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Toxicological information

Basic toxicokinetics

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Administrative data

basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented peer-reviewed publication of contract laboratory study.

Data source

Reference Type:

Materials and methods

Objective of study:
Principles of method if other than guideline:
The disposition of radioactivity was studied in single and repeated oral doses of [14C]LAS to rhesus monkeys.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
LAS, sodium salt
LAS, sodium salt
Details on test material:
Alkyl benzene sulfonate, sodium salt; mean molecular weight 349 (supplied by the Japan Soap and Detergent Association)

Test animals

other: Macaca mulatta
Details on test animals or test system and environmental conditions:
Four (2 male, 2 female; 5 kg average body weight) adult rhesus monkeys (Macaca mulatta)

Administration / exposure

Route of administration:
other: single or repeated oral or subcutaneous
Doses / concentrations
Doses / Concentrations:
single or repeated oral (30, 150 or 300 mg/kg) or subcutaneous (0.1, 0.5 or 1 mg/kg) doses of 14C-LAS
No. of animals per sex per dose / concentration:
2 males and 2 females
Control animals:
not specified
Details on dosing and sampling:
Blood samples were collected for the excretion and plasma studies.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on distribution in tissues:
When 14C-LAS was injected into the skin, most of the radioactivity remained at the site of injection. No localization of radioactivity in any tissue occurred
Details on excretion:
After single 30 mg/kg oral doses the radioactivity was rapidly excreted, mostly during the first 24 hours. Means of 71.2% and 23.1% of the dose were excreted in the urine and feces, respectively, during 5 days. Similarly, after single 1 mg/kg subcutaneous doses, means of 64.1% and 10.9% were excreted in urine and feces, respectively, during 5 days, mostly during the first 24 hours. During the 120 hours after single oral (30 mg/kg) or subcutaneous doses (1 mg/kg) the average rate of excretion was between 63 and 74% in the urine and between 9 and 26% in the feces. No unchanged LAS was detected in urine samples after oral or subcutaneous doses (either single or repeated).

Metabolite characterisation studies

Metabolites identified:
Details on metabolites:
Five metabolites were excreted but they were not identified. Incubations with beta-glucuronidase/sulfatase did not affect the metabolites, indicating that the metabolites were probably not present as the corresponding conjugates.

Applicant's summary and conclusion

Interpretation of results (migrated information): no bioaccumulation potential based on study results
Executive summary:

The disposition of radioactivity was studied in single and repeated oral or subcutaneous doses of [14C]LAS to rhesus monkeys. Results show that LAS is rapidly absorbed, then rapidly metabolized and excreted, primarily in the urine but also in the bile and feces. No accumulation or localization of radioactivity or change in elimination was observed. LAS does not bioaccumulate in the tissues.