Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- Metabolism of Hydrogenated Palatinose, an Equimolar Mixture of α-D-Glucopyranosido-1,6-sorbitol and α-D-Glucopyranosido-1,6-mannitol
- Author:
- Grupp, U. and Siebert, G.
- Year:
- 1 978
- Bibliographic source:
- Res. Exp. Med. (Berl.), 173: 261-278
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female rats of 180 g were adapted to 34.5% test item in the diet during 24 days. On the day of the experiment, 5 g food containing 1.7 g test item were fed to the fasted animals, and 20 animals sacrified 0.5-1 h after start of feeding, 20 animals 2-3 h later, 5 animals after 4.5 h and 9 animals after 6 h. The contents of stomach, small intestine, caecum and large intestine were collected under methanol, and the combined samples of each time period and anatomical location analysed by gas chromatography.
- 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
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: SIV-50
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas, Kisslegg, Germany
- Weight at study initiation: 180 g
- Housing: individually in wire cages
- Diet: Altromin (Altrogge, Lage, Geramny), offered in limited amounts
- Water: tap water from bottles, ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): not specified
- Experimental diets were based on casein-starch as follows: 20% casein, 0.24% vitamin mixture, 4% salt mixture, 5% hydrogenated vegetable oil, 2% cellulose, 69% corn starch. Additions of test item, GPS or GPM respectivcly were made by exchanging 50% of starch or saccharose with the corresponding disaccharidc alcohols, giving 34.5% of each component. At the start of feeding experiments, however, the initial diet contained only 10% of the disaccharide alcohols, which was raised to 20%, 30% and finally 34.5% within a few days each, in order to avoid diarrhoea. - Duration and frequency of treatment / exposure:
- Following 24 days of adaption to increasing amounts of test item in the diet, animals were fasted and subsequently dosed once with 1.7 g/animal in 5 g of diet
Doses / concentrations
- Dose / conc.:
- 1.7 other: g/animal
- Remarks:
- in 5 g synthetic diet
- No. of animals per sex per dose / concentration:
- 5 to 20 animals per sampling time point
- Control animals:
- no
- Details on dosing and sampling:
- METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: intestinal contents (stomach, small intestine, caecum, large intestine)
- Time and frequency of sampling: 0.5-1 h after start of feeding (20 animals), 2-3 h after feeding (20 animals), 4.5 h after feeding (5 animals), 6 h after feeding (9 animals)
- From how many animals: see above, pooled samples were analysed
- Method type for identification: gas chromatography
- Limits of detection and quantification: not specified - Statistics:
- All statistical calculations were done with Student's t-test.
Results and discussion
- Preliminary studies:
- not specified
Main ADME results
- Type:
- metabolism
- Results:
- Ingested test item partially arrived unsplit in the caecum and underwent fermentation there; excretions in faeces and urine are neglegible in the rat.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Remarks:
- α -D-glucopyranosido-1,6-sorbitol , α-D-glucopyranosido-1,6-mannitol, sorbitol and mannitol
- Details on metabolites:
- The time course of the fate of test item in the digestive tract is depicted in Table 1. While the stomach is being emptied after a standard dose of 1.7 g in 5 g synthetic diet, progressively more disaccharide alcohols and hexitols are found in small intestine, caecum, and to some extent also in large intestine, as time proceeds. lt follows from these data, that uncleaved disaccharide alcohols appear beyond the small intestine and must have escaped digestion by carbohydrases in the upper part of the digestive tract. α -D-glucopyranosido-1,6-sorbitol (GPS) and α-D-glucopyranosido-1,6-mannitol (GPM) are found in small intestine at 5-14% of the amount in the stomach. Three to six hours after the test meal, per animal 80-105 mg of disaccharide alcohols plus hexitols are found beyond the small intestine. Whereas these compounds may exist in even Iarger amounts in the caecum than in small intestine at intermediate times, a sharp decrease is observed between caecum and large intestine: after, e.g., 4.5 h, 4.8 to 8.3 times higher amounts of all four compounds are recovered from the caecum than from the Iarge intestine. Obviously, the caecum is functioning like a sink for disaccharide alcohols as well as hexitols which points to this part of the gut as the site where substances which have escaped digestion and/or absorption in small intestine, are cleaved and eventually fermented.
Actually, caeca were enlarged, both in tissue and in total. weights, and their content is always a grayish mass with many small gas bubbles, indicating fermentation. From the data of Table 2 it can be concluded that disaccharide alcohols as well as hexitols disappear while passing through the caecum, thus cleavage of glycoside bonds as well as bacterial fermentation obviously proceeds in this organ.
A small portion of disaccharide alcohols is excreted in stool and feces respectively. Data for rat faeces demonstrate that after a few days the test item is excreted just at the level of analytical detectability. In experiments with healthy human volunteers, only neglegible amounts of test item are found in the stool. Accordingly, the test item undergoes practically complete degradation in man and rat during passage through the digestive tract. Whatever amount may have escaped caecal fermentation (see data for large intestine in Table 1) becomes obviously finally degraded in the colon or rectum.
Any other information on results incl. tables
Table 1. Disaccharide alcohols and hexitols in the intestinal tract of rats (mg/animal)
Time period after feeding (h) |
|
|
GPS |
GPM |
Sorbitol |
Mannitol |
0.5 -1 |
|
stomach |
205 |
260 |
6 |
5 |
|
|
small intestine |
20 |
35 |
22 |
15 |
|
|
caecum |
5 |
5 |
8 |
9 |
|
|
large intestine |
0 |
0 |
0 |
0 |
2 - 3 |
|
stomach |
155 |
170 |
7 |
6 |
|
|
small intestine |
23 |
45 |
25 |
1.5 |
|
|
caecum |
5 |
35 |
42 |
40 |
|
|
large intestine |
0 |
5 |
6 |
3 |
4.5 |
|
stomach |
80 |
100 |
6 |
3 |
|
|
small intestine |
25 |
50 |
22 |
12 |
|
|
caecum |
24 |
65 |
27 |
25 |
|
|
large intestine |
5 |
10 |
5 |
3 |
6 |
|
stomach |
25 |
30 |
3 |
2 |
|
|
small intestine |
20 |
30 |
12 |
10 |
|
|
caecum |
18 |
70 |
21 |
15 |
|
|
large intestine |
5 |
12 |
3 |
2 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.