| GHS-Einstufung | This chemical does not meet GHS hazard criteria for 19.7% (235 of 1192) of reports.WarningH315 (80.2%): Causes skin irritation [Warning Skin corrosion/irritation]P261, P264, P264+P265, P271, P280, P302+P352, P304+P340, P305+P351+P338, P319, P321, P332+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 1192 reports by companies from 31 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies. |
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| Regulatorische Informationen | Chemical: 1,3-Propanediol, 2-amino-2-(hydroxymethyl)-1,3-Propanediol, 2-amino-2-(hydroxymethyl)- is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of 1,3-Propanediol, 2-amino-2-(hydroxymethyl)- 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: 06-04-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/14861.beta.-D-ribo-Hexopyranose, 1,6-anhydro-3-deoxy-2-O-(1-methylethyl)-4-O-(phenylmethyl)-: Does not have an individual approval but may be used under an appropriate group standardTromethamine: Does not have an individual approval but may be used under an appropriate group standard |
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| Weitere Sicherheitsinformationen | IMAP assessments - 1,3-Propanediol, 2-amino-2-(hydroxymethyl)-: Environment tier I assessment |
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| Gefahrenübersicht | Not expected to be a skin sensitizer, based on similar compoundsLittle if any human toxicity observed in many years of use in drugs and/or personal care products and cosmetics[EPA ChAMP: Submission] A skin and strong eye irritant[Alfa Aesar MSDS] |
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| FDA-Anforderungen | The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl tromethamine, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. |
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| DOT Hazard Classification | Tris, bis-bifluoroamino diethoxy propane (TVOPA)Forbidden explosives/materials (49 eCFR § 173.54/§ 173.21) |
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| Hazard Classes and Categories | Skin Irrit. 2 (80.2%) |
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| Lagerbedingungen | Tromethamine injection should be stored at 20-25 °Cfreezing should be avoided. Unused portions of tromethamine solution should be discarded. |
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| Entsorgungsverfahren | SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices. |
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| Protective Action Criteria (PAC) | 18 [mg/m3]190 [mg/m3]1200 [mg/m3] |
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| Umweltverhalten | TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 1(SRC), determined from a structure estimation method(2), indicates that tromethamine is expected to have very high mobility in soil(SRC). However, tromethamine has a pKa of 8.07(3) and should exist partially as a cation under environmental conditions (pH 5-9)(SRC). As a result, tromethamine may have greater adsorption and less mobility than its estimated Koc value indicates since cations generally adsorb more strongly to soils containing organic carbon and clay than neutral species(4). Volatilization of tromethamine from moist soil surfaces is not expected to be an important fate process(SRC) since cations do not volatilize and the estimated Henry's Law constant for the neutral species is 8.7X10-13 atm-cu m/mole(SRC), using a fragment constant estimation method(5). Tromethamine is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 2.2X10-5 mm Hg(SRC), determined from a fragment constant method(6).AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 1(SRC), determined from a structure estimation method(2), indicates that tromethamine is not expected to adsorb to suspended solids and sediment(SRC). However, tromethamine has a pKa of 8.07(3) and should exist partially as a cation under environmental conditions (pH 5-9)(SRC). As a result, tromethamine may have greater adsorption to suspended solids and sediment than its estimated Koc value indicates(SRC). Volatilization from water is not expected(4) since cations do not volatilize and the estimated Henry's Law constant for the neutral species (free base) of tromethamine is 8.7X10-13 atm cu m/mol(SRC), calculated using a fragment constant estimation method(5). According to a classification scheme(6), an estimated BCF of 3(SRC), from an estimated log Kow of -1.56(7) and a regression-derived equation(8), suggests the potential for bioconcentration in aquatic organisms is low(SRC).ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), tromethamine, which has a an estimated vapor pressure of 2.2X10-5 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist in both the vapor and particulate phases in the ambient atmosphere. Vapor-phase tromethamine 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 11 hours(SRC), calculated from its rate constant of 3.4X10-11 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(3). Particulate-phase tromethamine is removed from the atmosphere by wet and dry deposition(SRC). Tromethamine does not contain chromophores that absorb at wavelengths >290 nm and therefore is not expected to be susceptible to direct photolysis by sunlight(4). |
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| Toxizitätsübersicht | Safe in the present practices of use and concentration. Ingredient, concentration, and use information are available in documents discoverable at https://cir-reports.cir-safety.org |
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| Soil Adsorption/Mobility | Using a structure estimation method based on molecular connectivity indices(1), the Koc of tromethamine can be estimated to be 1(SRC). According to a classification scheme(2), this estimated Koc value suggests that tromethamine is expected to have very high mobility in soil(SRC). The pKa of tromethamine is 8.07(3), indicating that this compound will partially exist as a cation in the environment. As a result, the mobility of tromethamine may be overestimated since cations generally adsorb more strongly to soils containing organic carbon and clay than neutral species(4). |
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| Human Toxicity Excerpts | /HUMAN EXPOSURE STUDIES/ In studies of tromethamine administration in healthy individuals, the ventilatory rate remained constant, but a reduced tidal volume produced a decrease in minute ventilation and in carbon dioxide outputarterial oxygen saturation decreased by an average of about 5%./SIGNS AND SYMPTOMS/ Too rapid administration and/or excessive amounts of tromethamine may cause alkalosis, hypoglycemia, overhydration or solute overload. |
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| Artificial Pollution Sources | Tromethamine's production and use as an emulsifying agent, in the synthesis of surface-active agents and vulcanization accelerators(1) may result in its release to the environment through various waste streams(SRC). |
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| Environmental Biodegradation | Tromethamine yielded no oxygen uptake when incubated with pure cultures of different strains of bacteria(1), indicating biodegradation may be slow in the environment. |
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| Carcinogen Classification | Tris(chloropropyl) phosphate (TCPP)Group 2A: Probably carcinogenic to humansVolume 141In prep.2026 |
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| Drug Induced Liver Injury | Drug Induced Liver Injury Rank (DILIrank 2.0)TromethamineAmbiguous-DILI-concern6Adverse reactionsDOI:10.1016/j.drudis.2016.02.015 |
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| Environmental Bioconcentration | An estimated BCF of 3 was calculated for tromethamine (SRC), using an estimated log Kow of -1.56(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC). |
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| Volatilization from Water/Soil | Tromethamine is a weak base with pKa of 8.07(1). This estimated pKa indicates tromethamine will partially exist in the protonated form in the environment. Volatilization from moist soil and water is not expected since cations do not volatilize and the estimated Henry's Law constant for the neutral species (free base) of tromethamine is 8.7X10-13 atm cu m/mol(SRC), using a fragment constant estimation method(2). Tromethamine is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 2.2X10-5 mm Hg(SRC), determined from a fragment constant method(3). |
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| Non-Human Toxicity Excerpts | /LABORATORY ANIMALS: Acute Exposure/ Even after neutralization, large oral doses in lab animals cause weakness, collapse, & coma (without convulsions). Injections of high doses in animals produce hypoglycemia, but concurrent administration of glucose does not prevent death. |
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| Environmental Abiotic Degradation | The rate constant for the vapor-phase reaction of tromethamine with photochemically-produced hydroxyl radicals has been estimated as 3.4X10-11 cu cm/molecule-sec at 25 °C(SRC), using a structure estimation method(1). This corresponds to an atmospheric half-life of about 11 hours(SRC) at an atmospheric concentration of 5X10+5 hydroxyl radicals per cu cm(1). Tromethamine is not expected to undergo hydrolysis in the environment due to the lack of hydrolyzable functional groups(2). Tromethamine does not contain chromophores that absorb at wavelengths >290 nm and therefore is not expected to undergo direct photolysis by sunlight(2). |
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