Sulfonation products of disodium sulfite with (esterification products of C9-11 (branched and linear) Alkyl Polyglycosides with maleic anhydride)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study cited by: - GRAS EXEMPTION CLAIM, 2007. Alkyl Polyglucoside Surfactants; - Hill, K., W.v. Rybinski, and G. Stoll, 9. Toxicology of Alkyl Polyglucosides, in Alkyl Polyglucosides, Technology, Properties and Applications, VCH, Editor 1997: Weinheim - New York, Basel, Cambridge, Tokyo.

Data source

Reference

Reference Type:

secondary source

Title:

Metabolism of Orally Administered β-Glycosides in the Mouse.

Author:

Weber N and Benning H

Year:

1984

Bibliographic source:

GRAS EXEMPTION CLAIM, 2007. Alkyl Polyglucoside Surfactants; Hill et al., 1997. Toxicology of Alkyl Polyglucosides.

Materials and methods

Principles of method if other than guideline:

Three types of radiolabeled alkyl glycosideswere administerd by gavage to mice, in order to evaluate their metabolism.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl maltoside (carbon chain of alcohol is C12; the glucoside is part of Glucopon 600 UP, 425 UP, 650)

IUPAC Name:

Dodecyl maltoside (carbon chain of alcohol is C12; the glucoside is part of Glucopon 600 UP, 425 UP, 650)

Constituent 2

Reference substance name:

Hexadecyl glucoside (carbon chain of alcohol is 16; part of Glucopon 600 UP, 425 UP, 650)

IUPAC Name:

Hexadecyl glucoside (carbon chain of alcohol is 16; part of Glucopon 600 UP, 425 UP, 650)

Constituent 3

Reference substance name:

Octyl glucoside (carbon chain of alcohol is C8; part of Glucopon 215 UP, 225 DK, 425 UP, APG 325)

IUPAC Name:

Octyl glucoside (carbon chain of alcohol is C8; part of Glucopon 215 UP, 225 DK, 425 UP, APG 325)

Test material form:

not specified

Radiolabelling:

yes

Test animals

Species:

mouse

Strain:

NMRI

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Results and discussion

Main ADME results

Main ADME results 1

Type:

absorption

Results:

Two hours after treatment, stomach, intestins, liver and kidney showed the hghest concentration of radioactivity.

Main ADME results 2

Type:

distribution

Results:

Two hours after treatment, stomach, intestins, liver and kidney showed the hghest concentration of radioactivity.

Main ADME results 3

Type:

metabolism

Results:

Using extraction methods, it was shown that Alkyl Polyglucosides are readily cleaved into glucose and fatty alcohol, which is further oxidized to the corresponding fatty acid and partially incorporated in normal fat metabolism.

Main ADME results 4

Type:

excretion

Results:

The high level in the urine indicated rapid degradation and elimination of the test items.

Metabolite characterisation studies

Metabolites identified:

yes

Details on metabolites:

The β-glycosidic bond between glucose and long-chain alcohol is hydrolyzed. Glucose and glucose oligomers enter the carbohydrate metabolic pathway and are catabolized. Long-chain alcohols are acylated to wax esters, then either incorporated into ether glycorlipids or oxidized to fatty acids. Finally, the fatty acids are either esterified to ester glycolipids or oxidized to acetate.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
Radiolabeled dodecyl maltoside, octlyl glucoside and hexadecyl glucoside were administered by gavage to female NMRI mice. two hours after treatment the animals were sacrificed and relevant organs were analyzed to determine distribution in specific organs. Stomach, intestines, liver and kidney showed the highest concenration of radioactivity for the compounds. Alkyl polyglycosides are transformed into glucose and fatty alcohol, which enter the metabolic pathways of carbohydrates and fatty acids, respectively. No toxic intermediates were formed. The high level in the urine indicated rapid degradation and elimination of the test items.

Executive summary:

Radiolabeled dodecyl maltoside, octlyl glucoside and hexadecyl glucoside were administered by gavage to female NMRI mice. Two hours after treatment the animals were sacrificed and relevant organs were analyzed to determine distribution in specific organs. Stomach, intestines, liver and kidney showed the highest concenration of radioactivity for the compounds. Alkyl polyglycosides are transformed into glucose and fatty alcohol, which enter the metabolic pathways of carbohydrates and fatty acids, respectively. No toxic intermediates were formed. The high level in the urine indicated rapid degradation and elimination of the test items.