Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: publication, read-across
Justification for type of information:
On the basis of all evaluated data, the similarity of all category members of the ISOCARB is justified on basis of the physico-chemical properties, toxicological and ecotoxicological profiles. There is convincing evidence that these chemicals possess an overall common category profile. ISOCARB are aliphatic branched carboxylic acids and include substances with carbon chain lengths of C11 to C24. Their only functional group is the carboxyl group, which they share in common. All ISOCARB have a single branching at the C2 position, where the branches differ in chain length from methyl to decyl.

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
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
- Name of test material (as cited in study report): docosanoic acid
- Physical state: white solid
- Analytical purity: 85.9 %
- Lot/batch No.: 60805X
- Storage condition of test material: The test substance was kept under room temperature before use.

Test animals

Species:
human

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: low-fat, natural foods
Details on exposure:
In a randomised, crossover, metabolic-ward study, 7 mildly hypercholesterolemic men were fed 3 natural food diets supplemented with behenate oil, palm oil, or high oleic acid sunflower oil. Mean serum lipid and lipoprotein concentrations and plasma triacylglycerol fatty acid comosition were determined druing final 4 d of each 3 week diet period.
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 men
Control animals:
no
Statistics:
The mean values obtained for the 3 dietary periods were compared by performing a repeated-measures analysis of variance (ANOVA). When the ANOVA showed the results of diets to be different, paired t tests wtih Bonferroni correction for multiple comparisons were peformed. After Bonferroni correction, statistical significance was set at a P value of 0.0167 (<0.05/3).

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Only approximately 30% of the dietary behenic acid was absorbed.
Details on distribution in tissues:
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.
Details on excretion:
Behenic acid was recovered in the feaces

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Behenic acid may be hydrolyzed shortly after absorption into shorter-chain saturated fatty acids.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
Executive summary:

Absorption: Only approximately 30% of the dietary behenic acid was absorbed.

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.

Metabolism: Behenic acid may be hydrolyzed shortly after absorption into shorter-chain saturated fatty acids.

Excretion: Behenic acid was recovered in the faeces.