mammary gland structure. Future studies should address if propylparaben exposures negate the protective effects of pregnancy on mammary cancer development. © The Author(s) 2021.
Li C, Chen X. Parabens in indoor dust from houses, university dormitories, and cosmetics stores in Nanjing, China: occurrence and human exposure. Environ Sci Pollut Res Int. 2022 Nov 14. doi: 10.1007/s11356-022-24137-8.
Abstract. Parabens are extensively used as preservatives in consumer products. The widespread exposure of human to parabens has been associated with adverse health effects. In this study, six parabens were measured in 100 indoor dust collected from homes, university dormitories, and cosmetics stores in Nanjing, China. Concentrations of sum of six parabens (∑6parabens) in dust from homes, university dormitories, and cosmetics stores ranged from 13.1 to 4.22 × 103, 102 to 3.03 × 103, and 7.02 × 103 to 3.41 × 104 ng/g, respectively. The median concentrations of ∑6parabens in dust from cosmetics stores (1.5 × 104 ng/g) were 1-2 orders of magnitude higher than those found in dust from homes (166 ng/g) and university dormitories (1.23 × 103 ng/g) (p < 0.01). Methyl-, ethyl-, and propyl-parabens were the predominant compounds found in dust samples, and the sum concentrations of three compounds accounted for 71.9-99.6%, 93.1-99.6%, and 94.7-99.6% of ∑6parabens in dust from homes, university dormitories, and cosmetics stores, respectively. Significant positive correlations were found between methyl- and propyl-parabens concentrations in three types of dust (r = 0.789-0.909), indicating their coexistence in many consumer products. The estimated daily intake (EDI) of ∑6parabens for adults via dust ingestion was highest for employees in cosmetics stores (median: 4.6 ng/kg bw/day), followed by university students (0.56-0.64 ng/kg bw/day), and adults in homes (0.075-0.087 ng/kg bw/day). The result provides a better understanding of human exposure to parabens in different indoor environments, and more studies are needed to further investigate the occurrence and potential health risks of parabens in dust from various microenvironments. © 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Shin MY, Choi JW, Lee S, Kim S, Kho Y, Choi K, Kim S. Pharmacokinetics of transdermal methyl-, ethyl-, and propylparaben in humans following single dermal administration. Chemosphere. 2023 Jan;310:136689. doi: 10.1016/j.chemosphere.2022.136689.
Abstract. Parabens are common chemicals used as preservatives in foods, cosmetics, and personal care products. Although transdermal exposure to parabens occurs, studies on human pharmacokinetics (PK) following dermal exposure to parabens are scarce. In this study, the PK following dermal exposure to parabens was determined and compared with our previous findings on oral exposure. Copyright © 2022 The Authors.
Lara-Valderrábano L, Rocha L, Galván EJ. Propylparaben reduces the excitability of hippocampal neurons by blocking sodium channels. Neurotoxicology. 2016 Dec;57:183-193. doi: 10.1016/j.neuro.2016.09.019.
Abstract. Propylparaben (PPB) is an antimicrobial preservative widely used in food, cosmetics, and pharmaceutics. Virtual screening methodologies predicted anticonvulsant activity of PPB that was confirmed in vivo. Thus, we explored the effects of PPB on the excitability of hippocampal neurons by using standard patch clamp techniques. Bath perfusion of PPB reduced the fast-inactivating sodium current (INa) amplitude, causing a hyperpolarizing shift in the inactivation curve of the INa, and markedly delayed the sodium channel recovery from the inactivation state. Also, PPB effectively suppressed the riluzole-sensitive, persistent sodium current (INaP). PPB perfusion also modified the action potential kinetics, and higher concentrations of PPB suppressed the spike activity. Nevertheless, the modulatory effects of PPB did not occur when PPB was internally applied by whole-cell dialysis. These results indicate that PPB reduces the excitability of CA1 pyramidal neurons by modulating voltage-dependent sodium channels. The mechanistic basis of this effect is a marked delay in the recovery from inactivation state of the voltage-sensitive sodium channels. Our results indicate that similar to local anesthetics and anticonvulsant drugs that act on sodium channels, PPB acts in a use-dependent manner. Copyright © 2016 Elsevier B.V.
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"Descrizione" about E216 Review Consensus 7 by Ark90 (12417 pt) | 2023-Dec-10 12:19 |
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E216 (Propylparaben) is a chemical compound, benzoate propyl ester of 4-hydroxybenzoic acid, and belongs to the chemical family of parabens.
Security. Foreword
Although this allergen is less and less used, warning must be given because it is labelled under different nomenclature, with different names corresponding to its many synonyms.
In 2014, the European Union banned the use of iso-propyl paraben, iso-butyl paraben, benzyl paraben, and pentyl paraben in cosmetics and iso-propyl paraben in food products, while the use of methylparaben and ethylparaben (EtP) is limited to a maximum of 0.4% per single compound and 0.8% per mixture of esters. o single ester.
In this study on the elderly population in the United States, exposure to parabens was positively associated with low cognitive performance in older male subjects (1) and with oestrogenic activity (e.g. water retention) and therefore being evaluated as endocrine disrupters (2).
The name describes the structure of the molecule:
Industrially it appears as a white crystalline powder. Stable, incompatible with strong oxidising agents and strong bases.
What it is used for and where
Food
Antimicrobial preservative. It is labelled with the number E216 in the list of European food additives as a preservative and serves to fight bacteria, fungi, yeasts and moulds, however, it has been found in numerous clinical studies to have an endocrine disrupting effect. Although this allergen is used less and less, warning must be given because it is written on labels under different nomenclature, with different names corresponding to its many synonyms.
So beware of cumulative intake.
Cosmetics
It is a restricted ingredient as V/12 a Relevant Item in the Annexes of the European Cosmetics Regulation 1223/2009.
Preservative. Any product containing organic, inorganic compounds, water, needs to be preserved from microbial contamination. Preservatives act against the development of harmful microorganisms and against oxidation of the product.
Antimicrobial preservative belonging to the paraben family, a class of chemical compounds to which the scientific literature attributes endocrine disrupting characteristics. Although this allergen is less and less used, warning must be given because it is written on labels under different nomenclature, with different names corresponding to its many synonyms. It is currently regulated as a preservative in concentrations up to 0.14% (as an acid) and 'the current level of evidence is insufficient to consider it an endocrine disruptor or to derive a toxicological starting point based on its endocrine disrupting properties' (3) and so far the experts' study appears reassuring, however the overall cumulative intake of parabens for those who use many creams or body care products containing parabens must be considered. The endocrine system hinges on the interactive balancing act between hormones, and disruption of this delicate balance can lead to increased intracellular oestrogen levels in adipocytes, in effect enhancing obesity throughout the body or in certain parts of the body. Clinical studies recommend avoiding exposure to endocrine disruptors to reduce weight (Darbre 2017). Parabens can enter the human body through ingestion, absorption through the skin or inhalation. And this is where cumulation can come into play.
Perfuming. Unlike fragrance, which can also contain slightly less pleasant or characteristic odours, the term perfume indicates only very pleasant fragrances. Used for perfumes and aromatic raw materials.
Medical
The news about Propylparaben is not so worrying in medical terms, but has provided grounds for study for specific applications. At controlled doses this preservative has shown protective activity in severe traumatic brain injury (4) and could represent a new therapeutic strategy in drug-resistant spontaneous recurrent seizures of the epileptic state (5).
The most relevant studies and their abstracts have been selected to explore this in more depth:
Appearance | White powder |
Boiling Point | 294.3±13.0°C at 760 mmHg |
Melting Point | 95-98°C |
Flash Point | 124.6±12.6°C |
Density | 1.1±0.1 g/cm3 |
Refraction Index | 1.532 |
Vapor Pressure | 0.0±0.6 mmHg at 25°C |
Water Solubility | <0.1 g/100 mL at 12ºC |
PSA | 46.53000 |
LogP | 2.93 |
Loss on drying | ≤0.5% |
Residue on ignition | ≤0.1% |
Sulphated Ash | 0.1% max |
Sulfate So42- | 0.024%Max |
Residue | 0.05% max |
Heavy Metal | 10 ppm max |
Acidity | <0.1 |
P-hydroxybenzoic acid | ≤0.50% |
Single impurities | ≤0.50% |
Heavy Metal Pb | ≤1.0% |
Specific Gravity | 0.789 (20/4℃) |
Storage | 0-6°C |
Synonyms:
References________________________________________________________________________
(1) Shi Y, Wang H, Zhu Z, Ye Q, Lin F, Cai G. Association between exposure to phenols and parabens and cognitive function in older adults in the United States: A cross-sectional study. Sci Total Environ. 2022 Nov 9:160129. doi: 10.1016/j.scitotenv.2022.160129.
(2) Aline Murawski, Carolin Tschersich, Enrico Rucic, Gerda Schwedler, Rebecca K. Moos, Monika Kasper-Sonnenberg, Thomas Brüning, Holger M. Koch, Marike Kolossa-Gehring, Parabens in urine of children and adolescents in Germany – human biomonitoring results of the german environmental survey 2014–2017 (GerES V), Environmental Research, Volume 194, 2021, 110502, ISSN 0013-9351, https://doi.org/10.1016/j.envres.2020.110502. (https://www.sciencedirect.com/science/article/pii/S0013935120313992) Abstract: Parabens are antimicrobial preservatives used in a wide range of consumer products such as personal care products, cosmetics, pharmaceuticals, and food. Consequently, the general population is ubiquitously exposed to these substances via dermal absorption, ingestion, and inhalation. Parabens promote estrogenic activity and are hence under assessment as endocrine disrupting substances. Urine samples from 3- to 17-year-old children and adolescents (N = 516) living in Germany were analysed for concentrations of nine parabens in the population representative German Environmental Survey for Children and Adolescents 2014–2017 (GerES V). Detection rates and urinary concentrations of the parabens decreased with increasing length of the alkyl chain. Methyl paraben was quantified in 97% of the samples with a geometric mean (GM) concentration of 7.724 μg/L (6.714 μg/gcreatinine), ethyl paraben was quantified in 69% (GM: 0.943 μg/L and 0.825 μg/gcrea), and n-propyl paraben in 31% (GM: 0.563 μg/L and 0.493 μg/gcrea). Concentrations of iso-propyl paraben, butyl paraben, iso-butyl paraben, and benzyl paraben were below the limit of quantification in most samples. Pentyl paraben and heptyl paraben were not detected in any of the samples. Paraben concentrations in urine were found to be associated with frequent usage of leave-on personal care products and cosmetics. Cumulative exposure to parabens (back-calculated daily intakes, expressed as hazard index) was found to be on a level raising concern in up to 14% of the population, mainly driven by n-propyl paraben, and depending on the level of conservativeness and point-of departures used for calculation.
(3) SCCS Members. Electronic address: SANTE-C2-SCCS@ec.europa.eu; SCCS External Experts; SCCS Members. Opinion of the Scientific Committee on Consumer Safety (SCCS) - Final Opinion on propylparaben (CAS No 94-13-3, EC No 202-307-7). Regul Toxicol Pharmacol. 2021 Oct;125:105005. doi: 10.1016/j.yrtph.2021.105005.
(4) Santiago-Castañeda C, Segovia-Oropeza M, Concha L, Orozco-Suárez SA, Rocha L. Propylparaben Reduces the Long-Term Consequences in Hippocampus Induced by Traumatic Brain Injury in Rats: Its Implications as Therapeutic Strategy to Prevent Neurodegenerative Diseases. J Alzheimers Dis. 2021;82(s1):S215-S226. doi: 10.3233/JAD-200914.
(5) Santana-Gómez CE, Valle-Dorado MG, Domínguez-Valentín AE, Hernández-Moreno A, Orozco-Suárez S, Rocha L. Neuroprotective effects of levetiracetam, both alone and combined with propylparaben, in the long-term consequences induced by lithium-pilocarpine status epilepticus. Neurochem Int. 2018 Nov;120:224-232. doi: 10.1016/j.neuint.2018.09.004.
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Component type:   Chemical Main substances:   Parabens Last update:   2023-06-21 10:53:25 | Chemical Risk:   Irritant |