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EC number: 700-672-1 | CAS number: 70226-26-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 971
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- Principles of method if other than guideline:
- The catabolism of 14C-labelled polyglycerol ester was tested in rats.
- GLP compliance:
- no
Test material
- Reference substance name:
- Polyglycerol esters
- IUPAC Name:
- Polyglycerol esters
- Details on test material:
- - Name of test material (as cited in study report): 14C-labelled polyglycerol monooleate, polyglycerol monoeicosanoate, polyglycerol decaoleate, polyglycerol monooleate and polyglycerol decaoleate
- Specific activity: 100 µci/g
- Locations of the label: oleic and eicosanoic acid: carbon 1. Either the fatty acid component or the polyglycerol component was labelled.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-250 g
- Housing: animals were placed into metabolism chambers designed for the collection of respiratory CO2, faeces and urine.
- Individual metabolism cages: yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- liquid diet
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- dosing solutions of the 14C-labelled test materials (1%) were prepared by dissolving appropriate amounts in liquid diet containing sucrose, milk, solids, vitamins, salts, water and fat (see Table 1 under "Any other information on materials and methods incl. tables").
VEHICLE
- Concentration in vehicle: 1%
- Amount of vehicle (if gavage): 6-8 g - Duration and frequency of treatment / exposure:
- 51 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1%
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, respiratory CO2, gastrointestinal content and carcass
- Time and frequency of sampling: after administration of the 14C-labelled test substances, animals were immediately placed in individual metabolism chambers for collection of urine, faeces and respiratory CO2.
- Other: Gastrointestinal contents and carcasses were collected after sacrifice and burned to CO2 prior to radioactivity assay (Coots, R. H. (1964). A comparison of the metabolism of elaidic, oleic, palmitic, and stearic acids in the rat. J. Lipid Res. 5, 468-472). - Statistics:
- Mean values and standard errors were calculated.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- polyglycerol monooleate (14C): 95%
- Type:
- absorption
- Results:
- polyglycerol decaoleate (14C): 96%
- Type:
- absorption
- Results:
- polyglycerol monoeicosanoate (14C): 77%
- Type:
- absorption
- Results:
- polyglycerol (14C) monooleate: 44%
- Type:
- absorption
- Results:
- polyglycerol (14C) decaoleate: 40%
- Type:
- distribution
- Results:
- polyglycerol monooleate (14C): 25% in carcass
- Type:
- distribution
- Results:
- polyglycerol decaoleate (14C): 29% in carcass
- Type:
- distribution
- Results:
- polyglycerol monoeicosanoate (14C): 21% in carcass
- Type:
- distribution
- Results:
- polyglycerol (14C) monooleate: 5% in carcass
- Type:
- distribution
- Results:
- polyglycerol (14C) decaoleate: 3% in carcass
- Type:
- excretion
- Results:
- polyglycerol monooleate (14C): (68.5, 2.2, 0.6 and 4% in CO2, urine, faeces and gastrointestinal contents, respectively)
- Type:
- excretion
- Results:
- polyglycerol decaoleate (14C): (66, 1.7, 0.9 and 2.8% in CO2, urine, faeces and gastrointestinal contents, respectively)
- Type:
- excretion
- Results:
- polyglycerol monoeicosanoate (14C): (55.5, 1.6, 9.9 and 12.2% in CO2, urine, faeces and gastrointestinal contents, respectively)
- Type:
- excretion
- Results:
- polyglycerol (14C) monooleate: (2.1, 36.8, 9.5 and 46.5% in CO2, urine, faeces and gastrointestinal contents, respectively)
- Type:
- excretion
- Results:
- polyglycerol (14C) decaoleate: (3.5, 33.5, 15.5 and 44.6% in CO2, urine, faeces and gastrointestinal contents, respectively)
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- A high absorption of administered radioactivity was observed for the fatty acid-labelled polyglycerol esters. The absorption rates were > 95% and 77% for oleic acid- or eicosanoic acid moieties, respectively (see Table 2 under “Any other information on results incl. tables”).
In contrast, based on the recovery of radioactivity from 14C-labelled polyglycerol moieties of the mono- and decaoleate esters, absorption for the polyglycerol moiety was only about 40%. - Details on distribution in tissues:
- A detailed investigation on the distribution of the 14C-labelled polyglycol esters in specific organs and tissues was not performed.
In body carcass, a considerable storage of 14C-labelleled fatty acids from the polyglycerol esters was observed (> 20%). This is in line with the reported storage of long-chain fatty acids in the body fat (Coots, R. H. (1964). A comparison of the metabolism of elaidic, oleic, palmitic, and stearic acids in the rat. J. Lipid Res. 5, 468-472).
The low absorption and high excretion of 14C-labelled polyglycerol moieties corresponded to a poor retention in the body carcass (< 5%) (see Table 2 under “Any other information on results incl. tables”).
- Details on excretion:
- Polymerised glycerols were primarily and rapidly excreted via urine (≥ 40%) and were exreted via faeces to a smaller extent (10-15%). Via the respiratory CO2, less than 4% of the 14C was excreted, whereas ≥ 66% of the radioactivity from labelled oleic acid and ≥ 55% from labelled eicosanoic acid moieties of polyglycerol ester appeared in the respiratory CO2. The excretion of these radiolabelled moieties in urine and faeces was rather low (see Table 2 under “Any other information on results incl. tables”).
Any other information on results incl. tables
Table 2. Disposition of 14C by the rat after administration of 14C-labelled polyglycerol esters.
|
Recovered radioactivity [%] |
||||
14C-labelled compounda |
CO2 |
Urine |
Faeces |
Gastrointestinal contents |
Carcass |
14C-labelled polyglycerol |
|
||||
G10*-O1 |
2.1 ± 0.1 |
36.8 ± 4.6 |
9.5 ± 7.1 |
46.5 ± 11.1 |
5.3 ± 3.5 |
G10*-O10 |
3.5 ± 0.0 |
33.5 ± 1.9 |
15.5 ± 8.7 |
44.6 ± 7.4 |
3.0 ± 0.3 |
14C-labelled fatty acid esters of glycerol |
|
||||
G10-O1* |
68.5 ± 1.6 |
2.2 ± 0.7 |
0.6 ± 0.4 |
4.0 ± 0.8 |
24.7 ± 3.9 |
G10-O10* |
66.0 ± 3.9 |
1.7 ± 0.3 |
0.9 ± 0.3 |
2.8 ± 2.1 |
28.7 ± 3.8 |
G10-E1* |
55.5 ± 4.1 |
1.6 ± 0.3 |
9.9 ± 4.7 |
12.2 ± 4.7 |
20.8 ± 1.7 |
(N = 4 rats per group; mean values ± SEM)
aG10= polyglycerol; O = oleic acid; E = eicosanoic acid; * = 14C-labelled moiety
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.
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