Registration Dossier
Registration Dossier
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EC number: 203-845-5 | CAS number: 111-20-6
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Tissue Uptake and Oxidation of Disodium Sebacate in Man.
- Author:
- Mingrone G., Greco AV., Bertuzzi A., Arcieri-Mastromattel E., Tacchino RM., Marino F., Finotti E., Castegneto M.
- Year:
- 1 991
- Bibliographic source:
- J. Parenteral and Enteral Nutrition Vol 15, No. 4b, 454-459
Materials and methods
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium sebacate
- EC Number:
- 241-300-3
- EC Name:
- Disodium sebacate
- Cas Number:
- 17265-14-4
- Molecular formula:
- C10H18O4.2Na
- IUPAC Name:
- disodium sebacate
- Test material form:
- solid
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- Blood samples were collected during and after disodium sebacate infusion at intervals of 30 min and serum concentrations were deterrmined by HPLC.
Excreted radioactivity (µCi /min) was measured by bubbling the expired air into an apparatus containing 3 mEq hyamine to trap CO2 from a 20-L Douglas-bag.
CO2 production and O2 consumption were measured before starting the infusion, 4 h, and 8 h after starting the infusion.
24 h nitrogen excretion in urine was obtained. The respiratory quotient and the percent of calories derived from lipid oxidation were calculated by indirect calorimetry. - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: constant i.v. infusion
TYPE OF EXPOSURE MEASUREMENT: Blood samples
EXPOSURE LEVELS: 99 mmole
EXPOSURE PERIOD: 8 h
POSTEXPOSURE PERIOD: 24 h
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:
overnight-fasting healthy male
Results and discussion
- Results:
- The disodium serbacate serum level at the plateau phase was (mean ±SD) 4.54 ±0.71 µmol/mL, the overall rate of tissue uptake was 180.89 ±4.50 µmol/min, and the percent oxidation was 6.14 ±0.44 %.
At the end of the infusion the RQ dropped to 0.839 ±0.043, the percent of calories due to sebacate oxidation was 1.59 ±0.52 %, and the calories derived from lipids increased to 37.77 ±12.90 %.
Applicant's summary and conclusion
- Conclusions:
- A definite amount of the disodium sebacate infused is oxidized in human tissues.
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