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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
publication
Title:
Percutaneous absorption of parabens from cosmetic formulations
Author:
Dal Pozzo, A. and Pastori, N.
Year:
1996
Bibliographic source:
International Journal of Cosmetic Science 18, 57-66

Materials and methods

Principles of method if other than guideline:
The neat test substance or test substance dissolved in different vehicles was applied to human abdominal cadaver skin for 8 h. The experimental fluxes and the permeability constants were determined.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-hydroxypropyl benzoate
- Analytical purity: no data
Radiolabelling:
no

Test animals

Species:
other: human abdominal cadaver skin
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
other: not applicable
Vehicle:
other: the test substance was applied unchanged or dissolved in 4 different vehicles: water, 50% propylene glycol (PG) in water, 20% polyethylene glycol (PEG) 400 in water, liquid paraffin
Duration of exposure:
8 h
Doses:
pure test substance: 200 mg/200 µL in acetone solution (corresponding to 1000 mg/mL)
dissolved in water: 0.37 mg/mL (saturated solution)
dissolved in 50% PG in water: 7.4 mg/mL (saturated solution)
dissolved in 20% PEG 400 in water: 2.23 mg/mL (saturated solution)
dissolved in liquid paraffin: 0.19 mg/mL (saturated solution)
Control animals:
no

Results and discussion

Total recovery:
The test substance in a saturated aqueous solution resulted in an experimental flux of 4.77 µg/cm²*h and a permeability constant of 1.12.

Any other information on results incl. tables

Table 1: Skin permeation data of Propylparaben applied using different vehicles

 

Propylparaben in acetone

water

50% PG in water

20% PEG 400 in water

liquid paraffin

Concentration (mg/mL)

1000

0.37

7.4

2.23

0.19

Jmax(µg/cm²*h)

40.05

4.77

2.6

2.51

1.0

log Jn(cm/h*10³)

-1.40

1.12

-0.45

0.05

0.72

Jmax: experimental flux

log Jn: permeability constant

Applicant's summary and conclusion