Ethylparaben

The Basics On Ethylparaben

What is Ethylparaben?

A type of paraben, part of the group of controversial preservatives.

What are other names for Ethylparaben?

4-HYDROXY- ETHYL ESTER BENZOIC ACID, 4-HYDROXYBENZOIC ACID, ETHYL ESTER, 4-HYDROXYBENZOIC ACID, ETHYL ESTER, SODIUM SALT, BENZOIC ACID, 4-HYDROXY-, ETHYL ESTER, BENZOIC ACID, 4-HYDROXY-, ETHYL ESTER, SODIUM SALT, BENZOIC ACID, 4HYDROXY, ETHYL ESTER, BENZOIC ACID, 4HYDROXY, ETHYL ESTER, SODIUM SALT, ETHYL 4-HYDROXYBENZOATE, ETHYL ESTER 4-HYDROXYBENZOIC ACID, ETHYL ESTER BENZOIC ACID, 4-HYDROXY-, ETHYL ESTER SODIUM SALT 4-HYDROXYBENZOIC ACID, ETHYL ESTER SODIUM SALT BENZOIC ACID, 4-HYDROXY-, ETHYL P-HYDROXYBENZOATE, ETHYL P-HYDROXYBENZOATE SODIUM SALT, ETHYL PARAHYDROXYBENZOATE, ETHYLPARABEN, ETHYLPARABEN, POTASSIUM SALT, ETHYLPARABEN, SODIUM SALT, POTASSIUM ETHYLPARABEN, POTASSIUM SALT ETHYLPARABEN, SODIUM 4-ETHOXYCARBONYLPHENOXIDE, SODIUM ETHYLPARABEN, SODIUM SALT 4-HYDROXYBENZOIC ACID, ETHYL ESTER, SODIUM SALT BENZOIC ACID, 4-HYDROXY-, ETHYL ESTER, and SODIUM SALT ETHYLPARABEN

What is Ethylparaben used for?

Ethylparaben is a paraben and preservative found in many skin care products, ranging from skin cream to body lotion to deodorant. It can be found in essential oils used to treat dry skin and in primrose oil serving as an anti-septic.

How Ethylparaben is classified

Preservatives

Recommendations for using Ethylparaben during pregnancy and breastfeeding

Avoid

 

Ethylparaben During Pregnancy

What we know about using Ethylparaben while pregnant or breastfeeding

Avoid

1984Methylparaben was nonteratogenic in rabbits, rats, mice and hamsters, and Ethylparaben was nonteratogenic in rats.32008Methylparaben was nonteratogenic in rabbits, rats, mice, and hamsters, and Ethylparaben was nonteratogenic in rats.6 Parabens, even at levels that produce maternal toxicity, do not produce terata in animal studies. One study examined the developmental toxicity of Butylparaben in rats and reported no effect on development up to an oral dose of 1000 mg/kg day- 1, even with some maternal toxicity at that dose. The maternal toxicity NOAEL dose was 100 mg/kg day-1. Parabens have been extensively studied to evaluate male reproductive toxicity. In one in vitro study, sperm viability was eliminated by concentrations as low as 6 mg/ml Methylparaben, 8 mg/ml Ethylparaben, 3 mg/ml Propylparaben, or 1 mg/ml Butylparaben, but an in vivo study of 0.1% or 1.0% Methylparaben or Ethylparaben in the diet of mice reported no spermatotoxic effects. Propylparaben did affect sperm counts at all levels from 0.01% to 1.0%. Epididymis and seminal vesicle weight decreases were reported in rats given a 1% oral Butylparaben dose decreased sperm number and motile activity in F1 offspring of rats maternally exposed to 100 mg/kg day-1 were reported. Decreased sperm numbers and activity were reported in F1 offspring of female rats exposed to Butylparaben at 100 or 200 mg/kg day-1, but there were no abnormalities in the reproductive organs.Methylparaben was studied using [male] rats at levels in the diet up to 10000 ppm (estimated mean dose of 1141.1 mg/kg day- 1) with no adverse effects. Butylparaben was studied using rats at levels in the diet up to 10000 ppm (estimated mean dose of 1087.6 mg/kg day- 1) in a repeat of the study noted above, but using a larger number of animals and a staging analysis of testicular effects. No adverse reproductive effects were found.Butylparaben binds to estrogen receptors in isolated rat uteri, with an affinity orders of magnitude less than natural estradiol. The estrogenic effect of parabens has been estimated by their competitive binding to the human estrogen receptorsŒ± and Œ≤. With DES binding affinity set at 100, the relative binding affinity of the parabens increased as a function of chain length from not detectable for Methylparaben to 0.267 ¬± 0.027 for human estrogen receptor a and 0.340 ¬± 0.031 for human estrogen receptor Œ≤ for Isobutylparaben. In a study of androgen receptor binding, Propylparaben exhibited weak competitive binding, but Methylparaben had no binding effect at all.Parabens and PHBA have been studied in several uterotrophic assays. PHBA at 5 mg/kg day- 1 (s.c.) was reported to produce an estrogenic response in one uterotrophic assay using mice, but there was no response in another study using rats (s.c. up to 5 mg/kg day-1) and mice (s.c. up to 100 mg/kg day-1) and in a study using rats (s.c. up to 100 mg/kg day-1).Methylparaben failed to produce any effect in uterotrophic assays in two laboratories, but did produce an effect in other studies from another laboratory. The potency of Methylparaben was 1000 to 20000 less when compared to natural estradiol. The same pattern was reported for Ethylparaben, Propylparaben, and Butylparaben when potency was compared to natural estradiol; in positive studies the potency of Ethylparaben was 346 to 25000 less; the potency of Propylparaben was 1612 to 20000 less; and the potency of Butylparaben was 436 to 16,666 less. In two studies, Isobutylparaben did produce an estrogenic response in the uterotrophic assay, but the potency was 240,000 to 4,000,000 less than estradiol. In one study, Benzylparaben produced an estrogenic response in the uterotrophic assay, but the potency was 330,000 to 3,300,000 less than estradiol.Estrogenic activity of parabens and PHBA was increased in human breast cancer cells in vitro, but the increases were around 4 orders of magnitude less than that of estradiol. Several overviews of the endocrine disruption (estrogenic and androgenic effects) generally note that any effect of parabens is weak.Another assessment of the endocrine disrupting/estrogenic potential of parabens noted that parabens do not have genotoxic, carcinogenic, or teratogenic potential and are rapidly hydrolyzed to p-hydroxybenzoic acid and excreted. This assessment noted that parabens are able to bind estrogen and androgen receptors, activate estrogen-responsive genes, stimulate cellular proliferation, and increase levels of estrogen receptor protein. To place the in vitro data in context, the assessment cited the comparisons of parabens activity with 17 Œ≤-estradiol and DES (2 to 5 orders of magnitude lower) and phytoestrogens, including isoflavones (comparable or less). This assessment acknowledged increases or decreases in testes, epididymides, or prostate weights in male animals exposed to Butylparaben and Propylparaben and lower sperm counts in rats and mice exposed to Butylparaben and in rats exposed to Propylparaben, but discounted these effects as without pattern or dose-response.Dermal ExposureNo new published dermal DART studies were discovered and no unpublished data were submitted.Distributed for comment only — do not cite or quote Oral ExposureOral DART studies are summarized in Table 12.Statistically-significant, dose-dependent reductions in anogenital distance and ovary weights were observed in offspring of female rats exposed orally to 100 or 500 mg/kg bw/day Butylparaben from gestation day (GD) 7- GD21.59Epididymal sperm counts and the expression of the Sertoli/Leydig cell marker Nr5a1 in adult male offspring were statistically-significantly reduced at 10 mg/kg bw/day or more. Adult prostate weights were statistically significantly reduced at 500 mg/kg bw/day. CYP19 and estrogen receptor (ER)Œ± expression was statistically-significantly increased, and the expression of steroidogenic acute regulatory protein ( StAR), cytochrome cholesterol side-chain cleavage enzyme ( P450scc), estrogen sulfotransferase (SULT1E1), and androgen receptor ( AR) in the testes and methylation rate of the ERŒ± promoterwere statistically-significantly reduced, in male offspring of female rats exposed to 400 or 1000 mg/kg bw/day Butylparaben from GD7 to GD21.60 Weights of the testes, epididymal cauda sperm counts, and daily sperm production i n male offspring were statistically significantly-reduced in the 400 and 1000 mg/kg bw/day groups of rats orally exposed to Butylparaben on GD7 to post-natal day (PND) 21.61 Vimentin filaments showed shorter projections, concentration near the basal region, and disappearance of the apical extensions toward the lumen of the seminiferous tubules in 3-week old rats 6 h after a single 1000 mg/kg bw oral dosage of Butylparaben.62 Spermatogenic cells were detached from Sertoli cells and sloughed into the lumen 24 h after treatment. Prepubertal female rats exposed orally to 1000 mg/kg bw/day Methylparaben or 250 mg/kg bw/day Isopropylparaben on PND21 to PND40 exhibited statistically-significant delays in vaginal opening.63 In the 1000 mg/kg bw/day groups, there were statistically-significant decreases in the weights of the ovaries (Methylparaben orIsopropylparaben) and kidneys (Ethylparaben or Isopropylparaben), and increases in the weights of the adrenal glands (Methylparaben, Ethylparaben, or Propylparaben) and thyroid glands (Methylparaben). Liver weights increased at all dosage rates of Butylparaben. Morphological studies of the uterus revealed myometrial hypertrophy after exposure to 1000 mg/kg bw/day Propylparaben or Isopropylparaben and in animals of all dose groups of Butylparaben and Isobutylparaben. Among the effects on serum hormone concentrations, estradiol concentrations were statistically-significantly reduced (Ethylparaben or Isopropylparaben) and prolactin concentrations were increased (Methylparaben) i n the 1000 mg/kg bw/day groups. Reduced plasma leptin concentrations were observed in male and female offspring of young adult female rats exposed orally to 100 mg/kg bw/day Butylparaben.64F2 pups exhibited statistically-significantly greater mortality at PND 7 and thereafter, compared with controls, in a DART study in which F0 females and their F1 offspring were exposed to 0.105 mg/kg bw/day Methylparaben by gavage.65During lactation, treated ‚Äúparous‚Äù F1 females exhibited mammary alveoli that were not always milk-filled, collapsed alveolar and duct structures with residual secretory content, and marked decrease in the size of the lobular structures.There was no evidence of an effect on the weight of the male reproductive organs, epididymal sperm parameters, hormone concentrations, or histopathology in juvenile male rats exposed via lactation from maternal rats receiving up to 1000 mg/kg bw/day Propylparaben for 8 weeks.66Methylparaben was associated with a statistically-significantly higher incidence of abnormal sperm in rats exposed to 1000-ppm or 10,000-ppm in the diet for 8 weeks, mostly sperm with no head in 4% to 5% of sperm, compared with 2.3% in 100-ppm and control groups.45 Measurements of hormone concentrations were generally not altered, except that testosterone (T) and follicle-stimulating hormone ( FSH) concentrations were higher in the 10,000-ppm Butylparaben-treated group, compared with the control group. The authors concluded that the NOAEC was the highest concentration tested (10,000 ppm), corresponding to a NOAEL of about 1140 and 1100 mg/kg/day for Methylparaben and Butylparaben, respectively.

General safety info about Ethylparaben from CIR

Attached is the re-review of 20 parabens as used in cosmetics. These parabens are reported to function in cosmetics primarily as preservatives. In 2016, Sodium Methylparaben (which had not been reviewed by the Panel) was included in the CIR 2017 Priority List due to the large number of uses reported in the FDA’s VCRP database. The Expert Panel agreed that it would be appropriate to group this ingredient, and some additional parabens and paraben salts, with the previously reviewed ingredients, Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben, for review. Accordingly, this report is a re-review, not a draft report, which the Panel has already agreed to reopen to 1) add the new ingredients, and 2) to assess updates that may have occurred in the safety profiles of the original seven ingredients. [parabe062017Rep]In 2008, a safety assessment of parabens was published with the conclusion that seven parabens were safe in the present practices and concentrations. This report combined parabens that had been reviewed separately in previous reports, which were published in 1984, 1986, and 1995. For the Panel’s convenience, the data from these reports are summarized within the attached report, in italics, in the appropriate sections. The Discussions from these reports are also included in the report. All of these reports are included in this packet for the Panel’s information. [parabe062017Prev_1, 2, 3, 4] The minutes and transcripts of the Panel’s discussions on these reports are also included in this packet. [parabe062017Tran]An exhaustive search was conducted for new data on the safety of parabens; the most relevant data are summarized in this report. A few short-term but no new acute, subchronic or chronic toxicity studies were discovered. Nine new epidemiology studies explored the possibility of associations between markers of paraben exposure and adverse health outcomes, including 3 prospective and 6 retrospective studies. Exposures to Methylparaben, Propylparaben and Butylparaben were evaluated in all of these studies. In addition, exposures to Ethylparaben and Benzylparaben were considered in 6 and 2 of the studies, respectively. Taken together, these studies reported numerous comparisons between exposure markers and outcomes, only a fraction of which were statistically significant. This safety assessment report provides relatively brief __________________________________________________________________________________________1620 L Street, NW Suite 1200, Washington, DC 20036(Main) 202-331-0651 (Fax) 202-331-0088 (Email) cirinfo@cir-safety.org (Website) www.cir-safety.orgsummaries of all of these studies, focused on the statistically-significant results reported, and the details are provided in Table 14.Dermal penetration, toxicokinetics, short-term toxicity, DART, endocrine-activity, and epidemiology studies are also briefly summarized in the body of the report, and details are provided in tables. On the other hand, toxicity studies conducted in animals exposed to individual parabens by subcutaneous injection, and toxicity tests in animals exposed to mixtures of parabens with other compounds (e.g., phthalates), were not included in the current draft of the report. Please note that the objective of some of the most recent animal toxicity studies was to investigate the potential for exposure to parabens at relatively low doses to cause adverse effects.The Council has submitted concentration of use data that have been incorporated into the report.[parabe062017Data1,2] Most of the parabens that were previously in use have increased in the number of uses, and the concentrations of use are similar to those reported previously. No other unpublished data has been submitted.The Panel should review the available data to either affirm or change the conclusion from the 2008 report for the original seven paraben ingredients. The Panel should also determine if this conclusion can be applied to the newly added ingredients, or if a split conclusion is warranted. Whether the conclusion remains the same (and extends to all of the new ingredients) or is to be changed and/or split, the Panel should come to a conclusion of safety and develop the basis for the Discussion. Thereby, the Panel should issue a Tentative Amended Report.However, if information (and/or added ingredients) raise new questions for the Panel that are not answered by the available data, then an Insufficient Data Announcement, with a list of data needs, should be issued.

Use this, not that!

Look for products containing Phenoxyethanol or Sodium Benzoate (and Benzoic Acid), potentially in combination with Potassium Sorbate, instead of parabens

Products where you might find Ethylparaben

N/A