Propylparaben

The Basics On Propylparaben

What is Propylparaben?

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

What are other names for Propylparaben?

4-HYDROXY- PROPYL ESTER BENZOIC ACID, 4-HYDROXYBENZOIC ACID, PROPYL ESTER, 4-HYDROXYBENZOIC ACID, PROPYL ESTER, SODIUM SALT, BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER, BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER, SODIUM SALT, BENZOIC ACID, 4HYDROXY, PROPYL ESTER, BENZOIC ACID, 4HYDROXY, PROPYL ESTER, SODIUM SALT, POLYPARABEN, POTASSIUM PROPYLPARABEN, POTASSIUM SALT PROPYLPARABEN, PROPYL 4-HYDROXYBENZOATE, PROPYL ESTER 4-HYDROXYBENZOIC ACID, PROPYL ESTER BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER SODIUM SALT 4-HYDROXYBENZOIC ACID, PROPYL ESTER SODIUM SALT BENZOIC ACID, 4-HYDROXY-, PROPYL P-HYDROXYBENZOATE, PROPYL P-HYDROXYBENZOATE SODIUM SALT, PROPYL PARABEN, PROPYL PARAHYDROXYBENZOATE, PROPYLPARABEN, PROPYLPARABEN, POTASSIUM SALT, PROPYLPARABEN, SODIUM SALT, SODIUM 4-PROPOXYCARBONYLPHENOXIDE, SODIUM PROPYLPARABEN, SODIUM SALT 4-HYDROXYBENZOIC ACID, PROPYL ESTER, SODIUM SALT BENZOIC ACID, 4-HYDROXY-, PROPYL ESTER, and SODIUM SALT PROPYLPARABEN

What is Propylparaben used for?

Parabens are a class of chemicals commonly used as preservatives in food, therapeutic and cosmetic products. They are derived from para-hydroxybenzoic acid (PHBA), which occurs naturally in many fruits and vegetables. Parabens come in several forms: methylparaben, Ethylparaben, Propylparaben, Butylparaben, and isobutylparaben. They are the most widely used preservative in personal care products and are used in over 22,000 cosmetics as preservatives at concentrations up to 0.8% (mixtures of parabens) or up to 0.4% (single paraben)1. Their high usage is because they are good at doing their job—keeping your products mold and bacteria free—and they are also cost-effective.

How Propylparaben is classified

Preservatives

Recommendations for using Propylparaben during pregnancy and breastfeeding

Avoid

 

Propylparaben During Pregnancy

What we know about using Propylparaben while pregnant or breastfeeding

Avoid

The European Chemicals Agency classifies a closely related chemical as a substance of very high concern due to endocrine disrupting properties and associated effects on male fertility. European Chemicals Agency (ECHA) 2020. Substance of very high concern (SVHC). The cauda epididymal sperm reserves and concentrations decreased in a dose-dependent manner and the difference was significant at dose of 0.10% and above. Source: Oishi S, 2002 “Effects of propyl paraben on the male reproductive system.” Food Chem Toxicol. 2002 Dec;40(12):1807-13. Methylparaben was nonteratogenic in rabbits, rats, mice and hamsters, and Ethylparaben was nonteratogenic in rats.45 Pregnant animals were given orally 5.0 to 550 mg/kg bw/day (rats, mice) or 3.0 to 300 mg/kg bw/day (hamsters) Methylparaben from Day 6 of gestation to Day 10 (hamsters) or 15 (rats, mice). Pregnant rabbits were orally administered 3.0 to 300 mg/kg bw/day Methylparaben daily from Day 6 of gestation to Day 18. Pregnant rats were dosed in diet of Ethylparaben at concentrations of 0.1, 1, or 10 % between gestation Days 8 and 15. On day 21 of pregnancy, rats were killed, and the number of fetal implantations, status of maternal visceral organs, fetal body weights, and numbers of skeletal, visceral, and external defects in fetuses were recorded. No apparent teratogenesis or toxicity was observed in 363 fetuses from rats fed up to10% Ethylparaben. At the 10% level, cerebral hemorrhages, abnormal enlargement in the ventricles of the brain, and, in some, hydronephrosis and hypo-osteogenesis were observed in fetuses. Some fetuses at 1% Ethylparaben had no blood in the cardiac ventricle; some had intraperitoneal hemorrhages. Fetuses of rats of the 0.1% group had no significant visceral or skeletal defects. 2008 Methylparaben was nonteratogenic in rabbits, rats, mice, and hamsters, and Ethylparaben was nonteratogenic in rats.2 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 bw/day, even with some maternal toxicity at that dose. The maternal toxicity NOAEL dose was 1000 mg/kg bw/day. 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 for 8 weeks reported no spermatotoxic effects. Propylparaben did affect sperm counts at all levels from 0.01% to 1.0% (approximately 10 and 1000 mg/kg bw/day, respectively.). Epididymis and seminal vesicle weight decreases were reported in rats given a 1% oral Butylparaben dose, and decreased sperm number and motile activity in F1 offspring of rats maternally exposed to 100 mg/kg bw/day were reported. Decreased sperm numbers and activity were reported in F1 offspring of female rats exposed to Butylparaben subcutaneously at 100 or 200 mg/kg bw/day, but there were no abnormalities in the reproductive organs. The total treatment period was from gestation day 6 to postnatal day 20, with a 2-day interruption at parturition. Methylparaben was studied using male rats at levels in the diet up to 10,000 ppm (estimated mean dose of 1141.1 mg/kg/day) with no adverse effects. Butylparaben was studied using rats at levels in the diet up to 10,000 ppm (estimated mean dose of 1087.6 mg/kg/day) in a repeat of the study noted above, but using a larger number of animals and a staging analysis of testicular effects. Rats received Butylparaben in the diet for a minimum of 56 days. No adverse reproductive effects were found. Butylparaben, administered subcutaneously at 2mg/kg bw/day in male rats on postnatal days 2 to 18, produced only minor effects on epithelial cell height. No effect of Butylparaben on the expression of the water channel protein aquaphorin-1(APQ1), efferent duct distension, or rete testis morphology was seen. Dermal No new published dermal DART studies were discovered and no unpublished data were submitted. Oral The oral DART studies summarized below are described in Table 13. Time-mated rats were orally exposed to 10, 100, or 500 mg/kg bw/day of Butylparaben from GD 7 to PND 22. 63 The anogenital distance (AGD) of newborn male and female offspring was significantly reduced at 100 or 500 mg/kg bw/day. The reduced expression of the Sertoli/Leydig cell marker Nr5a1 in adult male offspring was statistically significant at 10 mg/kg bw/day or above. In male offspring, epididymal sperm count decreased 76 – 78% compared to controls at all doses from 10 to 500 mg/kg bw/day. The reduction of epididymal sperm count showed the same effect at all doses (i.e. no doseresponse effect was observed). Adult prostate weight reductions were statistically significant at 500 mg/kg bw/day. In prepubertal females, ovary weight reduction was statistically significant and mammary gland outgrowth was increased at 100 and 500 mg/kg bw/day. No clear effect was seen on mammary glands of adult female offspring. Pregnant rats were orally exposed to 64, 160, 400, or 1000 mg/kg bw/day of Butylparaben from GD 7 to PND 21. 64 In the 400 and 1000 mg/kg bw/day groups of male offspring, reduced AGD and delayed preputial separation (PPS) were observed; the weights of the testes were significantly reduced and serum testosterone was reduced in a dose-response manner from PND 21 to PND 90. On PND 90, the number of the caudal epididymal sperm was significantly decreased by approximately 36% at 400 and 1000 mg/kg bw/day, and daily sperm production values were significantly decreased. In contrast, weights of the testes, epididymal cauda sperm counts, serum testosterone (T) and luteinizing hormone (LH) levels, and daily sperm production in male offspring did not change at doses of 64 and 160 mg/kg bw/day. Estradiol (E2) level was significantly elevated in weanling male rats orally exposed to Butylparaben at 50 mg/kg for 8 consecutive weeks, whereas serum levels of the hormones T, LH, and follicle-stimulating hormone (FSH), as well as ratios of T/E2 and T/LH was decreased, compared to control groups.65 Butylparaben treatment elevated markers of testicular DNA damage in a comet assay, such as the increase in the tail DNA%, tail length of DNA, and tail moment. In addition, the testicular malondialdehyde level was significantly elevated, along with a significant decrease in catalase enzyme activity. Histopathological examination showed a reduction in Leydig cells population along with pathological alternations of dilated congested subcapsular blood vessels and the dilation and congestion of interstitial vasculature. The increase of CYP19 and estrogen receptor (ER)Œ± expression; the reduction of steroidogenic acute regulatory protein (StAR), cytochrome cholesterol side-chain cleavage enzyme (P450scc), estrogen sulfotransferase (SULT1E1), and testes androgen receptor (AR) expression; and the reduced methylation rate of the ERŒ± promoter, were statistically significant in male offspring of female rats exposed to 400 or 1000 mg/kg bw/day Butylparaben from GD 7 to GD 21.66 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.67 Spermatogenic cells were detached from Sertoli cells and sloughed into the lumen 24 h after treatment. Prepubertal female rats were exposed orally to Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, or Isobutylparaben in a dose-dependent manner (62.5, 250, and 1000 mg/kg bw/day) on PND 21 to PND 40. Rats treated with 1000 mg/kg bw/day Methylparaben or 250 mg/kg bw/day Isopropylparaben exhibited statisticallysignificant delays in vaginal opening.68 In the 1000 mg/kg bw/day groups, there were statistically-significant decreases in the weights of the ovaries (Methylparaben or Isopropylparaben) 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 statistically significant effects on serum hormone concentrations, estradiol concentrations were reduced (Ethylparaben or Isopropylparaben) and prolactin concentrations were increased (Methylparaben) in 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.69 F2 pups exhibited a statistically-significant 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.70 During 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 gavage receiving up to 1000 mg/kg bw/day Propylparaben for 8 weeks.71 Methylparaben was associated with a statistically-significant 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.49 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 no-observed-adverse-effect-concentration (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. Histopathologic examination revealed progressive detachment and sloughing of spermatogenic cells into the lumen of the seminiferous tubules and reduction and/or disappearance of tubular lumen 3 h after a single 1000 mg/kg oral dosage of Butylparaben in rats. 72 Terminal deoxynucleotidyl transferase (TdT)-mediated fluorescein- dUTP nick end labelling (TUNEL) assays revealed a substantial increase in the number of apoptotic spermatogenic cells in the treated rats; the effect was maximal at 6 h. Subcutaneous Subcutaneous DART studies are also summarized in Table 13. Aquatic Zebrafish embryos were exposed to sub-lethal concentrations of Methylparaben: 0.1, 1, 10, and 100‚ÄØppb. A significant inhibition in the acetylcholinesterase (AChE) activity, as well as an increase in cortisol levels, was observed in the exposed groups.73 Alterations in developmental landmarks such as heart rate and hatching percentage were observed in embryos exposed to 10‚ÄØppb and 100‚ÄØppb of Methylparaben. Anxiety-like behavior was induced in larvae exposed to 0.1‚ÄØppb and 1‚ÄØppb of Methylparaben. Exposure of zebrafish embryos to Methylparaben at 200, 400, 800, and 1000 ŒºM for 96 h post fertilization (hpf), resulted in decreased heart rate and hatching rate and developmental abnormalities, including pericardial edema blood cell accumulation and bent spine.74 The 96 hpf LC50 of Methylparaben was 428 ŒºM (0.065 mg/L) and expression of vitellogenin was significantly upregulated compared to the control group in larval zebrafish exposed to 100 ŒºM (0.015mg/L) of Methylparaben till 96 hpf.

General safety info about Propylparaben from CIR

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of 21 parabens as preservatives in cosmetic products. All of these ingredients are reported to function in cosmetics as preservatives; however, five are reported to also function as fragrance ingredients. The Panel reviewed relevant data relating to the safety of these ingredients under the reported conditions of use in cosmetic formulations. The Panel concluded that 20 of the 21 parabens included in this report are safe in cosmetics in the present practices of use and concentration described in this safety assessment when the sum of the total parabens in any given formulation does not exceed 0.8%. However, the available data are insufficient to support a conclusion of safety for Benzylparaben in cosmetics.

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 Propylparaben

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