Registration Dossier
Registration Dossier
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EC number: 293-026-9 | CAS number: 91050-80-5
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:
- supporting study
- 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:
- other: absorption in thoracic duct lymph... (see attached file)
- Principles of method if other than guideline:
- Simultaneous catabolism-absorption study on polyglycerol esters in thoracic duct-cannulated 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): polyglycerol monooleate (14C), polyglycerol monoeicosanoate (14C), polyglycerol decaoleate (14C), polyglycerol (14C) monooleate and polyglycerol (14C) decaoleate
- Specific activity (if radiolabelling): 100 µci/g
- Locations of the label (if radiolabelling): oleic and eicosanoic acid: carbon 1
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: rats received the diet and were placed immediately into metabolism chambers designed for the collection of lymph, respiratory CO2, faeces and urine.
- Individual metabolism cages: yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: liquid diet
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: dosing solutions of the 14C-labelled compounds at 1% concentration were prepared by dissolving appropriate amounts in liquid diet containing sucrose, milk, solids, vitamins, salts, water and fat as described by Coots (1964) (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
REFERENCE
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 - Duration and frequency of treatment / exposure:
- 51 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1% for each of the 14C-labelled test substances
- No. of animals per sex per dose / concentration:
- 4 for each of the 14C-labelled test substances
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, lymph fluid, respiratory CO2. Lymph fluid was sampled by thoracic duct cannulation (Bollmann et al., 1948).
- Time and frequency of sampling: sampling of lymph fluid, urine, faeces and respiratory CO2 was each performed as a single fraction during the 51 h experimental period and started immediately after administration of the 14-labelled compounds in liquid food via gavage to thoracic-cannulated rats.
REFERENCE
Bollmann, J. L., Cain J. C., Grindley, J. H.. (1964). Techniques for the collection of lymph from the liver, small intestine, or thoracic duct of the rat. J Lab Clin Med., 33, 1349-1352 - Statistics:
- Means and standard errors for the analysed parameters (% of recovered radioactivity in CO2, urine, faeces, gastrointestinal contents, carcass, lymph and lymph lipids)
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- polyglycerol monooleate (14C): 92%
- Type:
- other: absorption in thoracic duct lymph
- Results:
- polyglycerol monooleate (14C): 75%
- Type:
- absorption
- Results:
- polyglycerol decaoleate (14C): 96%
- Type:
- other: absorption in thoracic duct lymph
- Results:
- polyglycerol decaoleate (14C): 68%
- Type:
- absorption
- Results:
- polyglycerol monoeicosanoate (14C): 65%
- Type:
- other: absorption in thoracic duct lymph
- Results:
- polyglycerol monoeicosanoate (14C): 54%
- Type:
- absorption
- Results:
- polyglycerol (14C) monooleate: 51%
- Type:
- other: absorption in thoracic duct lymph
- Results:
- polyglycerol (14C) monooleate: 2%
- Type:
- absorption
- Results:
- polyglycerol (14C) decaoleate: 36%
- Type:
- other: absorption in thoracic duct lymph
- Results:
- polyglycerol (14C) decaoleate: 5%
- Type:
- other: distribution in glycerides of thoracic duct lymph
- Results:
- polyglycerol monooleate (14C): 96%
- Type:
- other: distribution in glycerides of thoracic duct lymph
- Results:
- polyglycerol decaoleate (14C): 96%
- Type:
- other: distribution in glycerides of thoracic duct lymph
- Results:
- polyglycerol monoeicosanoate (14C): 94%
- Type:
- other: distribution in phospholipids of thoracic duct lymph
- Results:
- polyglycerol monooleate (14C): 3%
- Type:
- other: distribution in phospholipids of thoracic duct lymph
- Results:
- polyglycerol decaoleate (14C): 2%
- Type:
- other: distribution in phospholipids of thoracic duct lymph
- Results:
- polyglycerol monoeicosanoate (14C): 5%
- Type:
- other: distribution in sterol esters of thoracic duct lymph
- Results:
- polyglycerol monooleate (14C): 1%
- Type:
- other: distribution in sterol esters of thoracic duct lymph
- Results:
- polyglycerol decaoleate (14C): 2%
- Type:
- other: distribution in sterol esters of thoracic duct lymph
- Results:
- polyglycerol monoeicosanoate (14C): 1%
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The absorption of polyglycerol-labelled moieties of the polyglycerol esters via the lymphatic system was ≤ 5% in thoracic duct-cannulated rats. However total absorption was > 36% (see Table 2 under “Any other information on results incl. tables”), thus suggesting other pathways of absorption (e.g. via the portal vein). In contrast, a high absorption (≥ 54%) of oleate- or eicosanoate-labelled moieties of polyglycerol esters was found in the lymph of the thoracic duct. About 15-20% and 10% of the 14C from oleate and eicosanoate, respectively, were absorbed by pathways other than the thoracic duct.
- Details on distribution in tissues:
- Oleate-labelled moieties of polyglycerol esters were recovered in glycerides, phospholipids and sterol esters of the thoracic duct lymph with percentages of ≥ 96, ≥ 2 and ≥ 1%, respectively. Eicosanoate-labelled moieties of polyglycerol esters were incorporated into glycerides, phospholipids and sterol esters at percentages of 94, 5 and 1%, respectively (see Table 3 under “Any other information on results incl. tables”).
Any other information on results incl. tables
Table 2. Disposition of 14C by the thoracic duct-cannulated rat after administration of 14C-labelled polyglycerol esters (n = 4 rats per group; mean value ±SEM)
|
% of recovered radioactivity |
|||||
14C-labelled compounda |
CO2 |
Urine |
Faeces |
Gastrointestinal contents |
Carcass |
Lymph |
14C-labelled polyglycerol |
|
|||||
G10*-O1 |
1.5 ± 0.1 |
42.4 ± 7.1 |
45.6 ± 8.0 |
3.5 ± 2.7 |
5.1 ± 3.0 |
1.9 ± 0.4 |
G10*-O10 |
1.7 ± 0.1 |
25.6 ± 3.5 |
60.8 ± 6.3 |
3.1 ± 2.2 |
3.8 ± 1.5 |
5.0 ± 0.2 |
14C-labelled fatty acid esters of glycerol |
|
|||||
G10-O1* |
14.4 ± 4.0 |
1.0 ± 0.7 |
6.1 ± 3.7 |
1.6 ± 1.0 |
1.9 ± 1.1 |
75.0 ± 8.8 |
G10-O10* |
13.3 ± 0.7 |
1.4 ± 0.9 |
8.4 ± 5.6 |
2.3 ± 0.3 |
7.1 ± 4.8 |
67.5 ± 5.7 |
G10-E1* |
8.9 ± 1.0 |
0.4 ± 0.2 |
17.0 ± 13.6 |
18.3 ± 12.0 |
1.5 ± 0.2 |
54.2 ± 3.0 |
aG10= polyglycerol; O = oleic acid; E = eicosanoic acid; * = 14C-labelled moiety
Table 3. Incorporation of 14C-labelled fatty acids into various lymph lipid classes after administration of 14C-labelled polyglycerol esters (n = 4 rats per group; mean values)
|
% of recovered radioactivity |
||
14C-labelled fatty acid esters of glycerola |
Glycerides |
Phospholipids |
Sterol esters |
G10-O1* |
96.2 |
2.5 |
1.3 |
G10-O10* |
96.1 |
2.3 |
1.6 |
G10-E1* |
93.8 |
5.3 |
0.9 |
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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