Registration Dossier

Administrative data

Endpoint:
dermal absorption
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: QSAR estimations for dermal absorption tend to be conservative; however, they are not formally validated
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
other: database
Title:
EpiSuite DermWin V2.02
Author:
US EPA

Materials and methods

Principles of method if other than guideline:
The US-EPA EpiSuite reports DERMWINv.2.02 calculations. These are based on the Guy & Potts formula (GUY R.H. AND POTTS R.O., 1992. Structure-Permeability Relationships in Percutaneous absorption. J. Pharm. Sci.. 81: 603-604).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) 2,2'-thiobisacetate
EC Number:
246-131-9
EC Name:
Bis(2-ethylhexyl) 2,2'-thiobisacetate
Cas Number:
24293-43-4
Molecular formula:
C20H38O4S
IUPAC Name:
2-ethylhexyl 2-({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)acetate
Constituent 2
Reference substance name:
Di-2-EHTDG
IUPAC Name:
Di-2-EHTDG

Results and discussion

Percutaneous absorption
Parameter:
percentage
Absorption:
<= 10 %
Remarks on result:
other: 8 h
Remarks:
Concluded on the basis of the very low predicted absorption rate of 0.00003 mg/cm²/event.

Applicant's summary and conclusion

Conclusions:
It is concluded that absorption of Di-2-EHTDG through human skin in vivo within 8 h will be significantly less than 10%. This is a very conservative assumption that will be used for dermal risk assessments and setting of dermal DNELs.