Registration Dossier
Registration Dossier
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EC number: 268-084-3 | CAS number: 68002-71-1 This substance is identified by SDA Substance Name: C16-C18 trialkyl glyceride and SDA Reporting Number: 19-001-00.
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- 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:
- Unnamed
- Year:
- 1 981
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The absorption of fully hydrogenated soybean oil was measured in a 15 d feeding study by analysis of fecal unabsorbed fat.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C16-18
- EC Number:
- 268-084-3
- EC Name:
- Glycerides, C16-18
- Cas Number:
- 68002-71-1
- Molecular formula:
- C55H98O6
- IUPAC Name:
- Glycerides, C16-18
- Details on test material:
- - Name of test material (as cited in study report): Fully hydrogenated soybean oil (CAS N° 8016-70-4, EC N° 232-410-2); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-18’
- Other: Test material was made fully hydrogenated using a commercial nickel-based catalyst
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Weight at study initiation: 200 g
- Housing: The animals were housed in individual stainless steel wire-mesh cages
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1
- Humidity (%): 50±5%
- Photoperiod (h dark / h light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Normal diet without any other fat source - Duration and frequency of treatment / exposure:
- 15 d; daily ad libitum in food
Doses / concentrations
- Dose / conc.:
- 15 other: %
- No. of animals per sex per dose / concentration:
- 10 animals/sex/group
- Control animals:
- other: yes, 15% soybean oil
- Positive control reference chemical:
- Not applicable
- Details on study design:
- - Rationale for animal assignment: Random
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption)
- Tissues and body fluids sampled: Feces
- Time and frequency of sampling: For the final 10 d, the feces were collected for unabsorbed fat analysis. - Statistics:
- All of the data were analyzed by the Analysis of Variance and partitioned by the Tukey minimum significant difference method.
Results and discussion
- Preliminary studies:
- Not performed
Main ADME results
- Type:
- absorption
- Results:
- 6±4%
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Low absorption was observed for fully hydrogenated soybean oil (6±4% ) with respect to soybean oil (94±2%).
- Details on distribution in tissues:
- Not performed
- Details on excretion:
- Not performed
Toxicokinetic parameters
- Test no.:
- #1
- Toxicokinetic parameters:
- other: % absorption = 6±4%
Metabolite characterisation studies
- Metabolites identified:
- not measured
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, test substance was poorly absorbed after dietary administration in rats.
- Executive summary:
The oral absorption of the constituent 'glycerides, C16 -18' (as fully hydrogenated soybean oil) was measured in a 15 d feeding study by analysis of fecal unabsorbed fat.
Diet containing 15% of the constituent was fed to 10 Sprague-Dawley rats/sex for 15 d. Control group was fed with 15% soybean oil for same duration. Feces were collected for the final 10 d, and analysed for unabsorbed fat. Low absorption was observed for the test substance (6±4% ) compared to soybean oil (94±2%).
Under the test conditions, the constituent was poorly absorbed after dietary administration in rats (Nolen 1981).
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