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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
The justification document on the read across category approach is included in IUCLID section 13.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, 4-C20-24 (even numbered) sec-alkyl derivs.
EC Number:
701-015-1
Cas Number:
2156592-72-0
Molecular formula:
C9H12SO3(CH2)n n=17-21
IUPAC Name:
Benzenesulfonic acid, 4-C20-24 (even numbered) sec-alkyl derivs.
Test material form:
other: liquid
Details on test material:
The test substance is a brown viscous liquid with sulfurous odor.

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
readily absorbed
Type:
excretion
Results:
primarily via urine

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The test substance is considered to be readily absorbed in the gastrointestinal tract.
Details on excretion:
The test substance is considered to be rapidly excreted primarily via urine, but also in bile and feces.

Applicant's summary and conclusion

Conclusions:
No recently generated toxicokinetic data is available for the target substance. Two studies are published with the category substance LABS Na, where LABS Na was observed to be readily absorbed from the gastrointestinal tract and primarily excreted in urine (but also in bile and feces). LABS Na had no bioaccumulation potential.
Executive summary:

No recently generated toxicokinetic data is available for the target substance. The toxicokinetic assessment is mainly based on known physicochemical and toxicological characteristics of the compounds. Supporting literature data was published for one substance in the category, LABS Na. Two toxicokinetic studies are performed with this substance which were considered reliable with restrictions (Klimisch score 2):

1.    The absorption, distribution, metabolism and elimination of LABS Na (radioactively labeled with 35S) were studies in male CR rats, after administration as an aqueous solution (Michael, 1968). The compound was readily absorbed from the gastrointestinal tract (80-90% of the dose administered) and primarily excreted in the urine. Very little was found in the lymph, so transport of LABS Na is probably by way of portal venous blood. There is considered to be no bioaccumulation potential based on the study results.

2.    The disposition of radioactivity was studied in single and repeated oral doses of [14C]LABS Na to rhesus monkeys (Cresswell et al, 1978). The results confirmed that LABS Na 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. LABS Na did not bioaccumulate in the tissues.

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