Registration Dossier
Registration Dossier
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EC number: 232-462-6 | CAS number: 8047-15-2
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: publication
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The published data are reliable with restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Quillaja Saponins, Summary Report
- Author:
- EMEA (The European Agency for the Evaluation of Medicinal Products)
- Year:
- 1 996
- Bibliographic source:
- EMEA/MRL/055/95-Final, February 1996
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: no data
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Saponins
- EC Number:
- 232-462-6
- EC Name:
- Saponins
- Cas Number:
- 8047-15-2
- Molecular formula:
- not applicable UVCB
- IUPAC Name:
- Saponin
- Test material form:
- solid: crystalline
Constituent 1
- Radiolabelling:
- not specified
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- poor absorption after oral administration
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- poor absorption after oral administration
- Details on distribution in tissues:
- No saponins were detected in any of the blood samples. residues of saponins were found in the small intestine.
Transfer into organs
- Test no.:
- #1
- Transfer type:
- secretion via gastric mucosa
- Observation:
- no transfer detectable
Metabolite characterisation studies
- Metabolites identified:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
After oral administration saponins are not significantly absorbed since hydrolysation to sapogenins and sugars take place. Saponins are unlikely to cross the gut wall. - Executive summary:
After oral administration saponins are not significantly absorbed since hydrolysation to sapogenins and sugars take place. Saponins are unlikely to cross the gut wall.
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