| GHS-Einstufung | DangerH350 (39.1%): May cause cancer [Danger Carcinogenicity]P203, P260, P263, P264, P270, P280, P318, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 138 reports by companies from 17 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.H350: May cause cancer [Danger Carcinogenicity] |
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| Regulatorische Informationen | Hazard Traits - CarcinogenicityStatus: Active Update: 24-08-2021 https://echa.europa.eu/registration-dossier/-/registered-dossier/1910Estra-1,3,5(10)-trien-17-one, 3-hydroxy-: Does not have an individual approval but may be used as a component in a product covered by a group standard. It is not approved for use as a chemical in its own right. |
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| Weitere Sicherheitsinformationen | IMAP assessments - Estra-1,3,5(10)-trien-17-one, 3-hydroxy-: Environment tier I assessment |
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| FDA-Anforderungen | The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, including estrone, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: estrone is included in topical acne drug products. |
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| Special Reports | National Toxicology Program. Eleventh Report on Carcinogens (2005). The Report on Carcinogens is an informational scientific and public health document that identifies and discusses substances (including agents, mixtures, or exposure circumstances) that may pose a carcinogenic hazard to human health. Estrogens, Steroidal are listed as known to be human carcinogens. /Estrogens, Steroidal/[Available from, as of July 31, 2009: http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s084ster.pdf] |
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| Toxic Combustion Products | Emits toxic fumes under fire conditions. |
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| Hazard Classes and Categories | Carc. 1A (39.1%)Carcinogenicity - Category 1A |
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| Brandbekämpfungsverfahren | Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials. ... As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing. |
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| Lagerbedingungen | Store in the original package. Do not store above 25 °C.Store in tight, light-resistant container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity. |
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| Reinigungsverfahren | Wear approved respiratory protection, chemically compatible gloves, and protective clothing. Wipe up spillage or collect spillage using a high-efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill site. |
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| Entsorgungsverfahren | SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.SRP: At the time of review, regulatory criteria for small quantity disposal are subject to significant revision, however, household quantities of waste pharmaceuticals may be managed as follows: Mix with wet cat litter or coffee grounds, double bag in plastic, discard in trash. |
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| Preventive Measures | As a general rule, when handling USP Reference Standards, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.This material is assumed to be combustible. As with all dry powders, it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity.Engineering controls such as exhaust ventilation are recommended.SRP: Wastewater from contaminant suppression, cleaning of protective clothing/equipment, or contaminated sites should be contained and evaluated for subject chemical or decomposition product concentrations. Concentrations shall be lower than applicable environmental discharge or disposal criteria. Alternatively, pretreatment and/or discharge to a permitted wastewater treatment facility is acceptable only after review by the governing authority and assurance that "pass through" violations will not occur. Due consideration shall be given to remediation worker exposure (inhalation, dermal and ingestion) as well as fate during treatment, transfer and disposal. If it is not practicable to manage the chemical in this fashion, it must be evaluated in accordance with EPA 40 CFR Part 261, specifically Subpart B, in order to determine the appropriate local, state and federal requirements for disposal.For more Preventive Measures (Complete) data for ESTRONE (6 total), please visit the HSDB record page. |
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| Personal Protective Equipment (PPE) | Use a NIOSH-approved respirator, if it is determined to be necessary by an industrial hygiene survey involving air monitoring. In the event a respirator is not required, an approved dust mask should be used. Gloves: Chemically compatible. Eye Protection: Safety goggles or glasses. Protective clothing: Protect exposed skin. |
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| Körperbelastung | ... Human colostrum demonstrated a maximum concentration of 4 to 5 ng/mL for estrone. By the 5th day postpartum, it decreased to become similar to cow's milk. |
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| Wechselwirkungen | Within the framework of experiments related to the association between dietary fiber and breast cancer an in vitro test system was used to study the binding of estrogens to various fibers (eg cholestyramin, lignin and cellulose) and fiber sources (eg wheat bran, cereals, seeds and legumes). Furthermore, the in vivo apparent digestibility of the different fiber sources was tested using a mobile nylon bag technique in intestine-cannulate pigs. Estradiol-(17) beta bound more strongly to the various fibers than did estrone, estriol or estrone-3-glucuronide. At increasing pH (greater than 7) binding of both estrone and estradiol-(17) beta to wheat bran decreased significantly. Cholestyramine and lignin bound almost all estrogens present in the medium. Linseed (91%), oats (83%), barley chaff (88%) and wheat bran (82%) are other excellent binders of estradiol-(17) beta. Corn rye and white wheat flour showed lower binding capacity with a relatively low affinity. Cereals with the highest percentage of lignin in the fiber (greater than 3%) were also the fiber sources with the lowest apparent digestibility. Estrogens bound with the highest affinity (relative to bovine serum albumin) to these fiber sources. Together with wheat bran and lignin, oats, linseed and soybean seem to be products with good perspectives for in vivo evaluation of the lowering effect of dietary fiber on estrogen exposure of estrogen sensitive tissues.Estrogens may interfere with the effects of bromocriptinedosage adjustment may be necessary. /Estrogens/Concurrent use with estrogens may increase calcium absorption and exacerbate nephrolithiasis in susceptible individualsthis can be used to therapeutic advantage to increase bone mass. /Estrogens/Concurrent use /of glucocorticoid corticosteroids/ with estrogens may alter the metabolism and protein binding of the glucocorticoids, leading to decreased clearance, increased elimination half-life, and increased therapeutic and toxic effects of the glucocorticoidsglucocorticoid dosage adjustment may be required during and following concurrent use. /Estrogens/For more Interactions (Complete) data for ESTRONE (14 total), please visit the HSDB record page. |
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| Ökotoxizitätswerte | EC50Species: Acartia tonsa (Calanoid Copepod, eggs)Conditions: saltwater, renewalConcentration: 410 ug/L for 5 days (95% confidence interval: 210-810 ug/L)Effect: decreased larval developmentslowed, retarded, delayed or non-development /99% purity/LC50Species: Neomysis integer (Opossum Shrimp, juvenile, length 2-4 mm)Conditions: freshwater, renewal, 15 °CConcentration: >10000 ug/L for 96 hr /100% purity/Species: Tisbe battagliai (Harpacticoid copepod, age <24 hr nauplii)Conditions: saltwater, renewal, 19.4-21.0 °C, pH 7.11-8.42, salinity 34.75-35.55 ppt, dissolved oxygen 7.0-8.4 mg/LConcentration: >100 ug/L for 10 days /formulation/Concentration: >100 ug/L for 21 days /formulation/For more Ecotoxicity Values (Complete) data for ESTRONE (8 total), please visit the HSDB record page. |
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| Umweltverhalten | TERRESTRIAL FATE: Based on a classification scheme(1), a Koc range of 457(2) to 18,000(3), indicates that estrone is expected to have moderate to no mobility in soil(SRC). In soils with a long history of treatment with manure, biosolids, or wastewater, sorption of estrone becomes dependent on soil organic carbon content(4). Volatilization of estrone from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 3.8X10-10 atm-cu m/mole(SRC), using a fragment constant estimation method(5). Estrone is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 2.5X10-10 mm Hg at 25 °C(SRC), determined from a fragment constant method(6). C14-labeled estrone, present at 0.1 mg/kg, reached 2.0-17.4% mineralization in 21 days using natural soils(4,8), indicating that biodegradation may not be an important environmental fate process in soil.AQUATIC FATE: Based on a classification scheme(1), a Koc range of 457(2) to 18,000(3), indicates that estrone is 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 3.8X10-10 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). According to a classification scheme(6), an estimated BCF of 54(SRC), from its log Kow of 3.13(6) and a regression-derived equation(7), suggests the potential for bioconcentration in aquatic organisms is moderate(SRC). Estrone exhibited approximately 38-90% mineralization in 33 days using Colorado river sediments collected downstream from sewage treatment plantsupstream sediments exhibited approximately 1% mineralization(8), respectively, indicating that biodegradation is dependent upon acclimation and may not be an important environmental fate process under pristine conditions(SRC).ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), estrone, which has an estimated vapor pressure of 2.5X10-10 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase estrone may be removed from the air by wet or dry deposition(SRC). Estrone irradiated with a xenon arc lamp exhibited a photodegradation half-life 2-3 hours in river water and 4.7 hours in air-saturated purified water(3), suggesting that estrone is susceptible to direct photolysis by sunlight(SRC). |
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| Expositionspfade | 43% |
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| Milk Concentrations | ENVIRONMENTAL: Free natural estrogens in raw and commercial whole milk were quantitated by radioimmunoassay. The concentration range of estrone was 34 to 55 pg/mL. The proportion of estrone in the fat phases of milk by radioactive tracer on separated milk was 80%. Equilibrium dialysis of skim milk with hydrogen 3-labeled estrogens showed that 84 to 85% of estrone was protein bound. Whey proteins demonstrated a greater binding capacity than casein. This result was confirmed by radioimmunoassay of dry curd cottage cheese and whey. The concentration in curd was 35 pg/g and in whey 4 pg/mL. Butter was highest with a concentration of 539 pg/g. Human colostrum demonstrated a maximum concentration of 4 to 5 ng/mL for estrone. By the 5th day postpartum, it decreased to become similar to cow's milk.EXPERIMENTAL: Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Esterified Estrogens and Methyltestosterone Tablets H.S. and Esterified Estrogens and Methyltestosterone Tablets D.S. are administered to a nursing woman. /Estrone sodium sulfate/... Oestrone sulphate concentration in cow's milk or cream (0.49-0.67 nmol/L)... /Estrone sulphate/ |
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| Toxizitätsübersicht | Estrogens enter the cells of responsive tissues (e.g. female organs, breasts, hypothalamus, pituitary) where they interact with estrogen receptors. Hormone-bound estrogen receptors dimerize, translocate to the nucleus of cells and bind to estrogen response elements (ERE) of genes. Binding to ERE alters the transcription rate of affected genes. Estrogens increase the hepatic synthesis of sex hormone binding globulin (SHBG), thyroid-binding globulin (TBG), and other serum proteins and suppress follicle-stimulating hormone (FSH) release from the anterior pituitary. |
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| Ökotoxizitätsauszüge | /AQUATIC SPECIES/ Estrone is a natural estrogen detected in sewage treatment works effluents and in estuarine waters. However, there is little information on the effects of estrone on marine fish. This study investigated the effects of estrone on reproduction of the estuarine fish, Java medaka (Oryzias javanicus). Java medaka were exposed to concentrations of 39, 198, 484, 1,188, and 3,701 ng/L of estrone from embryonic stages up to adult stages for 239 d after hatching. The fertility and egg numbers of Java medaka exposed to 1,188 and 3,701 ng/L were significantly lower than that of control. The hepatic vitellogenin concentrations in male Java medaka exposed to estrone greater than 484 ng/L were significantly higher than that of control. Oocytes in testis (testis-ova) were not detected in the males in any of the exposure groups. The lowest-observed-effect concentration and no-observed-effect concentration for Java medaka were 484 and 198 ng/L of estrone. These results suggest that in relatively low estrone concentrations, 39 and 198 ng/L, Java medaka will not be affected by exposure to estrone./AQUATIC SPECIES/ Occurrence of alkylphenol ethoxylates or their metabolites (alkylphenols and carboxylated derivatives), as well as natural and synthetic steroids in sewage treatment plant (STP) effluents and in their receiving waters, has been related to biological effects, measured as alterations of plasma vitellogenin (VTG) concentration in natural fish populations. Water composites of STP influents, effluents, sludge, river water, sediment, and feral carps (Cyprinus carpio) were analyzed over a seven-month period in two tributaries of the Llobregat River (NE Spain). ...Natural and synthetic estrogens and progestogens also occurred in the water and sediments analyzed but in the ng/L and ug/kg range, respectively. Vitellogenin fluctuated among sites and sampling periods, but it was found to be increased in male carp collected downstream of the main STP. A correlation between endocrine-disrupting compounds (EDCs) in water and sediment and plasma VTG concentration in male carp was observed, especially for alkylphenolic compounds in water and sediment samples (r = 0.83-0.84 for n = 24) and for estriol and estrone in water (r =0.78 and 0.94 for n = 9 and 8, respectively)./AQUATIC SPECIES/ Animal feeding operations in the United States produce more than 500 million tons of manure annually. Disposal of poultry waste via application as fertilizer results in substantial runoff of poultry litter-associated contaminants (PLAC). Of particular concern are sex steroids, 17beta-estradiol, estrone and testosterone, responsible for sex differentiation and development of reproductive structures. In a series of laboratory assays, mature male and mixed-sex larval/juvenile fish were continuously exposed to environmentally relevant PLAC solutions. Effects on gonads were assessed histologically, and vitellogenin (VTG) induction was measured as a gauge of estrogenicity. Twenty-one-day exposures to laboratory-generated PLAC solutions routinely induced VTG in mature male Pimephales promelas. Vitellogenesis in Fundulus heteroclitus only occurred at the highest tested PLAC concentration, and Cyprinodon variegatus were unresponsive at any tested concentration. All species produced considerable VTG in response to a 17beta-estradiol-positive control. A pronounced feminization was seen in P. promelas when exposed to PLAC as larvae but not when exposed as juveniles. Runoff from a poultry litter-amended field cropped under standard agronomic practices induced significant VTG in male P. promelas. Results indicate that environmentally relevant PLAC concentrations exhibit endocrine activity sufficient to induce VTG production in male fish and possibly affect sex ratios in resident fish populations./AQUATIC SPECIES/ The bioaccumulation of estrone by Daphnia magna was determined. Direct uptake via the aqueous medium occurred within the first 16 hr. A bioconcentration factor of 228 was established over all temporal periods. Ingestion via Chlorella vulgaris gave a partitioning factor of 24, which may approximate to a biomagnification factor assuming steady state conditions. These preliminary results indicate that the partitioning to Daphnia magna via the food source, C. vulgaris is less significant than bioconcentration. |
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| Plant Concentrations | Plants which contain estrone(1). [Table#4532] |
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| Signs and Symptoms | Symptoms of overdose include nausea and vomiting. Estrogen related side effects include nausea, breast tenderness, fluid retention and edema, headaches and/or migraines, chloasma and poor contact lens fit. Estrogen hormone deficiency is associated with breakthrough bleeding, hypomenorrhea, irritability, depression and menopausal symptoms. Withdrawal bleeds may occur in females. |
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| Effluent Concentrations | Estrone was reported in 37% of 95-144 samples of central California municipal waste water treatment plant effluent with a maximum concentration of 19.5 ng/L(1). The compound was tested for but not detected (detection limit = 0.4 ng/L) in effluent samples collected from the Jefferson Parish East Bank Wastewater Treatment Plant in New Orleans, Louisiana between September and November, 2001. It was not detected in effluent samples collected during the same time from the A.H. Weeks Water Treatment Plant and the ENWIN Pilot Plant in Windsor, Ontario, Canada(2). The mean estrone concentration in effluents samples from a large coastal primary sewage treatment plant in Malabar, Sydney, Australia was 54 ng/L(3). Estrone was detected in 15 of 16 effluent samples collected from Ulm, Langenau, and Blaubeuren, southern Germany between June to October 2000 at concentrations ranging from 0.35 to 18 ng/L, median 3.4 ng/L(4). Estrone was detected in 20 of 38 German municipal sewage treatment plant effluents at a median concentration of 0.001 ug/L, maximum 0.070 ug/L(5). Estrone was detected at concentrations of 71.4 (July 2003), 57.8 (Sept 2003), and 17.2 ng/L (Feb 2004) in effluent from the Eysines Sewage Treatment Plant (northern suburbs, Bordeaux, France) and runs through agricultural and residential areas(6). Concentrations in sewage treatment plant effluents were as follows: Italy, 10/99-03/2000, 30 samples, 2.5-92.1 ng/L (9.3 ng/L median)Netherlands, 10/97-12/97, 6 samples, <0.4-47 ng/L (4.5 ng/L median)Germany, 11/97, 16 samples, <detection limit-70 ng/L (9 ng/L median)Canada, 11/97, 10 samples, <detection limit-48 ng/L (3 ng/L median): UK, 5/95-1/96, 21 samples, 1.4-76 ng/L (9.9 ng/L median)Germany, 6/2000-10/2000, 16 samples, <0.1-18 ng/L (1.5 ng/L median)(7).Estrone was detected in a typical dairy waste disposal system for 2000 dairy cows in San Jacinto, CA (ug/kg dry weight) as followsfresh manure less than 2 hrs old, 535piled manure at 2 weeks, 6973 lagoon dams at 3 months at 93, 107, and 68, respectively(2).Land application of animal manures such as poultry litter is a common practice, especially in states with surplus manure. Past studies have shown that animal manure may contain estrogens, which are classified as endocrine-disrupting chemicals and may pose a threat to aquatic and wildlife species. We evaluated the concentrations of estrogens in surface runoff from experimental plots (5 x 12 m each) receiving raw and pelletized poultry litter. We evaluated the free (estrone, E117beta-estradiol, E2betaestriol, E3) and conjugate forms (glucuronides and sulfates) of estrogens, which differ in their toxicity. Sampling was performed for 10 natural storm events over a 4-mo period (April-July 2008). Estrogen concentrations were screened using enzyme-linked immunosorbent assay (ELISA), followed by quantification using liquid chromatography with tandem mass spectrometry (LC/MS/MS). Concentrations of estrogens from ELISA were much higher than the LC/MS/MS values, indicating crossreactivity with organic compounds. Exports of estrogens were much lower from soils amended with pelletized poultry litter than the raw form of the litter. No-tillage management practice also resulted in a lower export of estrogens with surface runoff compared with reduced tillage. The concentrations and exports of conjugate forms of estrogens were much higher than the free forms for some treatments, indicating that the conjugate forms should be considered for a comprehensive assessment of the threat posed by estrogens. |
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| Soil Adsorption/Mobility | The Koc of estrone was reported as 2,000-18,000, using a Chelsea, MI topsoil (total organic carbon 5.45%)(1). Natural estrogens such as estrone are mainly removed from the aqueous phase by adsorption onto solids such as sludge in wastewater or soil in cases of land application(2). Sorption of estrone from CaCl2 solution and artificial urine in pastoral soils from North Island, New Zealand was studied. The log Koc values using Horotiu silt loam (pH 5.4% OC 8.2% Sand 34% Silt 48% Clay 17), Hamilton clay loam (pH 5.1% OC 4% Sand 19% Silt 51% Clay 30), and TeKowhai silt loam (pH 5.1% OC 5% Sand 9% Silt 54% Clay 37) were 2.66 and 2.75, 2.93 and 3.04, and 3.15 and 2.9, respectively(3), corresponding to Koc values of 457 and 562, 851 and 1096, and 1412 and 794, respectively(SRC). According to a classification scheme(4), these Koc values suggest that estrone mobility in soil is moderate to immobile. In soils with a long history of treatment with manure, biosolids, or wastewater, sorption of estrone becomes dependent on soil organic carbon content (SOC). Kd values of 122, 46, 134, 72, and 67 mL/g were reported using Metelan (grassland, SOC 3.3%), Koeln (crop field, 0.7% SOC), Halle (crop field, 1.3% SOC), Gumpenstein (crop field, 2.2% SOC), and Hamapil (orchard, 1.5% SOC) soils in Germany, respectively(5). A Kd of 402 L/kg was reported using activated sludge(6). |
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