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Diss Factsheets
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EC number: 908-700-6 | CAS number: 64519-82-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Investigations of the Metabolic Effects of Acute Doses of Palatinit. Comparison with Fructose and Sucrose in Type II Diabetes.
- Author:
- Bachmann, W., et.al.
- Year:
- 1 984
- Bibliographic source:
- Akt. Ernähr., Vol 6: 65-70
Materials and methods
- Endpoint addressed:
- acute toxicity: oral
- other: metabolic effects
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute doses of 50 g test item were given to 8 metabolically healthy volunteers and compared against 50 g fructose or saccharose to 12 each Type II diabetics. Measurements were conducted over a period of 3 hours in respect of capillary blood glucose, serum insulin, free fatty acids in serum, as well as blood lactate and pyruvate. Clinical signs were observed for 12 hours following treatment.
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol
- EC Number:
- 908-700-6
- Cas Number:
- 64519-82-0
- Molecular formula:
- 6-O-alpha-D-Glucopyranosyl-D-sorbitol: C12H24O11 1-O-alpha-D-Glucopyranosyl-D-mannitol: C12H24O11
- IUPAC Name:
- Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- The study was conducted on 8 metabolically healthy female volunteers plus 24 type II diabetics. Volunteers and patients were accepted for participation in the study on a volunteer basis only after being informed in detail regarding the procedures of the study. All the diabetics were under treatment with oral antidiabetics (sulfonylurea preparations) and diet. In each case the medication was stopped on the evening before the loading test. he metabolically healthy volunteers received the test item loading only once. The 24 patients were subdivided into two groups of 12 each and received either test item and frutose or test item and sucrose as part of two controlled cross-over studies.
The average age of the volunteers in years was 32.7 ± 4.8, and the body weight according to Broca was 85 ± 12%.
Blood samples were taken of capillary blood to determine the blood glucose, and samples of venous blood were taken through a polyethylene cannula inserted into a cubital vein to determine the serum insulin, serum free fatty acids, blood lactate and blood pyruvate levels. Blood samples were taken after fasting as well as 10, 15, 20, 30, 45, 60, 90, 120,150 and 180 minutes after beginning the oral loading. - Exposure assessment:
- not specified
- Details on exposure:
- TYPE OF EXPOSURE: oral
The loading tests were performed with 50 g test item, 50 g fructose or 50 g sucrose in accordance with the standard conditions of an oral glucose tolerance test. The test items were dissolved in 400 mL water and were to be drunk by the test person within 5 minutes.
Results and discussion
- Results:
- In metabolically healthy volunteers, neither blood glucose nor serum insulin or lactate showed any significant change in total level over the observation period of 180 min. The same also applies to the free fatty acids and pyruvate. Only the significant curvature in the blood glucose and insulin curves indicated a certain interim, although minimal, loading. One volunteer complained of meteorism and flatulence within the first 12 h after loading, and another also complained of mild diarrhea.
In the two groups with diabetics there were no increases in blood sugar or serum insulin levels after consuming isomalt, in contrast with observations after sucrose or fructose administration. Gastrointestinal symptoms (meteorism, flatulence, and mild diarrhoea) occurred in 2 - 4 persons in each of the 2 groups.
Applicant's summary and conclusion
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