Sodium dodecylbenzenesulfonate

Endpoint summary

Link to relevant study record(s)

Reference

Reference 1

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

Objective of study:

distribution

excretion

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

Radiolabelling:

yes

Remarks:

14C-labelled Sodium dodecylbenzene sulfonate

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

male Wistar rats (120-140 g)

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Duration and frequency of treatment / exposure:

35 days

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.

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

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.

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.

Reference 2

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

Objective of study:

excretion

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 dodecylbenzene-[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

Radiolabelling:

yes

Remarks:

14C-labelled Sodium dodecylbenzene sulfonate

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

male Wistar rats(160-200g)

Route of administration:

intraperitoneal

Vehicle:

other: 0.6% physiological NaCl solution

Duration and frequency of treatment / exposure:

10days

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.

Details on excretion:

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

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.

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
Single i.p. application of 0.385 mg [14C]DBS/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]DBS-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 dodecylbenzene-[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.

Reference 3

Endpoint:

dermal absorption in vitro / ex 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

Qualifier:

no guideline followed

Principles of method if other than guideline:

-Radiolabelled test substance was applied (0.1 ml of a 3 mM solution) to samples of human abdominal skin from four female cadavars. Exposure time was 48 hrs. Analysis by liquid scintillation counting was done at 0.5, 1, 2, 3, 4, 6, 7, 8, 24, and 48 hrs. Penetration through human skin was negligible, with < 0.07% absorbed in 48 hrs.
- Method for preparation of dose suspensions: The test substance was added to the vehicle and homogenized and equilibrated at 40 degrees C for 24 hrs. The pH was then adjusted to 9.5 by adding 0.01 n NaOH or HCl.

GLP compliance:

not specified

Radiolabelling:

yes

Species:

human

Sex:

female

Duration of exposure:

48 hrs

Doses:

0.1 ml of 3 mM solution

No. of animals per group:

four skin samples

Details on study design:

- Method for preparation of dose suspensions: The test substance was added to the vehicle and homogenized and equilibrated at 40 degrees C for 24 hrs. The pH was then adjusted to 9.5 by adding 0.01 n NaOH or HCl.

Details on in vitro test system (if applicable):

SKIN PREPARATION
- Source of skin: human cadavars
- Ethical approval if human skin:
- Type of skin: abdominal
- Preparative technique: Epidermal samples were heated at 58 degrees C for 2 min. Samples were placed in 1 cm diamter penetration cells, and saline with 0.012% penicillin, 0.01% streptomycin was placed on both surfaces of the cells. The cells were equilibrated at 37 degrees C for 24 hrs.
- Membrane integrity check: Only cells with electrical resistance greater than 50,000 ohms were used.
- Storage conditions: -70 degree C

Signs and symptoms of toxicity:

not examined

Dermal irritation:

yes

Remarks:

some swelling was seen after 48 hrs of contact

Absorption in different matrices:

Only 30% of the test substance was removed by rinsing, with 70 % remaining associated with the skin.

Dose:

152.9 micrograms/cm^2

Parameter:

percentage

Absorption:

< 0.07 %

Remarks on result:

other: 2 hrs

Dose:

152.9 micrograms/cm^2

Parameter:

percentage

Absorption:

< 0.07 %

Remarks on result:

other: 6 hrs

Dose:

152.9 micrograms/cm^2

Parameter:

percentage

Absorption:

< 0.07 %

Remarks on result:

other: 48 hrs

Conclusions:

The in vitro penetration through human skin after a 48 hr exposure was < 0.07%.

Executive summary:

Radiolabelled test substance was applied (0.1 ml of a 3 mM solution) to samples of human abdominal skin from four female cadavars. Exposure time was 48 hrs. Analysis by liquid scintillation counting was done at 0.5, 1, 2, 3, 4, 6, 7, 8, 24, and 48 hrs. Penetration through human skin was negligible, with < 0.07% absorbed in 48 hrs.

Reference 4

Endpoint:

dermal absorption 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

Qualifier:

no guideline followed

Principles of method if other than guideline:

Radiolabelled test substance (3 mM solution) was applied to the shaved skin of female rats. The exposure lasted 15 min, after which is was rinsed off. After a 24 hr observation period during feces, urine, and expired air was collected, the animals were sacrificed and the excised skin was examined by autoradiography

GLP compliance:

not specified

Radiolabelling:

yes

Species:

rat

Strain:

other: Colworth-Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 100-120 g
- Housing: sealed metabolism cages
- Individual metabolism cages: yes

ENVIRONMENTAL CONDITIONS
- Air changes (per hr): 1.5 L/min

Type of coverage:

open

Vehicle:

other: Two test solutions were made: water, and 25% polyethylene glycol 400 in water.

Duration of exposure:

15 min

Doses:

- Nominal doses: 3 mM solution
- Dose volume: 0.2 ml

No. of animals per group:

no data

Control animals:

no

Details on study design:

DOSE PREPARATION
- Method for preparation of dose suspensions: The test substance was added to the vehicle and homogenized and equilibrated at 40 degrees C for 24 hrs. The pH was then adjusted to 9.5 by adding 0.01 n NaOH or HCl.

TEST SITE
- Preparation of test site: 24 hrs before application, hair was removed with clippers. Only animals with intact skin were used.
- Area of exposure: 7.5 cm^2

SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes: Animals were anesthetized during exposure. During the 24 hr observation period the animals were fitted with restraining collars or non-occlusive patches. Non-occlusive patches were made of three layers of surgical gauze 1 cm larger in each dimension than the exposure area. Over this, a stainless steel 100 mesh gauze was placed and secured with surgical strapping with holes punctured in it.

SAMPLE COLLECTION
- Collection of urine and faeces: for 24 hrs after exposure
- Collection of expired air: for 24 hrs after exposure

SAMPLE PREPARATION
- Preparation details: feces were freezed dried, carcasses were homogenized in a blender and then freeze dried

ANALYSIS
- Method type(s) for identification: Liquid scintillation counting, excised skin was examined by autoradiography

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Absorption in different matrices:

- Non-occlusive cover: < 2 micrograms
- Skin wash: 135 +/- 27 micrograms
- Skin test site: Heavy deposition was seen on the skin surface, and in the upper hair follicles, 11+/-4 micrograms
- Urine: none
- Faeces: none

Dose:

250 micrograms

Parameter:

percentage

Absorption:

< 0.3 %

Remarks on result:

other: 24 hrs after exposure

The amount of test substance that penetrated the skin was below the detection limit of 0.1 micrograms/cm2 or less than 0.3% of the initial dose.

Conclusions:

The in vivo penetration through rat skin after a 15 min exposure was < 0.3%.

Executive summary:

Radiolabelled test substance (3 mM solution) was applied to the shaved skin of female rats. The exposure lasted 15 min, after which is was rinsed off. After a 24 hr observation period during feces, urine, and expired air was collected, the animals were sacrificed and the excised skin was examined by autoradiography. Results show that the test substance, which is of low solubility, did not penetrate through the skin to any significant degree. The amount of test substance penetrating the skin was below the detection limit. The penetration through rat skin was < 0.3%.

Description of key information

Sodium dodecylbenzenesulfonate  has not bioaccumulation potential. After ingestion, Sodium Dodecylbenzene-[14C]sulfonate (DBS)  metabolites and are eliminated primarily via the urine and faeces

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Absorption rate - dermal (%):

0.3

Additional information

Sodium dodecylbenzenesulfonate has not bioaccumulation potential. After ingestion, Sodium Dodecylbenzene-[14C]sulfonate (DBS) metabolites and are eliminated primarily via the urine and faeces

Sodium dodecylbenzenesulfonate (read across from Dodecylbenzenesulfonic acid) is corrosive to skin and moderately irritating to eye (read across from Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)) . There is no evidence that the substance is a skin sensitizer.

 

Sodium dodecylbenzenesulfonate is of slightly order of acute oral toxicity and is not toxic for acute Dermal toxicity and acute inhalation toxicity.

 

Data on health risks following repeated exposure to Sodium dodecylbenzenesulfonate (read across from Dodecylbenzenesulfonic acid)indicate that Sodium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for Repeated dose toxicity.

 

Data on health risks following reproduction exposure to Sodium dodecylbenzenesulfonate (read across from Dodecylbenzenesulfonic acid)indicate that Sodium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for Reproduction toxicity.

 

 

Dietary exposure to Sodium dodecylbenzenesulfonate can occur from its use in food contact sanitizing solutions as an active ingredient, and as an inert ingredient in food-use pesticide products applied to agricultural crops, and animals. There are no currently registered products used in residential settings where to Sodium dodecylbenzenesulfonate is considered to be an active ingredient.

However, to Sodium dodecylbenzenesulfonate is used as an inert ingredient in pesticide products used in residential settings, including hard surface and carpet cleaners, lawn products, and pet products.

Post application residential exposure can occur in children from hand-to-mouth incidental oral exposure from treated surfaces, and contacting pets treated with flea and tick products.

Occupational exposure to to Sodium dodecylbenzenesulfonate can occur frommixing/loading/applicationactivities in various use sites, including agricultural food handling, andcommercial/institutional/industrial premises.

 

 

 

Toxicokinetics, Metabolism and Distribution

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.is the tissue containing the highest amounts of radioactivity(Layet al., 1983).

8 male Wistar rats (160-200g) were given a single i.p. dose of 384.7 μg sodium dodecylbenzene-[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(Layet al., 1983).

 

 

Conclusions

-Sodium Dodecylbenzene-[¹⁴C]sulfonate (DBS) is readily absorbed by the gastro-intestinal tract (82% of the administered dose)

-The sodium dodecylbenzenesulfonate absorption through intact skin is very poor (0.07-0.3% of the administered dose)

- Sodium Dodecylbenzene-[¹⁴C] sulfonate (DBS) is distributed to most organs, except uterus, and the major part is metabolised in the liver to sulfophenyl carboxyl acids

-Sodium Dodecylbenzene-[¹⁴C] sulfonate (DBS) metabolites are eliminated primarily via the urine and faeces.

 -Accumulation of Sodium Dodecylbenzene-[¹⁴C] sulfonate (DBS) or of its main metabolites has not been observed after repeated oral administration.

 

From the available data and the data on the closely related substances it is concluded that it is unlikely that Sodium dodecylbenzenesulfonate causes genetic effects or has an effect on male or female fertility and has not bioaccumulation potential.