Registration Dossier
Registration Dossier
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EC number: 222-823-6 | CAS number: 3622-84-2
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption, other
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
Data source
Reference
- Reference Type:
- other: Software Report
- Title:
- Estimation Programs Interface for Microsoft Windows, EPI Suite version 4.0
- Author:
- EPA DERMWINv2.02
- Year:
- 2 013
- Bibliographic source:
- U.S. Environmental Protection Agency,Office of Pollution Prevention and Toxics, Washington, D.C., U.S.A.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Dermal Exposure Assessment: Principles and Applications. EPA/600/8-91-011B, January 1992, Interim Report. U.S. Environmental Protection Agency, Exposure Assessment Group, Office of Health and Environmental Assessment, Washington, DC,USA
- Version / remarks:
- USEPA 1992
- Principles of method if other than guideline:
- The Dermal Permeability Coefficient Program (DERMWIN) v2.02 estimates the dermal permeability coefficient (Kp), the dermally absorbed dose per event (DAevent) and Dermal Absorbed Dose (DAD) of organic compounds via water contact.
The Kp, DAevent and DAD estimation methodology was taken directly from the US EPA document (and supplemental Excel spreadsheet):
USEPA. 2004. Risk Assessment Guidance for Superfund (RAGS), Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment) Interim. Document and spreadsheet available online at:http://www.epa.gov/oswer/riskassessment/ragse/index.htm
The estimation methodology in DERMWIN v2.00 is an update of the method and equations used in previous versions of DERMWIN that were based on the U.S. EPA document "Dermal Exposure Assessment: Principles and Applications" (USEPA, 1992). - GLP compliance:
- no
Test material
- Reference substance name:
- N-butylbenzenesulphonamide
- EC Number:
- 222-823-6
- EC Name:
- N-butylbenzenesulphonamide
- Cas Number:
- 3622-84-2
- Molecular formula:
- C10H15NO2S
- IUPAC Name:
- N-butylbenzenesulfonamide
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): N-n-Butylbenzenesulphonamide
- Substance type: mono constituent substance - organic
- Physical state: clear, colourless liquid
- Analytical purity: 99.93%
- Lot/batch No.: 201705080023
- Expiration date of the lot/batch: 08/05/2019
- Storage condition of test material: Controlled room temperature (15-25°C, <70% relative humidity, protected from humidity (stored in a tightly closed container))
- Impurities (identity and concentrations):
0.051% water
0.001% butylamine
7 ppm total chlorine
- Composition of test material, percentage of components: 99.93 % N-n-butylbenzenesulphonamide
- Purity test date: Not provided
- Production date: 08/05/2017
Constituent 1
- Radiolabelling:
- no
Administration / exposure
- Details on study design:
- QSAR
Results and discussion
- Total recovery:
- The Dermal Permeability Coefficient Program (DERMWIN° v2.02 estimates the dermal permeability coefficient (Kp), the dermally absorbed dose per event (DAvent) and Dermal Absorbed Dose (DAD) of organic compounds via water contact.
The following values were obtained on the bases of the maximum water solubility of BBSA.
kp(est):0.00341 cm/hr
DA(event): 0.0037 mg/cm²- event (duration 4.02 hr)
DAD: 0.391 mg/kg-day (70 kg adult, water contact)
Percutaneous absorption
- Remarks on result:
- other: kp(est):0.00341 cm/hr; DA(event): 0.0037 mg/cm²- event (duration 4.02 hr); DAD: 0.391 mg/kg-day (70 kg adult, water contact)
Applicant's summary and conclusion
- Conclusions:
- The dermal permeability coefficient (kp), the dermal absorbed dose per event ( DAevent) and Dermal Absorbed Dose (DAD) are calculated by QSAR.
- Executive summary:
The Dermal Permeability Coefficient Program (DERMWIN° v2.02 estimates rhe dermal permeability coefficient (Kp), the dermally absorbed dose per event (DAvent) and Dermal Absorbed Dose (DAD) of organic compounds via water contact.
The following values were obtained on the bases of the maximum water solubility of BBSA.
kp(est):0.00341 cm/hr
DA(event): 0.0037 mg/cm²- event (duration 4.02 hr)
DAD: 0.391 mg/kg-day (70 kg adult, water contact)
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