Registration Dossier

Administrative data

Endpoint:
dermal absorption
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
weight of evidence
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A well documented finite dose skin permeation calculator provided by US NIOSH

Data source

Reference
Reference Type:
other: Mathematical model
Title:
Finite Dose Skin Permeation Calculator
Author:
NIOSH
Year:
2012
Bibliographic source:
www.cdc.gov/niosh/topics/skin/finiteskinpermcalc.html

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This calculator estimates flux, skin concentrations, and amounts absorbed from any size dose applied to partially or fully hydrated skin. Calculations are based on the model described in the following references:
1. Kasting, G. B. and M. A. Miller (2006). "Kinetics of finite dose absorption through skin 2. Volatile compounds." Journal of Pharmaceutical Sciences 95(2): 268-280.
2. Miller, M. A. and G. B. Kasting (2010). "Toward a Better Understanding of Pesticide Dermal Absorption: Diffusion Model Analysis of Parathion Absorption in Vitro and in Vivo." Journal of Toxicology and Environmental Health 73(4): 284 - 300.
3. Kasting, G. B., M. A. Miller, et al. (2008). "A Spreadsheet-Based Method for Estimating the Skin Disposition of Volatile Compounds: Application to N,N-Diethyl-m-Toluamide (DEET)." Journal of Occupational and Environmental Hygiene 5(10): 633-644.
4. Wang, T.-F., G. B. Kasting, et al. (2007). "A multi phase microscopic model for stratum corneum permeability. II. Estimation of physicochemical parameters and application to a large permeability database." Journal of Pharmaceutical Sciences 96(11): 3024-3051.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
other: Predicted human

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Duration of exposure:
8 hours
Doses:
5 mg/cm2

Results and discussion

Percutaneous absorption
Dose:
5 mg/cm2
Parameter:
percentage
Absorption:
0.025 %
Remarks on result:
other: 8 hours
Remarks:
Calculated. See Other Information below

Any other information on results incl. tables

Calculated Permeant Distribution

Removed

0.0 %

0.0

μg/cm²

Evaporated

41.15 %

2057.591

μg/cm²

Surface

58.70 %

2935.177

μg/cm²

Stratum Corneum

4.17E-02 %

2.083

μg/cm²

Viable Epidermis

2.04E-02 %

1.019

μg/cm²

Dermis

6.62E-02 %

3.312

μg/cm²

Systemically Absorbed

2.54E-02 %

1.271

μg/cm²

Total

100.01 %

5000.000

μg/cm²

Applicant's summary and conclusion

Executive summary:

Using the US NIOSH Finite Dose Skin Permeation Calculator, systemic absorption of 9 -decenoic acid, methyl ester across partially hydrated human skin is predicted to be very low.