Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
Year of publication: 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication

Data source

Reference
Reference Type:
publication
Title:
The design of a diet restricted in saturated very long-chain fatty acids: therapeutic application in adrenoleukodystrophy
Author:
Van Duyn MA, Moser AE, Brown FR, Sacktor N, Liu A, Moser HW
Year:
1984
Bibliographic source:
The american Journal of Clinical Nutrition, 40: 277-284

Materials and methods

Type of study / information:
Concentrations of Very Long-Chain Fatty Acids (VLCFA) in common food are reported
The study was designed to create a diet restricted in VLCFA for adrenoleukodystrophy patients
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
Determination of concentrations of VLCFA (C26:0) in 135 common foods and of C22:0 to C28:0 in VLCFA-unrestricted diets
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
other: not necessary
Details on study design:
Food analysis: Samples of foods were emulsified and 1 g each was mixed with 110 ml of CHCl3/CH3OH (1/1 v/v). The mixture was centrifuged and aliqots of the supernatant were subjected to acid methanolysis. 4 µg of C27:0 methyl ester was added as internal standard. The sample was dried, rinsed twice with benzene and 1 N methanolic HCL was added. Methanolisation was performed overnight at 75 °C. Fatty acid methylesters were extracted with hexane and separated by thin layer chromatography. The spots were scraped of and analysed for the amount of VLCFA by capillary GLC.
All procedures were performed in duplicates
Exposure assessment:
measured

Results and discussion

Results:
Range of concentrations for C26:0 in 135 common foods: 208.4 (peanut oil) to 0.001 (Hawaiian Punch) mg/100 g edible portion

VLCFA-content of a VLCFA-unrestricted diet (mg per daily portion):
C22:0: 253.8
C23:0: 9.4
C24:0: 115.9
C25:0: 3.4
C26:0: 14.8
C27:0: 0.3
C28:0: 0.4

Applicant's summary and conclusion

Conclusions:
The uptake of VLCFA (C22:0 to C28:0) in a VLCFA-unrestricted diet totals to about 450 mg per day.
Executive summary:

Common foods were analysed for the content of VLCFA. The concentrations of C26:0 in 135 common foods ranged from 208.4 (peanut oil) to 0.001 (Hawaiian Punch) mg/100 g edible portion. The uptake of VLCFA (C22:0 to C28:0) via a VLCFA-unrestricted diet totals to about 450 mg/day VLCFA.