Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Expert judgement is combined with experimental data.

Data source

Reference
Reference Type:
review article or handbook
Title:
Ecology and Toxicology of Alkyl Polyglycosides.
Author:
Willing, A. et al.
Year:
2004
Bibliographic source:
Handbook of Detergents, Part B: Environmental Impact, Uri Zoller (editor)

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Principles of method if other than guideline:
No guideline exists.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): short-chain and long-chain alkyl-ß-glucosides
Radiolabelling:
yes

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration and frequency of treatment / exposure:
single exposure for 2 h
Doses / concentrations
Remarks:
Doses / Concentrations:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on dosing and sampling:
Relevant organs were radioanalyzed to determine specific organ distribution.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
No data on oral absorption but it is predicted to be high.
Details on distribution in tissues:
Stomach, intestines, liver, and kidney showed the highest levels of radioactivity for both compounds. Using simple extraction methods, it was shown that alkyl polyglycosides are readily cleaved into glucose and fatty alcohol, which is further oxidized to the corresponding fatty acid and partly incorporated in normal fat metabolism. Octyl-ß-D-[U-14C] glucosides were rapidly and almost completely transformed into hydrophilic metabolites during intestine and liver passage, whereas [1, 14C]-hexadecyl-ß-D-glucosides showed a much greater tendency toward lipophilic metabolism, resulting, e.g., in preferential identification in the liver of radiolabelled palmitoyl glycerides. These findings are underlined by the fact that ß-oxidation occurs more easily in medium-chain fatty acids than in long-chain fatty acids.
Details on excretion:
The hydrolysis of Alkylpolyglucosides as well as the oxidised metabolites are very polar and will be excreted rapidly via urine.

Metabolite characterisation studies

Metabolites identified:
not measured
Details on metabolites:
Alkylpolyglucosides will undergo hydrolysis. The resulting molecules, glucose and fatty alcohol, which is further oxidized to the corresponding fatty acid are incorporated in the citrus cycle and partly in normal fat metabolism, respectively.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Alkylpolyglucosides are predicted to be bioavailable via the oral route.
Alkylpolyglucosides undergo stepwise hydrolysis into glucose and fatty alcohol, which is further oxidized to the corresponding fatty acid are incorporated in the citrus cycle and partly in normal fat metabolism, respectively.
Excretion is assumed to occur mainly via renal elimination. Tissue accumulation can be excluded.