| GHS-Einstufung | This chemical does not meet GHS hazard criteria for 60.7% (811 of 1336) of all reports.DangerH304 (33.5%): May be fatal if swallowed and enters airways [Danger Aspiration hazard]P261, P264, P264+P265, P272, P280, P301+P316, P302+P352, P305+P351+P338, P321, P331, P332+P317, P333+P317, P337+P317, P362+P364, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 1336 reports by companies from 10 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.This chemical does not meet GHS hazard criteria for 100% (2 of 2) of all reports. |
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| Regulatorische Informationen | Chemical: Benzoic acid, 4-hydroxy-, ethyl esterHazard Traits - Endocrine ToxicityReproductive ToxicityCommission Regulation (EC) No 1565/2000 (Repealed by Com. Implementing Reg. (EU) No 872/2012)Benzoic acid, 4-hydroxy-, ethyl ester is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Benzoic acid, 4-hydroxy-, ethyl ester are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)Status: Active Update: 31-01-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/13843Status: Active Update: 08-11-2018 https://echa.europa.eu/registration-dossier/-/registered-dossier/15930 |
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| Weitere Sicherheitsinformationen | IMAP assessments - Parabens: Human health tier II assessment |
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| Gefahrenübersicht | Parabens are an uncommon cause of allergic contact dermatitis[Marks, p. 115] A mild skin irritant with some evidence of skin sensitization in human studiesCaused mild eye irritation, no to minimal skin irritation, and no skin sensitization in animal studies[HSDB] An eye and mild skin irritantMay cause skin sensitization[eChemPortal: ERMA] Parabens can induce allergic contact dermatitis, mainly in chronic dermatitis and wounded skin. [Kanerva, p. 1822-3] May cause irritation[MSDSonline] |
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| FDA-Anforderungen | Ethyl p-hydroxybenzoate is an indirect food additive for use only as a component of adhesives. |
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| Special Reports | Cosmetic Ingredient ReviewFinal Amended Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in Cosmetic Products. Int J Toxicol 27 Suppl 4: 1-82 (2008)[Available from, as of November 21, 2016: http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/PR427.pdf] |
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| Toxic Combustion Products | Special hazards arising from the substance or mixture: Carbon oxides |
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| Hazard Classes and Categories | Asp. Tox. 1 (33.5%)Not Classified |
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| Skin, Eye, and Respiratory Irritations | ... when tested using Human Patch tests (undiluted material) only a limited number of people developed mild skin irritation. |
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| Hazardous Reactivities and Incompatibilities | Incompatible materials: Strong oxidizing agents, strong bases |
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| Brandbekämpfungsverfahren | Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.Advice for firefighters: Wear self contained breathing apparatus for fire fighting if necessary. |
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| Lagerbedingungen | Keep container tightly closed in a dry and well-ventilated place. |
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| Reinigungsverfahren | ACCIDENTAL RELEASE MEASURES: Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Avoid breathing dust. Environmental precautions: Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided. Methods and materials for containment and cleaning up: Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal. |
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| Entsorgungsverfahren | SRP: Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air qualitypotential migration in air, soil or watereffects on animal, aquatic and plant lifeand conformance with environmental and public health regulations. If it is possible or reasonable use an alternative chemical product with less inherent propensity for occupational harm/injury/toxicity or environmental contamination.Product: Offer surplus and non-recyclable solutions to a licensed disposal companyContaminated packaging: Dispose of as unused product. |
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| Preventive Measures | ACCIDENTAL RELEASE MEASURES: Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Avoid breathing dust. Environmental precautions: Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided.Precautions for safe handling: Avoid formation of dust and aerosols. Further processing of solid materials may result in the formation of combustible dusts. The potential for combustible dust formation should be taken into consideration before additional processing occurs.Appropriate engineering controls: Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.SRP: The scientific literature for the use of contact lenses by industrial workers is inconsistent. The benefits or detrimental effects of wearing contact lenses depend not only upon the substance, but also on factors including the form of the substance, characteristics and duration of the exposure, the uses of other eye protection equipment, and the hygiene of the lenses. However, there may be individual substances whose irritating or corrosive properties are such that the wearing of contact lenses would be harmful to the eye. In those specific cases, contact lenses should not be worn. In any event, the usual eye protection equipment should be worn even when contact lenses are in place. |
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| Protective Action Criteria (PAC) | 31 [mg/m3]340 [mg/m3]2100 [mg/m3] |
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| Personal Protective Equipment (PPE) | Eye/face protection: Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).Skin protection: Handle with gloves.Body Protection: Choose body protection in relation to its type, to the concentration and amount of dangerous substances, and to the specific work-place.Respiratory protection Respiratory protection is not required. Where protection from nuisance levels of dusts are desired, use type N95 (US) or type P1 (EN 143) dust masks. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). |
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| Körperbelastung | Ethylparaben concentrations below the quantitation limit (0.02 ng/mL) to 2.69 ng/mL and 0.11-31.7 ng/mL in urine samples from children from the United States and China, respectively. Levels in adults were below the quantitation limit to 47.5 ng/mL and below the quantitation limit to 119 ng/mL, respectively(1). Ethylparaben had a frequency of detection of 58% in urine samples from a group of US male and female adults sampled from 2003 to 2005(2). |
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| Wechselwirkungen | The biological fates of ethyl paraben after the simultaneous administration with salicylic acid were different from those of ethyl paraben alone as reported in the previous reports. The excretion of unconjugated p-hydroxybenzoic acid, which is a hydrolyzed product of ethyl paraben, increased and those of p-hydroxyhippuric acid, glycine conjugate of p-hydroxybenzoic acid, and p-hydroxybenzoyl glucuronide, its ester type glucuronide, decreased. The blood concentration patterns were considerably different from those of ethyl paraben alone, especially the elimination of every metabolite was delayed. Pharmacokinetic analyses on the data of blood concentration were carried out and the results also show the interaction of salicylic acid on the biological fate of ethyl paraben. |
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| Ökotoxizitätswerte | EC50Species: Pseudokirchneriella subcapitata (Green Algae) exponential growth phaseConditions: freshwater, staticConcentration: 18000 ug/L for 72 hr (95% confidence interval: 17000-19000 ug/L)Effect: population, decreased population growth rate /formulation/LC50Species: Dugesia japonica (Flatworm) body length 0.7 cmConditions: freshwater, static, 25 °CConcentration: 39000 ug/L for 24 hr (95% confidence interval: 36900-40600 ug/L) />99% purity/Concentration: 31000 ug/L for 96 hr (95% confidence interval: 30000-31900 ug/L) />99% purity/ |
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| Umweltverhalten | TERRESTRIAL FATE: Based on a classification scheme(1), Koc values ranging from 119 to 209(2) indicate that ethylparaben is expected to have high to moderate mobility in soil(SRC). The pKa of ethylparaben is 8.34(3), indicating that this compound will partially exist in the anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). Volatilization of ethylparaben from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 4.8X10-9 atm-cu m/mole(SRC), using a fragment constant estimation method(5). Ethylparaben is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 9.3X10-5 mm Hg(SRC), determined from a fragment constant method(6). Half-lives of about 14 days and 3.5 days were measured in aerobic screening tests conducted with phenol- and cresol-acclimated sludge over 7 day and 1 day incubation periods(7,8), respectively, suggesting that biodegradation may be an important fate process in soil(SRC).AQUATIC FATE: Based on a classification scheme(1), Koc values ranging from 119 to 209(2), indicate that ethylparaben is not expected to adsorb to suspended solids and sediment(SRC). Volatilization from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 4.8X10-9 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). According to a classification scheme(5), an estimated BCF of 20(SRC), from its log Kow of 2.47(6) and a regression-derived equation(7), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Half-lives of about 14 days and 3.5 days were measured in aerobic screening tests conducted with phenol- and cresol-acclimated sludge over 7 day and 1 day incubation periods(8,9), respectively, suggesting that biodegradation may be an important fate process in water(SRC).ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), ethylparaben, which has an estimated vapor pressure of 9.3X10-5 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), will exist in both the vapor and particulate phases in the ambient atmosphere. Vapor-phase ethylparaben is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals(SRC)the half-life for this reaction in air is estimated to be one day(SRC), calculated from its rate constant of 1.3X10-11 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(3). Particulate-phase ethylparaben may be removed from the air by wet and dry deposition(SRC). Ethylparaben contains chromophores that absorb at wavelengths >290 nm(4) and therefore may be susceptible to direct photolysis by sunlight(SRC). |
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| Lebensmitteluntersuchungswerte | Occurrence of ethylparaben in food samples collected from several grocery stores in Albany, NY in 2008, 2011 and 2012(1).[Table#2493] |
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| Unerwünschte Wirkungen | Skin Sensitizer - An agent that can induce an allergic reaction in the skin. |
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| Toxizitätsübersicht | The CIR Expert Panel concluded that the following 20 parabens are safe in cosmetics in the present practices of use and concentration described in the safety assessment when the sum of the combined concentration of parabens in any given formulation does not exceed 0.8 %...Ehtylparaben..Safe for use in cosmetics, with qualificationsIDENTIFICATION AND USE: Ethylparaben forms small colorless crystals, or white powder. Ethylparaben inhibits the growth of fungi and bacteria and is used as a preservative for pharmaceuticals, adhesives, and various cosmetic preparations. HUMAN EXPOSURE AND TOXICITY: Ethylparaben was a skin irritant in man. It gave no evidence of sensitizing potential in a human study. The paraben esters as a generic class are rare sensitizers when applied to the intact skin of man. Application to the damaged skin is a more common cause of sensitization. A methyl:ethyl:propylparaben mixture has been shown on oral administration to exacerbate pre-existing skin complaints. ANIMAL STUDIES: Ethylparaben was an eye irritant in rabbits. A low acute oral toxicity has been demonstrated for ethylparaben in laboratory animals. Limited long-term studies in rats have also indicated a low toxicity and have generated no evidence of carcinogenic activity. Ethylparaben in the diet produced cell proliferation in the forestomach of rats. No evidence of mutagenicity was reported in limited Ames Bacterial tests. Ethylparaben did increase chromosomal aberrations in a Chinese Hamster ovary cell assay, but similar effects were not seen in rats treated with ethylparaben. Fetal toxicity at maternally toxic dose levels occurred in female rats treated orally during pregnancy. Ethylparaben was nonteratogenic in rats. In one in vitro study, sperm were not viabile at concentrations as low as 8 mg/mL for Ethylparaben, but an in vivo study of 0.1% or 1.0% for Ethylparaben in the diet of mice reported no spermatotoxic effects. |
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| Average Daily Intake | Estimated daily intakes of ethylparaben from indoor dust (13 cities, 4 countries) from the United States, China, Korea and Japan (all ng/kg bw/day)(1).[Table#2492] |
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| Ökotoxizitätsauszüge | /AQUATIC SPECIES/ The acute toxicity of 21 parabens and their chlorinated derivatives was investigated by means of two toxicity bioassays: Daphnia magna immobilization test and the inhibition of bioluminescence of Vibrio fischeri. The median effective concentration (EC(50)) values of the tested parabens ranged from 2.2 to 62 mg/L in the D. magna test and from 0.0038 to 5.9 mg/L in the V. fischeri test at 15 min after exposure. The toxicity of dichlorinated methyl- and n-propylparaben, the most commonly used preservatives in cosmetics, toward D. magna was 3.9- and 2.8-fold that of their corresponding parent compounds. Toxicity toward D. magna showed a linear relationship with log P, indicating that toxicity increases with increasing hydrophobicity. On the other hand, the correlations of toxicity toward V. fischeri with hydrophobicity and with the degree of chlorination were poor. In addition, the results of the present study indicated that the V. fischeri test was more sensitive than the D. magna test for the determination of the acute toxicity of parabens. A complete assessment of the ecological and toxicological risks of parabens may require the examination of chlorinated parabens as well as the parent pollutants, as described in the present study./AQUATIC SPECIES/ The chronic toxicity of 12 compounds of parabens and their chlorinated by-products was investigated using 7-day Ceriodaphnia dubia test under static renewal condition in order to generate information on how to disinfect by-products of preservatives that are discharged in aquatic systems. The mortality and inhibition of reproduction tended to increase with increasing hydrophobicity and decreased with the degree of chlorination of parabens. The EC50 values for mortality, offspring number, and first brood production ranged between 0.30-3.1, 0.047-12, and 1.3-6.3 mg/L, respectively. For the number of neonates, the most sensitive endpoint, the no-observed-effect concentration (NOEC) and lowest-observed-effect concentration (LOEC) values ranged from 0.63 to 10 mg/L and from 1.2 to 19 mg/L, respectively. Methylparaben (MP), benzylparaben (BnP), and dichlorinated BnP (Cl2BnP) elicited a significant decrease in offspring numbers even at their lowest concentration testedthe NOEC for these compounds was determined to be less than the lowest test concentration (1.3, 0.04, and 0.63 mg/L for MP, BnP, and Cl2BnP, respectively). Propylparaben (PP), chlorinated PP, isopropylparaben (iPP), and chlorinated iPP exhibited nonmonotonic concentration-dependent responsetheir NOEC and LOEC values could not be determined. The multivariate approach involving principal component analysis and hierarchical cluster analysis revealed four groups that corresponded to the toxicological profiles of parabens. Our results suggested that disinfection of parabens by chlorination could reduce aquatic toxicity of original compounds. The findings obtained in our study together with the data available on paraben concentrations in aquatic systems can be used to perform preliminary risk assessment by comparing the predicted environmental concentration (PEC) with the predicted no-effect concentration (PNEC) for the marine aquatic environment. The calculated PEC/PNEC ratios ranged from 0.0012 to 0.2, with the highest value observed in MP. This suggested that there are negligible environmental risks for aquatic organisms at current use levels. |
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| Ongoing Test Status | EPA has released the Interactive Chemical Safety for Sustainability (iCSS) Dashboard. The iCSS Dashboard provides an interactive tool to explore rapid, automated (or in vitro high-throughput) chemical screening data generated by the Toxicity Forecaster (ToxCast) project and the federal Toxicity Testing in the 21st century (Tox21) collaboration. /The title compound was tested by ToxCast and/or Tox21 assays/[USEPAICSS Dashboard ApplicationAvailable from, as of September 8, 2016: http://actor.epa.gov/dashboard/] |
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| Effluent Concentrations | The average concentration of ethylparaben in 21 influent and effluent samples from wastewater treatment plants on the Turia River, Valencia, Spain were 72 ng/L (21 samples positive) and not detected (21 samples positive), respectively. Sampling was conducted in October, 2012limit of quantitation effluent = 1.5(1). The compound was detected at a range of 589-2002, 4-50 and 1-13 ng/L in influent, final effluent and surface waters, respectively, in the UK(2). |
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| Soil Adsorption/Mobility | Koc values of 209, 162 and 119 have been reported for acidic forest soil, agricultural soil and sediment samples obtained from Lake Constance, Germany, respectively(1). Based on a recommended classification scheme(2), these Koc values indicate that ethylparaben is expected to have high to moderate mobility in soil. The pKa of ethylparaben is 8.34(3), indicating that this compound will partially exist in anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). |
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