Registration Dossier
Registration Dossier
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EC number: 915-640-4 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Experimental ADME data are not available for Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]. (Q)SAR programs were used to assess the ADME potential of two major alkylated components of Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate] in humans. The worst case predicted systemic bioavailability values for either of the two components were 32.6%, 0.00000715%, and 54.5% for oral, dermal, and inhalation exposures, respectively. Based on these systemic bioavailability predictions for DOWFAX 3B2/ Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate], very conservative oral and dermal bioavailability values were set as 50%, whereas systemic inhalation bioavailability was set to 100%. Parent's metabolites would be mainly excreted via urine and feces. On the basis of low volume of distribution, and predicted metabolism and excretion, Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate] is not expected to bioaccumulate in humans.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
See attached for full discussion of toxicokinetic potential and ADME report of Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate].
Experimental data on absorption, distribution, metabolism and excretion (ADME) are not available for the registered substance. To assess the ADME potential in humans of the major monoalky and dialkyl diphenyl ether sulfates mixture components: (disodium decyl(sulphonatophenoxy)benzenesulphonate and disodiumoxybis[decylbenzenesulphonate], (Q)SAR programs, ADMET Predictor (v7.2, Simulations Plus Inc, Lancaster, CA, USA), and GastroPlus (v9.0, Simulations Plus Inc, Lancaster, CA, USA) were utilized. See attached report for full discussion of toxicokinetic and ADME properties of Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate].
Based on the modelling results, a 30-year old person weighing 70 kg repeatedly orally exposed to 1 mg/kg/day Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate], is predicted to have an average systemic bioavailability of 29.5% and Cmax of 1.14 µg/mL. For inhalation exposure, the predicted values were 45.7% and 1.4 µg/mL, respectively; whereas for dermal exposure, those were 0% and 0 µg/mL, respectively.
The major predicted CYP-dependent Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate] metabolites were various monohydroxylates on the alkyl side chains; these can be further metabolized to water soluble glucuronides and sulfates conjugates. Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate] metabolites would be mainly excreted via urine and feces.
On the basis of predicted low volume of distribution, metabolism and excretion, Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate] is not expected to bioaccumulate in humans.
Based on the systemic bioavailability predictions for Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate], both oral and dermal bioavailability were conservatively set to 50%, whereas systemic inhalation bioavailability was adjusted to 100% for DNEL derivation.
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