Sodium dodecylbenzenesulfonate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Elimination and biodistribution studies of [14C]Dodecylbenzene sulfonate in rats, following low dosing in the daily diet and single i.p. administration

Author:

Lay JP, Klein W and Korte F

Year:

1983

Bibliographic source:

Toxicology letters, 17(1983), 187-192

Materials and methods

Objective of study:

distribution

excretion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The [14C]DBS-treated diet and the drinking water were given daily ad lib. The chemical was mixed homogeneously into a powdered rat chow, resulting in an actual concentration of 1.40mg/kg diet. The measurement of food consumption and the collection of feces and urine were carried out in a 24h cycle

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dodecylbenzenesulfonate

EC Number:

246-680-4

EC Name:

Sodium dodecylbenzenesulfonate

Cas Number:

25155-30-0

Molecular formula:

C18H29NaO3S

IUPAC Name:

sodium dodecylbenzenesulfonate

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 dodecylbenzene sulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

male Wistar rats (120-140 g)

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Duration and frequency of treatment / exposure:

35 days

Doses / concentrations

Remarks:

Doses / Concentrations:
1.40 mg/kg

No. of animals per sex per dose / concentration:

12

Control animals:

yes

Details on study design:

The [14C]DBS was administered daily in the diet at a concentration of 1.4 mg/kg to male rats for 5 weeks. 6 rats were killed for the determination of radioactive residues in different tissues, while the remaining 6 rats served for a 1 week clearance study.

Details on dosing and sampling:

The [14C]DBS-treated diet and the drinking water were given daily ad lib. The chemical was mixed homogeneously into a powdered rat chow, resulting in an actual concentration of 1.40mg/kg diet. The measurement of food consumption and the collection of feces and urine were carried out in a 24h cycle.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on distribution in tissues:

Low levels of [14C]DBS-derived residues were detected in all tissues

Details on excretion:

14C excretion in feces : 0.635 +/- 0.036mg14C excretion in urine : 0.357 +/- 0.041mg

Metabolite characterisation studies

Metabolites identified:

yes

Details on metabolites:

Analysis of feces and urine for DBS 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 DBS/LAS 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
This chemical was administered daily in the diet at a concentration of 1.4 mg/kg to male rats for 5 weeks. From the total uptake (1.213 +/- 0.08mg/animal) of DBS, 81.8% was excreted during the dosing period; 52.4% in feces and 29.4% in urine. Low levels of [14C]DBS-derived residues were detected in all tissues analyzed on day 35 of the experiment. Following 1 week on normal diet only 7.8% of the nominally stored amount of 14C was found in the excreta

Executive summary:

Sodium Dodecylbenzene-[¹⁴C]sulfonate (DBS) was administered daily in the diet at a concentration of 1.4 mg/kg bw to male rats for 5 weeks. From the total uptake (1,213±0.08 mg/animal) of DBS, 81.8% was excreted during the dosing period: 52.4% in feces and 29.4% in urine. Low levels of Sodium dodecylbenzene sulfonate-derived residues were detected in all tissues in rat body analyzed on day 35 of the experiment. Colon is the tissue containing the highest amounts of radioactivity.