Registration Dossier
Registration Dossier
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EC number: 208-031-3 | CAS number: 506-30-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Behenic acid is a cholesterol-raising saturated fatty acid in humans
- Author:
- Nilo B Cater and Margo A Denke
- Year:
- 2 001
- Bibliographic source:
- American Journal of Clinical Nutrition, 2001 v 73, No. 1, pp 41-44
Materials and methods
- Objective of study:
- toxicokinetics
- GLP compliance:
- no
Test material
- Reference substance name:
- Behenic acid (Docosanoic acid)
- IUPAC Name:
- Behenic acid (Docosanoic acid)
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- Molecular formula:
- C22H44O2
- IUPAC Name:
- docosanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Behenic acid
- Substance type: Organic
- Physical state: Solid
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: low-fat, natural foods
- Details on exposure:
- There were 3 diet periods, each lasting 3 wk. Patients lived in the metabolic ward during each dietary period and were provided with all foods and fat supplements.
Each dietary period was separated by ≥1 wk of an outpatient, ad libitum dietary period. During each of the final 4 d of each dietary period, blood was drawn after a 14-h fast. Mean lipid and lipoprotein concentrations from the final 4 d of each period were used as indicators of the subjects’ responses to the diets - Duration and frequency of treatment / exposure:
- 3 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
39.5% (by weight)
- No. of animals per sex per dose / concentration:
- 7
- Control animals:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Only approximately 30% of the dietary behenic acid was absorbed.
- Type:
- distribution
- Results:
- The appearance of behenic acid in plasma triacylglycerol fatty acids as a rough measure of absorption suggests that little if any behenic acid was absorbed and distributed intact to the fatty acid pool.
- Type:
- metabolism
- Results:
- Behenic acid may be hydrolyzed shortly after absorption into shorter-chain saturated fatty acids.
- Type:
- excretion
- Results:
- Behenic acid was recovered in the feaces
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not applicable since the use of the chemical is not in pharma products
- Details on distribution in tissues:
- Not applicable since the use of the chemical is not in pharma products
- Details on excretion:
- Not applicable since the use of the chemical is not in pharma products
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- shorter-chain saturated fatty acids
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- The present study suggests low bio-availability of behenic acid compared with other fatty acids.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
1) Absorption: Only approximately 30% of the dietary behenic acid was absorbed.
2) Distribution: The appearance of behenic acid in plasma triacylglycerol fatty acids as a rough measure of absorption suggests that little if any behenic acid was absorbed and distributed intact to the fatty acid pool.
3) Metabolism: Behenic acid may be hydrolyzed shortly after absorption into shorter-chain saturated fatty acids.
4) Excretion: Behenic acid was recovered in the feaces
From the above information and considering the low bio-availability of behenic acid compared with other fatty acids; it can be concluded that the bio-accumulation potential of behenic acid appears to be low. - Executive summary:
1) Absorption: Only approximately 30% of the dietary behenic acid was absorbed.
2) Distribution: The appearance of behenic acid in plasma triacylglycerol fatty acids as a rough measure of absorption suggests that little if any behenic acid was absorbed and distributed intact to the fatty acid pool.
3) Metabolism: Behenic acid may be hydrolyzed shortly after absorption into shorter-chain saturated fatty acids.
4) Excretion: Behenic acid was recovered in the feaces.
From the above information and considering the low bio-availability of behenic acid compared with other fatty acids; it can be concluded that the bio-accumulation potential of behenic acid appears to be low.
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