Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TS-Freetext:
other dental series, Chemotechnique

Test animals

Species:
other: human skin model
Details on test animals 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 151.3 μg/cm²/h; the relative dermal absorption is high

Any other information on results incl. tables

Based on a molecular weight of 130.1 g/mol and a g Kow of 0.42, the predicted flux of HPMA is 151.3 μg/cm²/h; the relative dermal absorption is high.

Applicant's summary and conclusion

Conclusions:
The dermal absorption of HEMA is predicted to be high; the predicted flux is 151.3 μg/cm²/h.
Executive summary:
The dermal absorption (steady-state flux) of HEMA has been estimated by calculation using the principles defined in the Potts and Guy prediction model.

Based on a molecular weight of 130.1 g/mol and a logKow of 0.42, the predicted flux of HEMA is 151.3μg/cm²/h; the relative dermal absorption is high.