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Diss Factsheets
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EC number: 946-420-6 | CAS number: -
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar physicochemical, ecotoxicological and toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: the target and source substances are esterification products of fatty acids of varying chain lengths with glycerol and/or polyglycerol.
• the metabolism pathway leads to comparable products (glycerol and/or polyglycerol and medium or long chain fatty acids).
Therefore, read-across from the existing toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see “Justification for read-across” attached to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
see “Justification for read-across” attached to IUCLID section 13
4. DATA MATRIX
see “Justification for read-across” attached to IUCLID section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Radiolabelling:
- yes
- Species:
- rat
- Type:
- metabolism
- Results:
- Hydrolysis of the esters occurred to a large extent prior to absorption.
- Type:
- other: absorption, metabolism
- Results:
- hexa-, penta- and higher polyglycerols are essentially not absorbed and excreted in the faeces unchanged
- Type:
- other: absorption, metabolism
- Results:
- mono-, di- and triglycerols are extensively absorbed from the intestinal tract and rapidly excreted in the urine unchanged
- Type:
- metabolism
- Results:
- fatty acids are metabolized extensively
- Metabolites identified:
- yes
- Details on metabolites:
- free fatty acids + free (poly)glycerol
- Conclusions:
- Based on teh available Metabolic studies it is concluded, that polyglycerin caprylate/caprinate is digested in the gut of the rat to give free polyglycerols and free fatty acids. Lower polyglycerols (up to three glycerol units) are absorbed and excreted unchanged in the urine while higher polyglycerols are excreted in the faeces. Up to 90% of the fatty acid material is absorbed and metabolized.
Reference
Description of key information
Polyglycerin caprylate/caprinate is digested in the gut of the rat to give free polyglycerols and free fatty acids. Lower polyglycerols (up to three glycerol units) are absorbed and excreted unchanged in the urine while higher polyglycerols are excreted in the faeces. Up to 90% of the fatty acid material is absorbed and metabolized.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
No experimental data are available for the target substancepolyglycerin caprylate/caprinate. However, in vivo toxicokinetic data are available for several glycerol, triglycerol and decaglycerol as well as tri- and decaglycerol esters with different numbers (1, 4, and 10) of oleic acid chains. A justification for read-across is given in iuclid section 13.
Data from metabolism studies clearly show that absorption of administered radioactivity was excellent for the fatty acid-labeled polyglycerol (G10) (oleic acid > 90 %; eicosanoic acid > 77%) and triglycerol (G3-oleate) esters. More than 90% of the triglycerol (G3) and - 40 % ofthe polyglycerol (G10) moieties were absorbed. Hydrolysis of the esters occurred to a large extent prior to absorption; the thoracic lymph duct was the major pathway for absorption of the fatty acid moieties, while absorption of the more polar G3 and G10 moieties occurred by some other pathway, presumably the portal vein.
Pancreatic enzymes hydrolyzed the oleate ester linkages of the tri-and polyglycerols as readily as they did those of natural fats (glycerides).
In catabolism studies involving triglycerol (G3*) and polyglycerol (G10*) labeled compounds, less than 4% of the 14C was excreted in the respiratory CO2. This quantity was, within experimental limits of detection, equal to the amount of glycerol contaminant in each sample that was fed. It is concluded that the polyglycerols were not catabolized and that the ether linkages within the molecule are inert to normal enzymatic hydrolysis.
The data also suggested that, unlike glycerol, the polyglycerols (G3* and G10*) were not retained appreciably in the carcass (approx. 5 %). In summary, these results show clearly that the polyglycerols were absorbed and excreted rapidly in the urine without being catabolized.
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.