Alkylbenzenesulphonic acid compound with alkanolamine

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

the tested substance is the acid part of the compound

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1983

Materials and methods

Objective of study:

excretion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

8 male Wistar rats (160-200g) were given a single i.p. dose of 384.7 μg sodium alkylbenzene-[14C]sulfonate (DBS) (2.26±0.15 mg/kg bw) in a 0.6% physiological NaCl solution. Excretion of14C in feces and urine was monitored for 10 days.

GLP compliance:

not specified

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: compact

Details on test material:

14C-labelled Sodium dodecylbenzene sulfonate(DBS) : It was synthesized by Attar et al. from [14C]benzene, with a specific radioactivity of 5 mCi/mmol and radiochemical purity > 98%. - Attar et al.(Synthese von Natrium- Dodecylbenzol-14C-Sulfonat, Chemosphere,4(1978), 339-343)

Radiolabelling:

yes

Remarks:

14C-labelled Sodium alkylbenzene sulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

male Wistar rats(160-200g)

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

other: 0.6% physiological NaCl solution

Details on exposure:

14C-labelled Sodium alkylbenzene sulfonate was mixed homogeneously into a powdered rat chow. The [14C]DBS-treated diet and the drinking water were given daily ad lib.

Duration and frequency of treatment / exposure:

10days

Doses / concentrations

Remarks:

Doses / Concentrations:
single i.p. dose of 0.385mg [14C]DBS per rat(2.26 +/- 0.1 5 mg/kg bw).

No. of animals per sex per dose / concentration:

8 male rats

Control animals:

yes

Details on study design:

8 male Wistar rats (160-200 g) were kept in individual metabolism cages that allowed separate collection of urine and feces. Each rat was given a single i.p. dose of 0.3847 mg [14C]DBS in a 0.6% physiological NaCl solution. Excretion of 14C in feces and urine was monitored for 10 days.

Details on dosing and sampling:

8 male rats each received a single i.p. dose of 0.3847 mg [14C]DBS per animal resulting in a dose of 2.26 +/- 0.15 mg/kg bw.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on excretion:

Within 10 days after dosing, the animals excreted 94.5% of the dose applied, 84.7% in the first 24h.

Metabolite characterisation studies

Metabolites identified:

yes

Details on metabolites:

Analysis of feces and urine for the acid and its metabolites :Approx. 90% of the 14C in feces and 65% in urine samples, collected from the long–term and the i.p. study, respectively, could be extracted. By means of column chromatography, a polar metabolic fraction was purified and isolated by t.l.c. techniques. Unchanged DBS could not be detected either in feces or in urine extracts. No further attempts were made to identify the polar metabolites. The metabolic studies with rhesus monkeys by Crosswell were confirmed with respect to the fact that no unchanged acid was excreted in the urine. Michael showed that 19% of LAS excreted in the feces of rats was not metabolized following a single oral dose. From the present long-term feeding and the single i.p. experiments with rats, however, it is obvious that the 14C activity in feces too, consisted only of a polar fraction.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
Single i.p. application of 0.385 mg [14C]acid/rat (2.26 +/- 0.15 mg/kg bw) resulted in a total elimanation of 94.5% within 10 days. 84.7% of the dose was elimenated in the first 24 h. All fecal and renal [14C]acid-derived activity consisted of highly polar metabolities.

Executive summary:

8 male Wistar rats (160-200g) were given a single i.p. dose of 384.7 μg sodium acid-[¹⁴C]sulfonate (DBS) (2.26±0.15 mg/kg bw) in a 0.6% physiological NaCl solution. Excretion of¹⁴C in feces and urine was monitored for 10 days.Within 10 days after dosing, the animals excreted 94.5% of the dose applied, 84.7% in the first 24h. i.p. treatment resulted in a minor¹⁴C elimination in the feces(35.0±4.6%) on the first day of the experiment, whereas renally excreted radioactivity amounted to 49.7±5.7%. From days 2-10 of the excretion study, however, the percentage of radioactive products in the feces wassignificantly higher than in the urine.The results of this experiment showed that, independent of the route of administration, the daily excretion of radioactive products occurs mainly in the feces with the exception of the first day of the i.p. experiment, when the peak of¹⁴C elimination was in the urine.