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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented publication which meets basic scientific principles
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1975

Materials and methods

Objective of study:
excretion
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): Sodium dodecylbenzene sulphonate (DOBC)
- Molecular formula (if other than submission substance): C18H29NaO3S
- Molecular weight (if other than submission substance): 349.48
- Smiles notation (if other than submission substance):CCCCCCCCCCCCC1=CC(=CC=C1)S(=O)(=O)[O-].[Na+]
- InChl (if other than submission substance): 1S/C18H30O3S.Na/c1-2-3-4-5-6-7-8-9-10-11-13-17-14-12-15-18(16-17)22(19,20)21;/h12,14-16H,2-11,13H2,1H3,(H,19,20,21);/q;+1/p-1
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: organic salt
- Physical state: no data
- Analytical purity:chemically pure determined by thin layer chromatography and isotope dilution analysis.
- Radiochemical purity (if radiolabelling): radiochemically pure determined by thin layer chromatography and isotope dilution analysis
- Specific activity (if radiolabelling): 8.5 µCi/mg
- Locations of the label (if radiolabelling): 1-alkyl position
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
other: Colworth-Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100-120g
- Individual metabolism cages: yes

ENVIRONMENTAL CONDITIONS
- Air changes: 1.5 L/min

Administration / exposure

Route of administration:
other: intraperitoneal and subcutaneous
Vehicle:
other: solutions in 25% polyethylene glycol in water or in water only
Details on exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 or 0.5 mL.
- concentration (if solution): two test solutions of the [14C] DOBS were used, the first a 3 mM solution in 25% v/v Polyethylene Glycol 400 in water and a second a 3 mM suspension in water)

VEHICLE
- Justification for use and choice of vehicle (if other than water): test material is poor soluble in water
Duration and frequency of treatment / exposure:
single applications
Doses / concentrations
Remarks:
Doses / Concentrations:
8.69 µCi (1.02 mg/kg bw )
No. of animals per sex per dose / concentration:
3 (intraperitoneal)
3 (subcutaneous)
Control animals:
no
Positive control reference chemical:
None
Details on study design:
Not applicable
Details on dosing and sampling:
PHARMACOKINETIC STUDY (excretion)
- Tissues and body fluids sampled: urine, faeces, cage washes, expired air;
- Time and frequency of sampling: after 6 or 24 hours after test material administration.
Statistics:
Not reported

Results and discussion

Main ADME results
Type:
excretion
Results:
Most of the administered 14C was recovered in the urine at 24 h after dosing (78%). 22% and 1.5% of applied dose were recovered in carcasses and in faeces, respectively. <0.1% was measured in the expired air.

Toxicokinetic / pharmacokinetic studies

Details on excretion:
The rate and route of excretion of 14C from intraperitoneally administered [14C] surfactant solutions were the same as that from subcutaneously administered solutions. From the results the route of excretion of 14C surfactant giving the most sensitive indication of percutaneously absorbed surfactant was indicated.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
DOBC is excreted predominantly via urine.
Executive summary:

The excretion of DOBC surfactant was studied in Colworth-Wistar rats (Howes, 1975). The turnover of [14C]labelled DOBC was measured by injecting three animals intraperitoneally and three animals subcutaneously with 0.1 or 0.5 mL of surfactant solution. Two test solutions of the [14C] DOBS were used, the first a 3 mM solution in 25% v/v Polyethylene Glycol 400 in water and a second a 3 mM suspension in water. The administered dose resulted in 1.02 mg/kg bw. The animals were placed in sealed metabolism cages where urine, faeces and expired air were collected and monitored for 14C. After 6 or 24 h the animals were killed and the radioactivity in their carcasses was measured. The rate and route of excretion of 14C from intraperitoneally administered [14C] surfactant solutions were the same as that from subcutaneously administered solutions. Most of the administered 14C was recovered in the urine at 24 h after dosing (78%). 22% and 1.5% of applied dose were recovered in carcasses and in faeces, respectively. Under 0.1% radiactivity was measured in the expired air. From the results the route of excretion of 14C surfactant giving the most sensitive indication of percutaneously absorbed surfactant was indicated.