2-butyloctanoic acid

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

read-across based on grouping of substances (category approach)

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.

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

Test material information

Constituent 1

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

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 / concentration:

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.