Registration Dossier

Administrative data

Endpoint:
dermal absorption
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Remarks:
Validated model calculation
Justification for type of information:
1. SOFTWARE no software used
2. MODEL (incl. version number) The prediction model used in this investigation for a set of methacrylate chemicals is based on an established model (Potts and Guy, 1992).
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL not stated in report
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL The “Relative Dermal Absorption” potential assigned to the predicted skin flux for methacrylate data is an arbitrary estimation of skin penetration potential, and is not a regulatory or OECD approved classification. It is based on several hundred chemicals tested in the same human skin model at the Central Toxicology Laboratory and Dermal Technology Laboratory. This database includes a wide variety of pharmaceutical, agrochemical and industrial chemicals tested over a 20 year period. The dermal absorption potential of a particular chemical substance is placed into one of six categories based on its skin permeability coefficient or its predicted (or actual) absorption rate
5. APPLICABILITY DOMAIN not explicitely stated in the report
6. ADEQUACY OF THE RESULT not explicitely stated in the report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Principles of method if other than guideline:
QSPeR - a statistically-derived linear and non-linear relationship between the steady-state permeability of a compound, usually measured from water, and various physicochemical descriptors and/or structural properties of the molecule.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
human

Results and discussion

Percutaneous absorption
Parameter:
rate
Absorption:
0.019 other: µg/cm2/h
Remarks on result:
other: Calculated permeation rate
Conversion factor human vs. animal skin:
Human skin model

Any other information on results incl. tables

This is a table with a predicted skin absorption rate for methacrylic anhydride and a reference chemical, methyl methacrylate.

Chemical Class

Test Chemical / Compound Identity

Acronym

Molecular Weight

Log P

Predicted Flux (µg/cm2/h)

Relative Dermal Absorption

Alkyl basic MA tier 1

Methyl methacrylate

MMA

100.12

1.38

64.422

Moderate

Multi-func hydrophil spec / single

Methacrylic anhydride

MAAH

154.16

1.23

0.019

Minimal

The calculated flux rate for MAAH of 0.0019 µg/cm²/h is much lower that that of the reference chemical methyl methacrylate with 64.422 µg/cm²/h indicating slower absorption through the skin.

Applicant's summary and conclusion

Conclusions:
In a calculation model for permeation through human skin the calculated flux rate for MAAH of 0.0019 µg/cm²/h is much lower that that of the reference chemical methyl methacrylate with 64.422 µg/cm²/h, indicating slower absorption through the skin.