| GHS-Einstufung | This chemical does not meet GHS hazard criteria for 100% (1338 of 1338) of all reports.Not ClassifiedAggregated GHS information provided per 1338 reports by companies from 2 notifications to the ECHA C&L Inventory. |
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| Regulatorische Informationen | Chemical: D-GlucitolRegulation (EC) No 178/2002 (amended)D-Glucitol is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of D-Glucitol 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)D-Glucitol: Does not have an individual approval but may be used under an appropriate group standard |
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| Weitere Sicherheitsinformationen | IMAP assessments - D-Glucitol: Environment tier I assessment |
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| Brandgefahren | Combustible. Finely dispersed particles form explosive mixtures in air. |
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| Brandpotenzial | Combustible |
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| Gesundheitsgefahren | Hot liquid will burn skin. (USCG, 1999) |
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| Gefahrenübersicht | No adverse effects on reproduction, development, or lactation observed in 3-generation study of rats at doses up to 10% of the diet[REPROTOX] May cause gastrointestinal tract effectsHealth effects of exposure to the substance have been investigated extensively but none have been found. [ICSC] May cause irritation[Alfa Aesar MSDS] See Mannitol. |
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| FDA-Anforderungen | Substance added directly to human food affirmed as generally recognized as safe (GRAS).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: sorbitol is included in digestive aid drug products.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: sorbitol is included in oral health care drug products (nonantimicrobial).Sorbitol used as a nutrient and/or dietary supplement in animal drugs, feeds, and related products is generally recognized as safe when used in accordance with good manufacturing or feeding practice.The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl sorbitol, 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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| Reaktive Gruppe | Alcohols and Polyols |
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| Special Reports | IPCS/Commission of the European CommunitiesInternational Chemical Safety Card on D-Sorbitol (October 2002).[Available from, as of January 12, 2009: http://www.inchem.org/pages/icsc.html] |
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| EPA Safer Chemical | Chemical: Sorbitol |
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| FIFRA-Anforderungen | Unless specifically excluded, residues resulting from the use of the following substances as either an inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide chemicals, are exempted from the requirement of a tolerance under FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices. D-Sorbitol is included on this list. |
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| Reactivity Profile | SORBITOL is an alcohol. Flammable and/or toxic gases are generated by the combination of alcohols with alkali metals, nitrides, and strong reducing agents. They react with oxoacids and carboxylic acids to form esters plus water. Oxidizing agents convert them to aldehydes or ketones. Alcohols exhibit both weak acid and weak base behavior. They may initiate the polymerization of isocyanates and epoxides. |
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| Brandbekämpfung | Fire Extinguishing Agents: Water (USCG, 1999)In case of fire in the surroundings, use appropriate extinguishing media. |
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| Erste Hilfe | Only for burns caused by hot liquid. (USCG, 1999) |
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| Brandbekämpfungsverfahren | In case of fire in the surroundings: use appropriate extinguishing media.Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.Special protective equipment for fire-fighters: Wear self contained breathing apparatus for fire fighting if necessary. |
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| Lagerbedingungen | The bulk material is hygroscopic and should be stored in an airtight container in a cool, dry place.Store in cool place. Keep container tightly closed in a dry and well-ventilated place. |
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| Reinigungsverfahren | Personal precautions: Avoid dust formation.Environmental precautions: Do not let product enter drains.Methods for cleaning up: Sweep up and shovel. Keep in suitable, closed containers for disposal. |
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| Entsorgungsverfahren | SRP: 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.Observe all federal, state, and local environmental regulations. |
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| Verschüttetes entsorgen | Sweep spilled substance into covered containers. |
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| Preventive Measures | NO open flames.Prevent deposition of dustclosed system, dust explosion-proof electrical equipment and lighting.Handling: Provide appropriate exhaust ventilation at places where dust is formed. Normal measures for preventive fire protection.In case of skin contact: Wash off with soap and plenty of water.For more Preventive Measures (Complete) data for D-Sorbitol (6 total), please visit the HSDB record page. |
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| Eye Prevention | Wear safety spectacles or eye protection in combination with breathing protection if powder. |
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| Fire Prevention | NO open flames. Closed system, dust explosion-proof electrical equipment and lighting. Prevent deposition of dust. |
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| Inhalation Risk | A nuisance-causing concentration of airborne particles can be reached quickly when dispersed. |
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| Exposure Prevention | PREVENT DISPERSION OF DUST! |
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| Wechselwirkungen | PURPOSE: To examine the effect of common excipients such as sugars (sorbitol versus sucrose) on bioequivalence between pharmaceutical formulations, using ranitidine and metoprolol as model drugs. METHODS: Two single-dose, replicated, crossover studies were first conducted in healthy volunteers (N=20 each) to compare the effect of 5 Gm of sorbitol and sucrose on bioequivalence of 150 mg ranitidine or 50 mg metoprolol in aqueous solution, followed by a single-dose, nonreplicated, crossover study (N=24) to determine the threshold of sorbitol effect on bioequivalence of 150 mg ranitidine in solution. RESULTS: Ranitidine Cmax and AUC0-infinity were decreased by approximately 50% and 45%, respectively, in the presence of sorbitol versus sucrose. Similarly, sorbitol reduced metoprolol Cmax by 23% but had no significant effect on AUC0-infinity. An appreciable subject-by-formulation interaction was found for ranitidine Cmax and AUC0-infinity, as well as metoprolol Cmax. Sorbitol decreased the systemic exposure of ranitidine in a dose-dependent manner and affected bioequivalence at a level of 1.25 Gm or greater. CONCLUSIONS: As exemplified by sorbitol, some common excipients have unexpected effect on bioavailability/bioequivalence, depending on the pharmacokinetic characteristics of the drug, as well as the type and amount of the excipient present in the formulation. More research is warranted to examine other common excipients that may have unintended influence on bioavailability/bioequivalence. |
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| Umweltverhalten | TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 10(SRC), determined from a structure estimation method(2), indicates that D-sorbitol is expected to have very high mobility in soil(SRC). Volatilization of D-sorbitol from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 7.3X10-13 atm-cu m/mole(SRC), using a fragment constant estimation method(3). D-Sorbitol is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 9.9X10-9 mm Hg(SRC), determined from a fragment constant method(4). Utilizing the Japanese MITI test, 81% of the Theoretical BOD was reached in 2 weeks indicating(5) that biodegradation is an important environmental fate process in soil(SRC).AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 10(SRC), determined from a structure estimation method(2), indicates that D-sorbitol 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 7.3X10-13 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). According to a classification scheme(5), an estimated BCF of 3(SRC), from its log Kow of -2.20(6) and a regression-derived equation(7), suggests the potential for bioconcentration in aquatic organisms is low(SRC). D-Sorbitol is not expected to undergo hydrolysis in the environment due to the lack of functional groups that hydrolyze under environmental conditions(3). Utilizing the Japanese MITI test, 81% of the Theoretical BOD was reached in 2 weeks(8) indicating that biodegradation is an important environmental fate process in water(SRC).ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), D-sorbitol, which has an estimated vapor pressure of 9.9X10-9 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 D-sorbitol may be removed from the air by wet or dry deposition(SRC). D-Sorbitol does not contain chromophores that absorb at wavelengths >290 nm(3) and therefore is not expected to be susceptible to direct photolysis by sunlight(SRC). |
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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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| Plant Concentrations | D-Sorbitol occurs naturally in apples, plums, pears, cherries, dates, peaches, apricots and other fruits(1). |
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| Signs and Symptoms | Abdominal cramps. Abdominal pain. Diarrhoea. |
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| Soil Adsorption/Mobility | Using a structure estimation method based on molecular connectivity indices(1), the Koc of D-sorbitol can be estimated to be 10(SRC). According to a classification scheme(2), this estimated Koc value suggests that sorbitol is expected to have very high mobility in soil. |
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| Natural Pollution Sources | Occurs in small amounts in various fruits and berriesD-Sorbitol occurs in apples, plums, pears, cherries, dates, peaches, apricots and other fruits(1).D-Sorbitol, a hexitol, is most widely distributed polyol in nature. It is mainly found in fruits of rosacea. |
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| Human Toxicity Excerpts | /HUMAN EXPOSURE STUDIES/ /ChildChild, preschoolInfant/ Carbohydrate malabsorption after apple juice ingestion may produce abdominal symptoms and diarrhea, especially in children. The carbohydrates suggested to play roles in this process are fructose, as it is present in excess of glucose, and sorbitol. Absorption of the carbohydrates in apple juice was investigated in 17 children and 12 adults by means of the hydrogen breath test. Apple juice was given at a dose of 15 mL/kg body weight, with a maximum of 375 mL. Fructose (0.6 g/kg) and sorbitol (0.06 g/kg), alone and in combination, were administered in amounts similar to their contents in apple juice (fructose as excess over glucose content). Apple juice malabsorption, as judged by a peak breath H2 excretion of > or = 20 ppm, was found in 11 children (65%) and 4 adults (33%). Of those malabsorbing apple juice, 7 of 11 children malabsorbed fructose, 1 of 11 sorbitol, and 4 of 11 the combinationthe four adults absorbed all test solutions completely. ... /No/ additive effect of sorbitol on breath H2 excretion after fructose ingestion /was found/. Peak breath H2 concentrations after apple juice ingestion (mean +/- SEM: 43 +/- 7 ppm) were higher than those with fructose (23 +/- 5 ppmp < 0.05) or the fructose-sorbitol combination (20 +/- 5 ppmp < 0.05). Fructose, and not sorbitol, is the sugar responsible for the increase in breath H2 after apple juice consumption and therefore for the diarrhea accompanying excessive apple juice consumption in toddlers./HUMAN EXPOSURE STUDIES/ The aim of this study was to study sugar maldigestion/malabsorption in patients with functional dyspepsia using H2 breath testing. End-expiratory breath H2 after separate challenges with lactose (25 g), fructose (25 g), and sorbitol (5 g) were used to determine malabsorption, as well as small bowel transit time (SBTT). Five hundred twenty patients with functional dyspepsia received all three challenges. Smaller groups were also tested after lactulose (10 g, N = 36) and glucose (50 g, N = 90) challenges. Fructose and sorbitol were closely linked with respect to absorption and malabsorption status. Only in the case of lactose maldigestion/malabsorption was there a greater than random prevalence of malabsorption (P < 0.001) for fructose and sorbitol. In contrast to lactose, ethnic origin did not influence fructose or sorbitol malabsorption, and females predominated among fructose and sorbitol malabsorbers. In Jews, the prevalence of lactose maldigestion/malabsorption decreased in the age group of 25-55 and subsequently rose after 55, while fructose and sorbitol malabsorption decreased progressively with advancing age. With respect to small bowel transit time (SBTT), in the case of sorbitol and lactulose, it was significantly greater (P < 0.05) than those for fructose and lactose. Multiple sugar malabsorptions are common when lactose maldigestion/malabsorption is present./HUMAN EXPOSURE STUDIES/ Normal subjects may incompletely absorb either lactose, fructose, or sorbitol and may therefore have abdominal symptoms. The frequency of coincidental malabsorption of these sugars is not known. This is clinically important, since we often ingest them during the same day and malabsorption may cause abdominal symptoms. To shed light on this issue ...32 normal subjects /were studied/. Volunteers drank in random order the following solutions: 20 g lactulose, 50 g sucrose, 50 and 25 g lactose, 50 and 25 g fructose, 20 and 10 g sorbitol. Semiquantitative carbohydrate malabsorption was estimated with lactulose standards. Frequency of 50-g lactose (69%), 50-g fructose (81%), and 20-g sorbitol (84%) malabsorption was not significantly different (P = 0.3). The estimated median fraction of the ingested high dose malabsorbed was 42, 19, and 68% for lactose, fructose, and sorbitol, respectively. At low challenging doses, 63% of the volunteers absorbed two of three or all three sugars, and 88% were asymptomatic to two or all three sugars. In conclusion, the frequency of coincidental malabsorption of lactose, fructose, and sorbitol and intolerance to these sugars is not common, when normal adults ingest them at low doses./HUMAN EXPOSURE STUDIES/ The effects of glucose, sorbitol and xylitol ingestion on calciuria, oxaluria and phosphaturia in healthy black and white males on a standardized diet were investigated. After ingestion, they collected urine hourly for 3 hr. Glucose decreased phosphaturia in blacks. Sorbitol decreased phosphaturia in both groups and increased oxaluria in whites. Xylitol increased oxaluria in blacks. Decreases in phosphaturia are attributed to penetration by phosphate into cells leading to decreases in phosphatemia and the renal filtered load. /The authors/ suggest that this mechanism is more sensitive in blacks, ... speculate that the increase in oxaluria after sorbitol ingestion occurs via its conversion to glyoxylate and that this pathway may be blocked in blacks. For the increase in oxaluria after xylitol ingestion, it is hypothesized that ketohexokinase and aldolase may be more active in blacks...For more Human Toxicity Excerpts (Complete) data for D-Sorbitol (9 total), please visit the HSDB record page. |
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| Artificial Pollution Sources | D-Sorbitol's production and use as an excipient in pharmaceutical formulationsas a diluent in tablet formulationsas a stabilizer for drug, vitamin, and antacid suspensions(1)and in the manufacture of sorbose, ascorbic acid, propylene glycol, synthetic plasticizers and resins(2) may result in its release to the environment through various waste streams(SRC). |
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| Environmental Biodegradation | AEROBIC: D-Sorbitol, present at 100 mg/L, reached 81% of its Theoretical BOD in 2 weeks using an activated sludge inoculum at 30 mg/L and the Japanese MITI test(1). |
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| Drug Induced Liver Injury | Drug Induced Liver Injury Rank (DILIrank 2.0)SorbitolvNo-DILI-concernNo matchDOI:10.1016/j.drudis.2016.02.015 |
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| Environmental Bioconcentration | An estimated BCF of 3 was calculated in fish for D-sorbitol(SRC), using a log Kow of -2.20(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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