Sucralose

SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational harm/injury/toxicity or environmental contamination. 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 quality; potential migration in soil or water; effects on animal and plant life; and conformance with environmental and public health regulations.

SRP: In bulk storage or manufacturing situations where combustible dusts can collect in sufficient concentrations to give rise to an explosion/deflagration, reasonable precautions shall be taken to reduce or eliminate the hazard. Efforts shall be made to control or eliminate the five elements necessary to initiate a dust explosion. These include combustible dust (fuel), ignition source (heat), oxygen in air (oxidizer), and dispersion of dust particles in sufficient quantity and concentration as well as confinement of the dust cloud. General guidance in these efforts can be found in OSHA's "Combustible Dust in Industry; Preventing and Mitigating the Effects of Fire and Explosions", which list measures to control dusts, eliminate ignition sources, and limit the effects of explosions.

/The study/...investigated the ability of zinc sulfate (5, 25, 50 mM) to inhibit the sweetness of 12 chemically diverse sweeteners, which were all intensity matched to 300 mM sucrose [800 mM glucose, 475 mM fructose, 3.25 mM aspartame, 3.5 mM saccharin, 12 mM sodium cyclamate, 14 mM acesulfame-K, 1.04 M sorbitol, 0.629 mM sucralose, 0.375 mM neohesperidin dihydrochalcone (NHDC), 1.5 mM stevioside and 0.0163 mM thaumatin]. Zinc sulfate inhibited the sweetness of most compounds in a concentration dependent manner, peaking with 80% inhibition by 50 mM. Curiously, zinc sulfate never inhibited the sweetness of Na-cyclamate. This suggests that Na-cyclamate may access a sweet taste mechanism that is different from the other sweeteners, which were inhibited uniformly (except thaumatin) at every concentration of zinc sulfate.

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 10(SRC), determined from a structure estimation method(2), indicates that sucralose is expected to have very high mobility in soil(SRC). Volatilization of sucralose from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 4.0X10-19 atm-cu m/mole(SRC), using a fragment constant estimation method(3). Sucralose is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 3.2X10-14 mm Hg at 25 °C(SRC), determined from a fragment constant method(4). Mineralization of 14CO2-labeled sucralose ranged from 32.6 to 60.4% over 20 to 101 days using four loam soils(5), indicating that biodegradation may be an important environmental fate process in soil(SRC). However, in an anaerobic environment, sucralose was not mineralized in soil(5).

AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 10(SRC), determined from a structure estimation method(2), indicates that sucralose 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 4.0X10-19 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). According to a classification scheme(5), an estimated BCF of three(SRC), from an estimated log Kow of -1.00(6)and a regression-derived equation(7), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Sucralose is not eliminated in wastewater treatment plants and was shown to be very persistent in surface waters(8), indicating that biodegradation is not 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), sucralose, which has an estimated vapor pressure of 3.2X10-14 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 sucralose may be removed from the air by wet or dry deposition(SRC). Sucralose does not contain chromophores that absorb at wavelengths >290 nm(4), and therefore is not expected to be susceptible to direct photolysis by sunlight(SRC).

/AQUATIC SPECIES/ .../The report presents sucralose/ bioaccumulation studies in the freshwater alga Pseudokirchneriella subcapitata, the crustacean Daphnia magna, and zebrafish (Danio rerio). The freshwater algae and the daphnid tests were performed using a 48-hr static exposure system, whereas the zebrafish test was performed using a 48-hr semi static exposure system followed by 48 hr flow-through of clean water for the depuration phase. All three studies were conducted with two exposure concentrations (10 and 100 mg/L), and the concentrations of sucralose in water and biota were verified by liquid chromatography/mass spectrometry. The studies showed that uptake of sucralose was assumed to achieve a steady state within the first 48 hr, and the bioconcentration factor at the assumed steady state (BCF(SS) ) was calculated to be less than 1 for algae and between 1.6 to 2.2 for the daphnids. The fish BCF(SS), assumed to occur between 24 to 48 hours, were calculated to be less than 1 for both concentrations tested. A first-order one-compartment (uptake phase) and a first-order two-compartment (elimination phase) model characterized the uptake and depuration kinetics in zebrafish (k(1)=0.027-0.038/hr and k(2)=0.206-0.222/hr, t(95)=13.5 to 14.6 hr, t(50)=3.1 to 3.3 hr, and BCF(kinetic)=0.4 to 0.9). .../Therefore,/ sucralose does not bioaccumulate in aquatic organisms from different tiers of the food web, and ... the BCF's obtained were considerably lower than the criteria set to identify persistent, bioaccumulative, and toxic substances (i.e., BCF < 2,000).

Using a structure estimation method based on molecular connectivity indices(1), the Koc of sucralose can be estimated to be 10(SRC). According to a classification scheme(2), this estimated Koc value suggests that sucralose is expected to have very high mobility in soil.

/HUMAN EXPOSURE STUDIES/ A total of .../26/ patients with glycosylated hemoglobin levels < 10% completed ... double-blind cross-over study. After an overnight fast, patients were administered opaque capsules containing either 1,000 mg sucralose or cellulose placebo, followed by a standardized 360-kcal liquid breakfast. Plasma glucose and serum C-peptide levels were measured over the next 4 hr. Regardless of the type of diabetes, areas under the curves for changes of plasma glucose and serum C-peptide levels after sucralose administration were not significantly different from those after placebo. During test meals with sucralose, one episode of symptomatic hypoglycemia occurred in ... three patients, but these episodes were not considered the result of sucralose administration. The present results support the conclusion that sucralose consumption does not adversely affect short-term blood glucose control in patients with diabetes.

/HUMAN EXPOSURE STUDIES/ Eight ... subjects (4 male and 4 female) first received ascending oral doses of TGS in doses of 0.0, 1.0, 2.5, 5.0 and 10.0 mg/kg at 48-hour intervals. This was followed by 7 days continuous administration of 2.0 mg/kg daily for the first three days and 5.0 mg/kg daily for the remaining four days. There were no adverse reactions or complaints throughout the study. No clinically significant changes were observed in temperature, pulse, blood pressure (supine or standing), respiratory rate and general conditions. Detailed hematological and biochemical studies were made before the study, then after 2.0 mg/kg/day and 5.0 mg/kg/day during the second phase. There were no abnormalities in any of the parameters measured. Electrocardiogram studies throughout showed no changes from the initial findings. Urinary examination showed no abnormalities, and an assessment of 24 hour urine volumes throughout the study detected no effects. Blood insulin levels measured one half hour after each dosage showed levels ranging from 4.038.0 milliunits/mL, which were within the fasting range. On Day 25 of the study, blood insulin levels were measured one half hour after 50 g standard sucrose. All showed the characteristic increase within the range 53-108 milliunits/mL.

/CASE REPORTS/ /The study/ report a patient with attacks of migraine consistently triggered by sucralose. She also suffers from menstrually related migraine that had been well-controlled for several months since she switched her contraceptive from fixed estrogen to triphasic contraceptive pills. Some attacks triggered by sucralose were preceded by aura, and she had never experienced migraine with aura before. Withdrawal of the compound was associated with complete resolution of the attacks. Single-blind exposure (vs. sugar) triggered the attacks, after an attack-free period.

AEROBIC: Sucralose is not eliminated in wastewater treatment plants located in the Canton of Zurich, Switzerland and was shown to be very persistent in surface waters. Incubation using activated sludge resulted in no degradation within 7 hours at 15 °C(1).

AEROBIC: Sucralose biodegradation in soil. Acclimation of 4-8 days was observed when using sucrose concentrations at 100 and 1000 mg/kg. Soil characteristics were as follows: Lima loam (pH 7.2; 7.8% organic matter); Kendala loam (pH 7.1; 7.1% organic matter); Erie silt loam (pH 4.9: 5.5% organic matter); Riverhead sandy loam (pH 7.2; 3.6% organic matter)(1). [Table#7886]

AEROBIC: Sucralose mineralization in surface water samples(1). [Table#7887]

AEROBIC: Sucralose mineralization in sediment samples(1).

ANAEROBIC: Sucralose was not mineralized in soil under anaerobic conditions(1).

An estimated BCF of three was calculated in fish for sucralose(SRC), using an estimated log Kow of -1.00(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).

The Henry's Law constant for sucralose is estimated as 4.0X10-19 atm-cu m/mole(SRC) using a fragment constant estimation method(1). This Henry's Law constant indicates that sucralose is expected to be essentially nonvolatile from water and moist soil surfaces(2). Sucralose is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 3.2X10-14 mm Hg(SRC), determined from a fragment constant method(3).

/LABORATORY ANIMALS: Acute Exposure/ Sucralose is a non-nutritive halogenated sucrose derivative that has been described by humans as tasting predominately sweet with little or no aftertaste. ... this study ... examined the preference for sucralose in adult male Sprague Dawley rats. A standard 24 hr two-bottle test was used to compare a wide range of sucralose concentrations (0.0003-10g/L; 0.8 uM-25 mM) with water. The rats did not prefer sucralose to water at low concentrations(0.0003 -0.3 g/L) and avoided sucralose at high concentrations (1-10g/L). Although there are many similarities in the taste preference of humans, mice, and rats, these results suggest that male rats do not prefer sucralose and avoid it at high concentrations.

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Dietary level of trichlorogalactosucrose 0, 10,000, 20,000, 40,000, and 80,000 ppm were fed to the animals /rats/ for 59 days. During this time, the health status, body weight, food and water consumption and urine and feces output were monitored daily with the exception of weeks 7 and 8. Mineral excretion as well as urinary free corticosterone levels were determined on pooled weekly samples from each animal. Mineral intake was calculated weekly and was based on mineral content in the diet and weekly food consumption for each group by sex. Dietary trichlorogalactosucrose had no effects on health status. There appeared to be a trend toward lower body weights in animals fed the higher dietary levels of trichlorogalactosucrose. At 9 weeks, body weights in the females fed 8% trichlorogalactosucrose in the diet were significantly lower than the corresponding controls. Water consumption was significantly increased during week 9 in males fed 2, 4, and 8% trichlorogalactosucrose in the diet. Food consumption was significantly decreased in females fed trichlorogalactosucrose at 1, 4, and 8% during the first week trichlorogalactosucrose was presented in the diet. Fecal output was significantly increased approximately 1.5-fold over control levels in the 4% animals during weeks 3-9 and approximately twofold over control levels in both sexes at the 8% level; and the dry/wet feces ratio was significantly decreased in both males and females during week 3, confirming that the increase in fecal weight was due to an increase in water content. There were no consistent dose-related effects on urine output, caloric efficiency, urinary free corticosterone levels, or the excretion of calcium, magnesium, zinc or copper. A transient decrease in fecal copper was seen in both males and females fed 4 and 8% dietary trichlorogalactosucrose during the second week, and an increase only in males in the ninth week. A not always significant or dose-related trend toward decreased urinary excretion of phosphorous was observed in both males and females throughout the study. Terminal body weights for females fed 4 and 8% trichlorogalactosucrose in the diet were significantly lower than the control terminal body weights. Wet cecum weights with contents were increased significantly in both males and females fed 4 and 8% trichlorogalactosucrose in the diet. No other tissue weights were significantly different from the corresponding controls. However, there was a dose-related trend toward decreased thymus weight in the females. Kidney calcium levels were unaffected as were serum free corticosterone levels and white blood cell counts.

Sucralose is a food additive permitted for direct addition to food for human consumption, as long as 1) the quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food, and 2) any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.

CIR ingredient: Sucralose

Chlorinated derivative of sucrose; Used as a non-nutritive sweetener; [Merck Index]

Flavor enhancer

Add sweetness with or without the extra calories ... /in/ beverages, baked goods, confections, table-top sugar, substitutes, many processed foods

Non-nutritive sweetener

The starting material for the synthesis of sucralose is sucrose. The production route commonly described blocks the three primary hydroxyl groups as trityl ethers, and transforms the secondary hydroxyl groups to acetates to yield 6,1',6'-tritrityl-2,3,4,3',4'- pentaacetylsucrose. By deblocking the primary hydroxyl groups, 2,3,4,3',4'-pentaacetylsucrose is obtained. Under appropriate conditions, this compound can be transformed to 2,3,6,3',4'- pentaacetylsucrose. Chlorination at the exposed hydroxyl groups gives 4,1',6'-trichloro-4,1',6'- tridesoxygalactosucrose on conversion of the glucose moiety to galactose. Removal of the acetate groups by hydrolysis yields sucralose.

Food additives

Food Additives -> SWEETENER -> JECFA Functional Classes

Food Additives -> SWEETENER -> JECFA Functional Classes

Chlorinated sucrose derivative with enhanced sweetness

Compared with dilute sucrose solution, sucralose is about 600 times sweeter. The sweetness is perceived with a slight delay and a lasting effect, similar to aspartame, and generally considered of good quality.

Solid sucralose is not fully stable, and slowly releases HCl, with discoloration. In contrast, aqueous solutions are highly stable, and it is marketed in this form.