Registration Dossier

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:
1996
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
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.