Registration Dossier
Registration Dossier
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EC number: 298-190-5 | CAS number: 93778-52-0
Basic toxicokinetics
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:
- 2 001
- 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 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.
Constituent 1
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.
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