Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
dermal absorption
Type of information:
other: QSPR
Remarks:
Based on an established human skin model by Potts and Guy (Potts RO and Guy RH (1992). Predicting Skin Permeability. Pharm. Res. 9(5): 663-669)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Generally accepted calculation method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Principles of method if other than guideline:
The physicochemical parameters of MW, Log P and saturated aqueous solubility have been used in the evaluation of 56 methacrylate compounds. An output of predicted steady-state flux was calculated using the principles defined in the Potts and Guy prediction model. (Potts RO and Guy RH (1992). Predicting Skin Permeability. Pharm. Res. 9(5): 663- 669)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methacrylic acid, monoester with propane-1,2-diol
EC Number:
248-666-3
EC Name:
Methacrylic acid, monoester with propane-1,2-diol
Cas Number:
27813-02-1
Molecular formula:
C7H12O3
IUPAC Name:
2-hydroxypropyl methacrylate
Constituent 2
Reference substance name:
Reference substance 001
Details on test material:
TS-Freetext:
Purity: 98 %

Test animals

Species:
other: human skin model
Details on test animals or test system and environmental conditions:
not applicable; in silico modelling

Administration / exposure

Type of coverage:
other: not applicable; in silico modelling
No. of animals per group:
not applicable; in silico modelling

Results and discussion

Absorption in different matrices:
predicted flux 150.8 μg/cm²/h; the relative dermal absorption is high

Any other information on results incl. tables

Based on a molecular weight of 144.17 g/mol and a g Kow of 0.97, the predicted flux of HPMA is 150.8 μg/cm²/h; the relative dermal absorption is high.

Applicant's summary and conclusion

Conclusions:
The dermal absorption of HPMA is predicted to be high; the predicted flux is 150.8 μg/cm²/h.
Executive summary:

The dermal absorption (steady-state flux) of HPMA has been estimated by calculation using the principles defined in the Potts and Guy prediction model.

Based on a molecular weight of 144.17 g/mol and a logKow of 0.97, the predicted flux of HEMA is 150.8μg/cm²/h; the relative dermal absorption is high.

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