Registration Dossier
Registration Dossier
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EC number: 947-854-9 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Sucrose esters were added to artificial gastric juice at a concentration or 0.4 or 1.25 mg/mL and incubated for up to 5 hrs. HPLC was then used to analyze the amount of sucrose esters degraded by the artificial gastric juice.
- Short description of test conditions: The artificial gastric juice had a pH of 1.2, and the incubation was done at 37 degrees C.
- Parameters analysed / observed: HPLC was then used to analyze the amount of sucrose esters degraded by the artificial gastric juice. - GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids C16-18 (even numbered), mono and di esters with Sucrose
- EC Number:
- 947-854-9
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Fatty acids C16-18 (even numbered), mono and di esters with Sucrose
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: artificial gastric juice
- Details on test animals or test system and environmental conditions:
- Artificial gastric juice with a pH of 1.2.
Administration / exposure
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.4 other: mg/mL artificial gastric juice
- Remarks:
- Sucrose monopalmitate and sucrose monostearate
- Dose / conc.:
- 1.25 other: mg/mL artificial gastric juice
- Remarks:
- S-1170
Results and discussion
Main ADME results
- Type:
- metabolism
- Results:
- Very little of the test substance was broken down by artificial gastric juice with 81.7-99.8% of the sucrose ester remaining after 5 hrs.
Any other information on results incl. tables
81.7% of sucrose monopalmitate remained after 5 hrs incubation in the artificial gastric juice, and 85% of sucrose monostearate remained after 5 hrs incubation. In the experiment done with S-1170, the compound most broken down by the artificial gastric juice was sucrose monopalmitate at 82.7% remaining, and the compound least broken down by artificial gastric juice was sucrose diester with 99.8% remaining after 5 hrs of incubation.
Applicant's summary and conclusion
- Conclusions:
- Small amounts of sucrose esters are digested by the stomach, but most is transported to the duodenum and small intestine without being degraded.
- Executive summary:
Sucrose esters were added to artificial gastric juice at a concentration or 0.4 or 1.25 mg/mL and incubated for up to 5 hrs. HPLC was then used to analyze the amount of sucrose esters degraded by the artificial gastric juice. 81.7 -99.8% of the test substance was not degraded by the artificial gastric juice, thus indicating that most of the sucrose esters pass into the duodenum and small intestine unchanged.
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