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Home > Products >  China Largest Manufacturer factory sales Sodium Cyclamate CAS 139-05-9

China Largest Manufacturer factory sales Sodium Cyclamate CAS 139-05-9 CAS NO.139-05-9

  • FOB Price: USD: 1.00-2.00 /Kilogram Get Latest Price
  • Min.Order: 500 Kilogram
  • Payment Terms: L/C,D/A,D/P,T/T,Other
  • Available Specifications:

    AAAAA(50-100)KilogramAAAAA(100-500)Kilogram

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Keywords

  • Sodium Cyclamate
  • Sodium Cyclamate
  • 139-05-9

Quick Details

  • ProName: China Largest Manufacturer factory sal...
  • CasNo: 139-05-9
  • Molecular Formula: 139-05-9
  • Appearance: white powder
  • Application: Pharm chemicals industry
  • DeliveryTime: 3-5 days
  • PackAge: 25KG/Drum
  • Port: Shanghai Guangzhou Qingdao Shenzhen
  • ProductionCapacity: 20 Metric Ton/Month
  • Purity: 99%
  • Storage: 2-8°C
  • Transportation: By air /Sea/ coruier
  • LimitNum: 500 Kilogram
  • Heavy metal: 10PPM
  • Color: red
  • Melting point: ≥350°C
  • Boiling point: 363.24°C (rough estimate)
  • density: 1.667
  • solubility: 1 M NaOH: 10 mg/mL, dark green
  • Water Solubility: <0.1 g/100 mL at 21 oC
  • Stability: Stable. Combustible. Incompatible with...

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Sodium N-cyclohexylsulfamate Basic information
Product Name: Sodium N-cyclohexylsulfamate
Synonyms: assurgrinfeinsuss;assurgrinvollsuss;asugryn;cyclamate,sodiumsalt;cyclamic;cyclohexanesulfamicacid,monosodiumsalt;cyclohexanesulphamicacid,monosodiumsalt;cyclohexyl-sulfamicacimonosodiumsalt
CAS: 139-05-9
MF: C6H12NNaO3S
MW: 201.22
EINECS: 205-348-9
Product Categories: Food & Feed ADDITIVES;Food additive, Sweeteners;Building Blocks;Chemical Synthesis;Organic Building Blocks;Sulfonic/Sulfinic Acid Salts;Sulfur Compounds
Mol File: 139-05-9.mol
Sodium N-cyclohexylsulfamate Structure
 
Sodium N-cyclohexylsulfamate Chemical Properties
Melting point  >300 °C (lit.)
storage temp.  room temp
solubility  200g/l
form  Powder
color  White
PH 5.5-7.5 (100g/l, H2O, 20℃)
Water Solubility  >=10 g/100 mL at 20 ºC
Merck  14,2703
BRN  4166868
InChIKey UDIPTWFVPPPURJ-UHFFFAOYSA-M
CAS DataBase Reference 139-05-9(CAS DataBase Reference)
IARC 3 (Vol. Sup 7, 73) 1999
EPA Substance Registry System Sodium cyclamate (139-05-9)
 
Safety Information
Hazard Codes  Xn
Risk Statements  22
Safety Statements  36/37-24/25
WGK Germany  3
RTECS  GV7350000
TSCA  Yes
HS Code  29299000
Toxicity Sodium cyclamate is a non-nutritive sweetener that is about 30 times sweeter than cane sugar. The oral LD50s in rats and mice are 15.25 and 17.0 g/kg, respectively. It was banned as a food additive because of findings that it caused bladder cancer in rodents. It appears to act as a promoter. There is also evidence that it causes toxicity in the male reproductive system.
MSDS Information
Provider Language
Sodium N-cyclohexylsulfamate English
SigmaAldrich English
ALFA English
 
Sodium N-cyclohexylsulfamate Usage And Synthesis
Chemical Properties White powder
Chemical Properties Sodium cyclamate occurs as white, odorless or almost odorless crystals, or as a crystalline powder with an intensely sweet taste.
History Cyclamate was first synthesized in 1937. Like the other sweeteners, its sweet taste was accidentally discovered (U.S. Pat. 2,275,125 (Mar. 3, 1942), L. F. Andrieth and M. Sveda (to E. I. du Pont de Nemours & Co., Inc.). The FDA in 1958 classified sodium cyclamate as a GRAS sweetener. In 1969, a 2-year chronic toxicity study with a sodium cyclamate–sodium saccharin (10:1) mixture found bladder tumors in rats. The FDA took cyclamate off the GRAS list, banning it from foods and beverages, but permitting its sale in pharmacies. In 1970, after a congressional investigation, the FDA banned the use of cyclamate entirely. Abbott Laboratories, which has conducted additional toxicity and carcinogenicity studies with cyclamate, a 10:1 mixture of cyclamate–saccharin, and cyclohexylamine, claimed to be unable to confirm the 1969 findings. Abbott then filed a food additive petition for cyclamate in 1973, which was denied by the FDA in 1980. In 1982, the Calorie Control Council and Abbott Laboratories filed a second food additive petition containing the results of additional safety studies (The Calorie Control Council and Abbott Laboratories, Food Additive Petition for cyclamate 2A3672 (Sept. 22, 1982). That petition remains active.
Uses Sodium Cyclamate is an artificial sweetener and is 30 times as saccharose's. It is widely used in pickles, seasoning sauce, cakes, biscuits, bread, ice cream, frozen sucker, popsicles, drinks and so on, with a maximum amount of 0.65g/kg. Secondly, it is used in confect, with a maximum amount of 1.0g/kg. Thirdly, it is used in orange peel, preserved plum, dried arbutus and so on, with the largest amount of 8.0g/kg. It is also used in cosmetics and pharmaceutical industry.
Uses Cyclamate (cyclohexylsulfamic acid and its calcium and sodium salts) were discovered in the United States in 1937. They are 30 to 80 times as sweet as sucrose and were widely used until late 1969, when it was banned by the FDA because of questions on safety. It is not banned in Canada and the European Union.
Cyclamate is produced by reacting cyclohexylamine with sulfonating agents, followed by reactions with sodium or calcium hydroxides to produce cyclamates and free cyclohexylamine as follows.
Owing to their good stability, cyclamates are suitable for all applications of intense sweeteners without a significant interfering taste sensation, and are heat stable. The main application of cyclamates is in blends with saccharin in a 10:1 ratio by weight. The mixture is more than twice as sweet as either component alone, making them an important sweetener in countries approving the use of both sweeteners.
Uses Sweetening agent.
Production Methods Cyclamates are prepared by the sulfonation of cyclohexylamine in the presence of a base. Commercially, the sulfonation can involve sulfamic acid, a sulfate salt, or sulfur trioxide. Tertiary bases such as triethylamine or trimethylamine may be used as the condensing agent. The amine salts of cyclamate that are produced are converted to the sodium, calcium, potassium, or magnesium salt by treatment with the appropriate metal oxide.
Brand name Adocyl;Ampenoline balsamoco;Assugrin;Azucrona;Cyclarin;Glusac super;Ilgon;Sladicin;Sucaryl calcium;Sucaryl sodium;Sucrum 7.
World Health Organization (WHO) Cyclamates, non-nutritive sweetening agents, have been used as additives in food and drugs since 1950. They have been demonstrated to have a carcinogenic potential at very high and long-sustained dosage in experimental animals. Some countries have consequently banned their use as food additives, whereas in others they remain available for this purpose. Most countries, however, continue to allow their use in small quantities in pharmaceutical preparations. (Reference: (WHODI) WHO Drug Information, 77.2, 12, 1977)
General Description Odorless or almost odorless white crystals or crystalline powder. Intensely sweet taste, even in dilute solution. pH (10% solution in water): 5.5-7.5. Used as a non-nutritive sweetener.
Air & Water Reactions Water soluble.
Reactivity Profile Sodium N-cyclohexylsulfamate is incompatible with strong oxidizing agents, strong acids and strong bases. Also incompatible with nitrites in acid solution. Has only limited compatibility with potassium salts .
Hazard Some evidence of causing cancer in lab- oratory animals. Prohibited by FDA for food use. Questionable carcinogen.
Fire Hazard Flash point data for Sodium N-cyclohexylsulfamate are not available; however, Sodium N-cyclohexylsulfamate is probably combustible.
Pharmaceutical Applications Sodium cyclamate is used as an intense sweetening agent in pharmaceutical formulations, foods, beverages, and table-top sweeteners. In dilute solution, up to about 0.17% w/v, the sweetening power is approximately 30 times that of sucrose. However, at higher concentrations this is reduced and at a concentration of 0.5% w/v a bitter taste becomes noticeable. Sodium cyclamate enhances flavor systems and can be used to mask some unpleasant taste characteristics. In most applications, sodium cyclamate is used in combination with saccharin, often in a ratio of 10 : 1.
Biochem/physiol Actions Phenylsulfamate sweet tastant detectable by humans. ′First generation′ sweetener studied in animal models for its carcinogenic potential.
Toxicology Sodium cyclamate is an odorless powder. It is about 30 times as sweet as sucrose in dilute solution. The structure of sodium cyclamate is shown in Figure 10.10 Capillary transitional cell tumors were found in the urinary bladders of 8 out of 80 rats that received 2600 mg/kg body weight per day of a mixture of sodium cyclamate and sodium saccharin (10:1) for up to 105 weeks. When the test mixture was fed at dietary levels designed to furnish 500, 1120, and 2500 mg/ kg body weight to groups of 35 and 45 female rats, the only significant finding was the occurrence of papillar carcinomas in the bladders of 12 of 70 rats fed the maximum dietary level of the mixture (equivalent of about 25 g/kg body weight) for periods ranging from 78 to 105 weeks (except for one earlier death). In vivo conversion from sodium cyclamate to cyclohexylamine was observed particularly in the higher dosage group. Cyclohexylamine is very toxic (LD50 rat oral=157 mg/dg) compared to sodium cyclamate (LD50 oral=12g/kg).
Safety Profile Moderately toxic by intravenous and intraperitoneal routes. Mildly toxic by ingestion. Experimental reproductive effects. Questionable carcinogen with experimental neoplastigenic, tumorigenic, and teratogenic data. Human mutation data reported. When heated to decomposition it emits very toxic fumes of NazO, SOx, and NOx.
Safety There has been considerable controversy concerning the safety of cyclamate following the FDA decision in 1970 to ban its use in the USA. This decision resulted from a feeding study in rats that suggested that cyclamate could cause an unusual form of bladder cancer. However, that study has been criticized because it involved very high doses of cyclamate administered with saccharin, which has itself been the subject of controversy concerning its safety; see Saccharin. Although excreted almost entirely unchanged in the urine, a potentially harmful metabolite of sodium cyclamate, cyclohexylamine, has been detected in humans. In addition, there is evidence to suggest cyclamate is metabolized to cyclohexylamine by the microflora in the large intestine of some individuals (approximately 25% of the population with higher precedence in Japanese than Europeans or North Americans). Cyclohexylamine, following absorption, is metabolized to an extent of 1-2% to cyclohexanol and cyclohexane-1,2-diol. Established no-observedeffect level (NOEL) and acceptable daily intake (ADI) values are based on cyclohexylamine levels of high cyclamate converters.(6,7) Extensive long-term animal feeding studies and epidemiological studies in humans have failed to show any evidence that cyclamate is carcinogenic or mutagenic. As a result, sodium cyclamate is now accepted in many countries for use in foods and pharmaceutical formulations.
Few adverse reactions to cyclamate have been reported, although its use has been associated with instances of photosensitive dermatitis.
The WHO has set an estimated acceptable daily intake for sodium and calcium cyclamate, expressed as cyclamic acid, at up to 11 mg/kg body-weight. In Europe, a temporary acceptable daily intake for sodium and calcium cyclamate, expressed as cyclamic acid, has been set at up to 1.5 mg/kg body-weight.
LD50 (mouse, IP): 1.15 g/kg
LD50 (mouse, IV): 4.8 g/kg
LD50 (mouse, oral): 17 g/kg
LD50 (rat, IP): 1.35 g/kg
LD50 (rat, IV): 3.5 g/kg
LD50 (rat, oral): 15.25 g/kg
storage Sodium cyclamate is hydrolyzed by sulfuric acid and cyclohexylamine at a very slow rate that is proportional to the hydrogen ion concentration. Therefore, for all practical considerations, it can be regarded as stable. Solutions are also stable to heat, light, and air over a wide pH range.
Samples of tablets containing sodium cyclamate and saccharin have shown no loss in sweetening power following storage for up to 20 years.
The bulk material should be stored in a well-closed container in a cool, dry place.
Regulatory Status The use of cyclamates as artificial sweetners in food, soft drinks, and artificial sweetening tablets was at one time prohibited in the UK and some other countries owing to concern about the metabolite cyclohexylamine. However, this is no longer the case, and cyclamates are now permitted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (oral powder, solutions, chewable tablets, and suspensions). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
 
Sodium N-cyclohexylsulfamate Preparation Products And Raw materials
Raw materials Trimethylamine-->PETROLEUM ETHER-->Sulfamic acid-->Sulfur trioxide-->Cyclohexylamine-->Tetrachloroethylene-->Cyclamic acid-->Sulfamic acid monosodium salt-->SULPHUR TRIOXIDE-TRIMETHYLAMINE COMPLEX, 95



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Leader Biochemical Group is a large leader incorporated industry manufacturers and suppliers of advanced refined raw materials From the year of 1996 when our factory was put into production to year of 2020, our group has successively invested in more than 52 factories with shares and subordinates.We focus on manufacture Pharm & chemicals, functional active ingredients, nutritional Ingredients, health care products, cosmetics, pharmaceutical and refined feed, oil, natural plant ingredients industries to provide top quality of GMP standards products.All the invested factories' product lines cover API and intermediates, vitamins, amino acids, plant extracts, daily chemical products, cosmetics raw materials, nutrition and health care products, food additives, feed additives, essential oil products, fine chemical products and agricultural chemical raw materials And flavors and fragrances. Especially in the field of vitamins, amino acids, pharmaceutical raw materials and cosmetic raw materials, we have more than 20 years of production and sales experience. All products meet the requirements of high international export standards and have been recognized by customers all over the world. Our manufacture basement & R&D center located in National Aerospace Economic & Technical Development Zone Xi`an Shaanxi China. Now not only relying on self-cultivation and development as well as maintains good cooperative relations with many famous research institutes and universities in China. Now, we have closely cooperation with Shanghai Institute of Organic Chemistry of Chinese Academy of Science, Beijing Institute of Material Medical of Chinese Academy of Medical Science, China Pharmaceutical University, Zhejiang University. Closely cooperation with them not only integrating Science and technology resources, but also increasing the R&D speed and improving our R&D power. Offering Powerful Tech supporting Platform for group development. Keep serve the manufacture and the market as the R&D central task, focus on the technical research.  Now there are 3 technology R & D platforms including biological extract, microorganism fermentation and chemical synthesis, and can independently research and develop kinds of difficult APIs and pharmaceutical intermediates. With the strong support of China State Institute of Pharmaceutical Industry (hereinafter short for CSIPI), earlier known as Shanghai Institute of Pharmaceutical Industry (SIPI), we have unique advantages in the R & D and industrialization of high-grade, precision and advanced products.  Now our Group technical force is abundant, existing staff more that 1000 people, senior professional and technical staff accounted for more than 50% of the total number of employees, including 15 PhD research and development personnel, 5 master′ S degree in technical and management personnel 9 people. We have advanced equipment like fermentation equipment and technology also extraction, isolation, purification, synthesis with rich production experience and strict quality control system, According to the GMP required, quickly transforming the R&D results to industrial production in time, it is our advantages and our products are exported to North and South America, Europe, Middle East, Africa, and other five continents and scale the forefront in the nation, won good international reputation.  We believe only good quality can bring good cooperation, quality is our key spirit during our production, we are warmly welcome clients and partner from all over the world contact us for everlasting cooperation, Leader will be your strong, sincere and reliable partner in China.

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Sodium N-cyclohexylsulfamate Basic information
Product Name: Sodium N-cyclohexylsulfamate
Synonyms: assurgrinfeinsuss;assurgrinvollsuss;asugryn;cyclamate,sodiumsalt;cyclamic;cyclohexanesulfamicacid,monosodiumsalt;cyclohexanesulphamicacid,monosodiumsalt;cyclohexyl-sulfamicacimonosodiumsalt
CAS: 139-05-9
MF: C6H12NNaO3S
MW: 201.22
EINECS: 205-348-9
Product Categories: Food & Feed ADDITIVES;Food additive, Sweeteners;Building Blocks;Chemical Synthesis;Organic Building Blocks;Sulfonic/Sulfinic Acid Salts;Sulfur Compounds
Mol File: 139-05-9.mol
Sodium N-cyclohexylsulfamate Structure
 
Sodium N-cyclohexylsulfamate Chemical Properties
Melting point  >300 °C (lit.)
storage temp.  room temp
solubility  200g/l
form  Powder
color  White
PH 5.5-7.5 (100g/l, H2O, 20℃)
Water Solubility  >=10 g/100 mL at 20 ºC
Merck  14,2703
BRN  4166868
InChIKey UDIPTWFVPPPURJ-UHFFFAOYSA-M
CAS DataBase Reference 139-05-9(CAS DataBase Reference)
IARC 3 (Vol. Sup 7, 73) 1999
EPA Substance Registry System Sodium cyclamate (139-05-9)
 
Safety Information
Hazard Codes  Xn
Risk Statements  22
Safety Statements  36/37-24/25
WGK Germany  3
RTECS  GV7350000
TSCA  Yes
HS Code  29299000
Toxicity Sodium cyclamate is a non-nutritive sweetener that is about 30 times sweeter than cane sugar. The oral LD50s in rats and mice are 15.25 and 17.0 g/kg, respectively. It was banned as a food additive because of findings that it caused bladder cancer in rodents. It appears to act as a promoter. There is also evidence that it causes toxicity in the male reproductive system.
MSDS Information
Provider Language
Sodium N-cyclohexylsulfamate English
SigmaAldrich English
ALFA English
 
Sodium N-cyclohexylsulfamate Usage And Synthesis
Chemical Properties White powder
Chemical Properties Sodium cyclamate occurs as white, odorless or almost odorless crystals, or as a crystalline powder with an intensely sweet taste.
History Cyclamate was first synthesized in 1937. Like the other sweeteners, its sweet taste was accidentally discovered (U.S. Pat. 2,275,125 (Mar. 3, 1942), L. F. Andrieth and M. Sveda (to E. I. du Pont de Nemours & Co., Inc.). The FDA in 1958 classified sodium cyclamate as a GRAS sweetener. In 1969, a 2-year chronic toxicity study with a sodium cyclamate–sodium saccharin (10:1) mixture found bladder tumors in rats. The FDA took cyclamate off the GRAS list, banning it from foods and beverages, but permitting its sale in pharmacies. In 1970, after a congressional investigation, the FDA banned the use of cyclamate entirely. Abbott Laboratories, which has conducted additional toxicity and carcinogenicity studies with cyclamate, a 10:1 mixture of cyclamate–saccharin, and cyclohexylamine, claimed to be unable to confirm the 1969 findings. Abbott then filed a food additive petition for cyclamate in 1973, which was denied by the FDA in 1980. In 1982, the Calorie Control Council and Abbott Laboratories filed a second food additive petition containing the results of additional safety studies (The Calorie Control Council and Abbott Laboratories, Food Additive Petition for cyclamate 2A3672 (Sept. 22, 1982). That petition remains active.
Uses Sodium Cyclamate is an artificial sweetener and is 30 times as saccharose's. It is widely used in pickles, seasoning sauce, cakes, biscuits, bread, ice cream, frozen sucker, popsicles, drinks and so on, with a maximum amount of 0.65g/kg. Secondly, it is used in confect, with a maximum amount of 1.0g/kg. Thirdly, it is used in orange peel, preserved plum, dried arbutus and so on, with the largest amount of 8.0g/kg. It is also used in cosmetics and pharmaceutical industry.
Uses Cyclamate (cyclohexylsulfamic acid and its calcium and sodium salts) were discovered in the United States in 1937. They are 30 to 80 times as sweet as sucrose and were widely used until late 1969, when it was banned by the FDA because of questions on safety. It is not banned in Canada and the European Union.
Cyclamate is produced by reacting cyclohexylamine with sulfonating agents, followed by reactions with sodium or calcium hydroxides to produce cyclamates and free cyclohexylamine as follows.
Owing to their good stability, cyclamates are suitable for all applications of intense sweeteners without a significant interfering taste sensation, and are heat stable. The main application of cyclamates is in blends with saccharin in a 10:1 ratio by weight. The mixture is more than twice as sweet as either component alone, making them an important sweetener in countries approving the use of both sweeteners.
Uses Sweetening agent.
Production Methods Cyclamates are prepared by the sulfonation of cyclohexylamine in the presence of a base. Commercially, the sulfonation can involve sulfamic acid, a sulfate salt, or sulfur trioxide. Tertiary bases such as triethylamine or trimethylamine may be used as the condensing agent. The amine salts of cyclamate that are produced are converted to the sodium, calcium, potassium, or magnesium salt by treatment with the appropriate metal oxide.
Brand name Adocyl;Ampenoline balsamoco;Assugrin;Azucrona;Cyclarin;Glusac super;Ilgon;Sladicin;Sucaryl calcium;Sucaryl sodium;Sucrum 7.
World Health Organization (WHO) Cyclamates, non-nutritive sweetening agents, have been used as additives in food and drugs since 1950. They have been demonstrated to have a carcinogenic potential at very high and long-sustained dosage in experimental animals. Some countries have consequently banned their use as food additives, whereas in others they remain available for this purpose. Most countries, however, continue to allow their use in small quantities in pharmaceutical preparations. (Reference: (WHODI) WHO Drug Information, 77.2, 12, 1977)
General Description Odorless or almost odorless white crystals or crystalline powder. Intensely sweet taste, even in dilute solution. pH (10% solution in water): 5.5-7.5. Used as a non-nutritive sweetener.
Air & Water Reactions Water soluble.
Reactivity Profile Sodium N-cyclohexylsulfamate is incompatible with strong oxidizing agents, strong acids and strong bases. Also incompatible with nitrites in acid solution. Has only limited compatibility with potassium salts .
Hazard Some evidence of causing cancer in lab- oratory animals. Prohibited by FDA for food use. Questionable carcinogen.
Fire Hazard Flash point data for Sodium N-cyclohexylsulfamate are not available; however, Sodium N-cyclohexylsulfamate is probably combustible.
Pharmaceutical Applications Sodium cyclamate is used as an intense sweetening agent in pharmaceutical formulations, foods, beverages, and table-top sweeteners. In dilute solution, up to about 0.17% w/v, the sweetening power is approximately 30 times that of sucrose. However, at higher concentrations this is reduced and at a concentration of 0.5% w/v a bitter taste becomes noticeable. Sodium cyclamate enhances flavor systems and can be used to mask some unpleasant taste characteristics. In most applications, sodium cyclamate is used in combination with saccharin, often in a ratio of 10 : 1.
Biochem/physiol Actions Phenylsulfamate sweet tastant detectable by humans. ′First generation′ sweetener studied in animal models for its carcinogenic potential.
Toxicology Sodium cyclamate is an odorless powder. It is about 30 times as sweet as sucrose in dilute solution. The structure of sodium cyclamate is shown in Figure 10.10 Capillary transitional cell tumors were found in the urinary bladders of 8 out of 80 rats that received 2600 mg/kg body weight per day of a mixture of sodium cyclamate and sodium saccharin (10:1) for up to 105 weeks. When the test mixture was fed at dietary levels designed to furnish 500, 1120, and 2500 mg/ kg body weight to groups of 35 and 45 female rats, the only significant finding was the occurrence of papillar carcinomas in the bladders of 12 of 70 rats fed the maximum dietary level of the mixture (equivalent of about 25 g/kg body weight) for periods ranging from 78 to 105 weeks (except for one earlier death). In vivo conversion from sodium cyclamate to cyclohexylamine was observed particularly in the higher dosage group. Cyclohexylamine is very toxic (LD50 rat oral=157 mg/dg) compared to sodium cyclamate (LD50 oral=12g/kg).
Safety Profile Moderately toxic by intravenous and intraperitoneal routes. Mildly toxic by ingestion. Experimental reproductive effects. Questionable carcinogen with experimental neoplastigenic, tumorigenic, and teratogenic data. Human mutation data reported. When heated to decomposition it emits very toxic fumes of NazO, SOx, and NOx.
Safety There has been considerable controversy concerning the safety of cyclamate following the FDA decision in 1970 to ban its use in the USA. This decision resulted from a feeding study in rats that suggested that cyclamate could cause an unusual form of bladder cancer. However, that study has been criticized because it involved very high doses of cyclamate administered with saccharin, which has itself been the subject of controversy concerning its safety; see Saccharin. Although excreted almost entirely unchanged in the urine, a potentially harmful metabolite of sodium cyclamate, cyclohexylamine, has been detected in humans. In addition, there is evidence to suggest cyclamate is metabolized to cyclohexylamine by the microflora in the large intestine of some individuals (approximately 25% of the population with higher precedence in Japanese than Europeans or North Americans). Cyclohexylamine, following absorption, is metabolized to an extent of 1-2% to cyclohexanol and cyclohexane-1,2-diol. Established no-observedeffect level (NOEL) and acceptable daily intake (ADI) values are based on cyclohexylamine levels of high cyclamate converters.(6,7) Extensive long-term animal feeding studies and epidemiological studies in humans have failed to show any evidence that cyclamate is carcinogenic or mutagenic. As a result, sodium cyclamate is now accepted in many countries for use in foods and pharmaceutical formulations.
Few adverse reactions to cyclamate have been reported, although its use has been associated with instances of photosensitive dermatitis.
The WHO has set an estimated acceptable daily intake for sodium and calcium cyclamate, expressed as cyclamic acid, at up to 11 mg/kg body-weight. In Europe, a temporary acceptable daily intake for sodium and calcium cyclamate, expressed as cyclamic acid, has been set at up to 1.5 mg/kg body-weight.
LD50 (mouse, IP): 1.15 g/kg
LD50 (mouse, IV): 4.8 g/kg
LD50 (mouse, oral): 17 g/kg
LD50 (rat, IP): 1.35 g/kg
LD50 (rat, IV): 3.5 g/kg
LD50 (rat, oral): 15.25 g/kg
storage Sodium cyclamate is hydrolyzed by sulfuric acid and cyclohexylamine at a very slow rate that is proportional to the hydrogen ion concentration. Therefore, for all practical considerations, it can be regarded as stable. Solutions are also stable to heat, light, and air over a wide pH range.
Samples of tablets containing sodium cyclamate and saccharin have shown no loss in sweetening power following storage for up to 20 years.
The bulk material should be stored in a well-closed container in a cool, dry place.
Regulatory Status The use of cyclamates as artificial sweetners in food, soft drinks, and artificial sweetening tablets was at one time prohibited in the UK and some other countries owing to concern about the metabolite cyclohexylamine. However, this is no longer the case, and cyclamates are now permitted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (oral powder, solutions, chewable tablets, and suspensions). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
 
Sodium N-cyclohexylsulfamate Preparation Products And Raw materials
Raw materials Trimethylamine-->PETROLEUM ETHER-->Sulfamic acid-->Sulfur trioxide-->Cyclohexylamine-->Tetrachloroethylene-->Cyclamic acid-->Sulfamic acid monosodium salt-->SULPHUR TRIOXIDE-TRIMETHYLAMINE COMPLEX, 95

 

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