Registration Dossier

Administrative data

Endpoint:
dermal absorption
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
not applicable
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Model is based on accepted principles of skin permeation and diffusion of chemicals through a semi-permeable membrane. It was validated with an extensive database of experimentally measured permeation coefficients and is considered valid for substances with log Kow values in the range from 0 to 4. In this case it is used with a substance with a logKow clearly outside of this range and therefore it's validity is uncertain, at least from a quantitative perspective.
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
other: QSAR model
Title:
Skinperm version 3.0
Author:
ten Berge W
Bibliographic source:
http://home.planet.nl/~wtberge/

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
not applicable, QSAR method
GLP compliance:
no
Remarks:
not applicable, QSAR method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Physicochemical parameters used as per chapter 4. Water solubility 0.0001mg/l, molecular weight 445.

Test animals

Species:
human

Results and discussion

Any other information on results incl. tables

The model estimates the permeation rate for the substance to be 5.9 pg/cm2/hr. Since this substance is outside the range that has been validated, this quantitative figure must be used with caution. However, it does indicate that dermal uptake is likely to be negligible.

Applicant's summary and conclusion

Conclusions:
A QSAR model predicts that the permeation rate of the substance through skin is negligible.
Executive summary:

A QSAR model indicates that the permeation rate of the substance through skin is likely to be negligible.