Esterification product of castor oil fatty acids and pentaerythritol

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

This summary data reflects the opinion of the CIR Expert Panel that the data are valid and informative, adding to a weight of evidence approach for the potential of the test substance.

Data source

Reference

Reference Type:

publication

Title:

Safety Assessment of Pentaerythritol Tetraesters as Used in Cosmetics

Author:

Becker LC, Bergfeld WF, Belsito DV., et al.

Year:

2015

Bibliographic source:

Int. J. Toxicol 34(Suppl 2): 99S-112S

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ECHA Technical Guidance Document R.7a

Version / remarks:

Regulation EC No. 1907/2006

Principles of method if other than guideline:

Paper-based review of existing data

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-9, tetraesters with pentaerythritol

EC Number:

267-022-2

EC Name:

Fatty acids, C5-9, tetraesters with pentaerythritol

Cas Number:

67762-53-2

Molecular formula:

C25H44O8 to C41H76O8

IUPAC Name:

Reaction Products of fatty acids C5-C9 linear saturated and pentaerythritol

Specific details on test material used for the study:

Molecular weight: 529
Boiling point: 858 deg C
Vapour pressure: 1.6 x 10^-21 mm Hg at 25 deg C
log Kow: 16.7
Water solubility: 3.4 x 10^-15 g/L at 25 deg C

Results and discussion

Percutaneous absorption

Key result

Absorption:

>= 2 - <= 6 %

Any other information on results incl. tables

There were no experimental data discovered on the toxicokinetics of pentaerythritol tetraesters. However, due to the large size of the molecules and the high Pow of the pentaerythrityl tetra C5 -9 acid esters, it is not expected that these ingredients would penetrate the skin. For example, pentaerythryl tetrapelargonate has a log P > 16.7, a molecular weight > 500 and low solubility, so it is not likely to penetrate the skin. The dermal bioavailability of pentaerythrityl tetra C5 -9 acid esters was 2 -6%, based on a dermal toxicity study in rats.

Applicant's summary and conclusion

Conclusions:

An expert committee expects pentaerythrityl tetra C5 -9 acid esters would not penetrate the skin. Typical values would be in the range of 2-6% skin penetration.