Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
dermal absorption
Type of information:
(Q)SAR
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:
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:
Tetramethylene dimethacrylate
EC Number:
218-218-1
EC Name:
Tetramethylene dimethacrylate
Cas Number:
2082-81-7
Molecular formula:
C12H18O4
IUPAC Name:
butane-1,4-diyl bis(2-methylacrylate)
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1,4-Butandiol dimethacrylate

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 2.895 μg/cm²/h; the relative dermal absorption is low

Any other information on results incl. tables

Based on a molecular weight of 226.27 g/mol and a g Kow of 3.1, the predicted flux of 1,4 -BDDMA is 2.895 μg/cm²/h; the relative dermal absorption is low.

Applicant's summary and conclusion

Conclusions:
The dermal absorption of 1,4-BDDMA is predicted to be low; the predicted flux is 2.895 μg/cm²/h.
Executive summary:

The dermal absorption (steady-state flux) of 1,4 -BDDMA has been estimated by calculation using the principles defined in the Potts and Guy prediction model.

Based on a molecular weight of 226.27 g/mol and ag Kow of 3.1, the predicted flux of 1,4 -BDDMA is 2.895 μg/cm²/h; the relative dermal absorption is low.