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Toxicological information

Basic toxicokinetics

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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:
2001
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Behenic acid
- Substance type: Organic
- Physical state: Solid
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:
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

Bioaccessibility 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.