Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
QSAR prediction:US EPA accepted QSAR method for chemicals properties assessment.

Data source

Reference
Reference Type:
other: QSAR model
Title:
EPI Suite v 4.1/DERMWIN v2.01
Author:
US EPA
Year:
2014
Bibliographic source:
http://epa.gov/oppt/exposure/pubs/episuite.htm

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Using the DERMWIN v2.01 QSAR model
GLP compliance:
no
Remarks:
not applicable to QSAR models

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Name of test material (as cited in study report:Potassium oxideCAS Number: 12136-45-7SMILES : KOKCHEM : Potash (potassium oxide)MOL FOR: O1 K2 MOL WT : 94.20
Radiolabelling:
no

Test animals

Species:
other: QSAR model,
Strain:
other: QSAR model,
Sex:
not specified

Administration / exposure

Type of coverage:
other: QSAR model
Vehicle:
other: QSAR model
Duration of exposure:
not applicable to QSAR models
Doses:
not applicable to QSAR models
No. of animals per group:
not applicable to QSAR models
Control animals:
no
Details on study design:
not applicable to QSAR models
Details on in vitro test system (if applicable):
not applicable to QSAR models

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Absorption in different matrices:
A QSAR model predicts that the permeability of Dipotassium oxide to human skin is quite low. The permeability coefficient was determined to be
0.000247 mg/cm2, which is around 1% of the skin penetration rate.
Predicted dermally absorbed coefficient was determined to be Kp (est)=1.96e-007 cm/hr.

Any other information on results incl. tables

A QSAR model predicts that the permeability of Dipotassium oxide to human skin is quite low. The permeability coefficient was determined to be 0.000247 mg/cm2, which is around 1% of the skin penetration rate.

Predicted dermally absorbed coefficient was determined to be Kp (est)=1.96e-007 cm/hr.

Applicant's summary and conclusion

Conclusions:
A QSAR model predicts that the permeability of Dipotassium oxide to human skin is quite low. The permeability coefficient was determined to be
0.000247 mg/cm2, which is around 1% of the skin penetration rate.
Predicted dermally absorbed coefficient was determined to be Kp (est)=1.96e-007 cm/hr.
Executive summary:

A QSAR model predicts that the permeability of Dipotassium oxide to human skin is quite low. The permeability coefficient was determined to be 0.000247 mg/cm2, which is around 1% of the skin penetration rate.

Predicted dermally absorbed coefficient was determined to be Kp (est)=1.96e-007 cm/hr.