Registration Dossier

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
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

Constituent 1
Chemical structure
Reference substance name:
Sodium dodecylbenzenesulfonate
EC Number:
246-680-4
EC Name:
Sodium dodecylbenzenesulfonate
Cas Number:
25155-30-0
Molecular formula:
C18H30NaO3S
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 : 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.

Categories Display