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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
dermal absorption
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
2013
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
results derived from a (Q)SAR model, with limited documentation / justification

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
estimation of dermal absorption using IH SkinPerm based on physico-chemical properties

References:
ten Berge WF. (2009). A simple dermal absorption model: Derivation and application. Chemosphere 75, 1440-1445

Wilschut, A., ten Berge, W. F., Robinson, P. J., McKone, T. E. (1995) Estimating skin permeation. The Validation of five mathematical skin permeation models. Chemosphere 30, 1275-1296 http://home.planet.nl/~wtberge/qsarperm.html
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[3-(dimethylamino)propyl]stearamide
EC Number:
231-609-1
EC Name:
N-[3-(dimethylamino)propyl]stearamide
Cas Number:
7651-02-7
Molecular formula:
C23H48N2O
IUPAC Name:
N-[3-(dimethylamino)propyl]octadecanamide
Radiolabelling:
no

Administration / exposure

Duration of exposure:
8 h
Doses:
9257 mg
As stated in the user manual for IH SkinPerm, 2 mL will cover 420 cm² skin surface (palms of 2 hands). Recalculation to an area of 2000 cm² skin surface, corresponding to 2 hands and forearms, resulted in 9.5 mL needed to cover this area, corresponding to 9257 mg of the test substance based on the density of 0.972 g/cm³.
No. of animals per group:
not applicable

Results and discussion

Percutaneous absorptionopen allclose all
Dose:
9257 mg
Parameter:
percentage
Absorption:
0 %
Remarks on result:
other: 8 h
Dose:
9257 mg
Parameter:
percentage
Absorption:
0 %
Remarks on result:
other: 24 h

Any other information on results incl. tables

 

Dermal absorption after:

8 h

24 h

Fraction absorbed [%]

0.0

0.0

Amount absorbed [mg]

0.038448 mg

0.11535

Max. dermal absorption rate [mg/cm²/h]

2.40E-06

2.40E-06

 

Chemical fate after:

8 h

24 h

Evaporation [%]

0

0

Deposition [%]

93.3

91.6

Stratum corneum [%]

6.7

8.4

Viable epidermis [%]

0

0

Applicant's summary and conclusion

Conclusions:
The dermal absorption of Stearic acid 3-(dimethylaminopropyl)amide has been estimated to be 0% (calculation using the IH SkinPerm QSAR model, version v1.03).
Executive summary:

The dermal absorption of Stearic acid 3-(dimethylaminopropyl)amide has been estimated by calculation using the IH SkinPerm (v1.03) model with the following parameters:

 

Scenario parameters:

Instantaneous deposition

Instantaneous deposition dose: 9257 mg

Affected skin area: 2000 cm²

 

Timing parameters:

Observation time:

8 h (start deposition 0 h, end time observation 8 h)

24 h (start deposition 0 h, end time observation 24 h)

The absorbed fractions have been estimated to be 0% after 8 and 24 h. The absorbed amounts have been estimated to be 0.04 and 0.12 mg after 8 and 24 h, respectively.  The maximum dermal absorption rate has been calculated to be 2.40E-06 mg/cm²/h.

 

Due to missing information about the applicability of the calculation model in respect to the substance under investigation the results should be treated with care.