Registration Dossier
Registration Dossier
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EC number: 204-399-4 | CAS number: 120-47-8
Dermal absorption
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:
- 1 996
- 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 abdominal cadaver skin for 8 h. The experimental fluxes and the permeability constants were estimated.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethyl 4-hydroxybenzoate
- EC Number:
- 204-399-4
- EC Name:
- Ethyl 4-hydroxybenzoate
- Cas Number:
- 120-47-8
- Molecular formula:
- C9H10O3
- IUPAC Name:
- ethyl 4-hydroxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): p-hydroxyethyl benzoate
- Analytical purity: no data
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: abdominal cadaver skin, not further specified
- 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: 0.91 mg/mL (saturated solution)
dissolved in 50% PG in water: 16.8 mg/mL (saturated solution)
dissolved in 20% PEG 400 in water: 4.6 mg/mL (saturated solution)
dissolved in liquid paraffin: 0.27 mg/mL (saturated solution) - Control animals:
- no
Results and discussion
- Total recovery:
- For the unchanged test substance, an experimental flux of 41.5 µg/cm²*h and a permeability constant of -1.38 was determined (see Table 1).
Any other information on results incl. tables
Table 1: Skin permeation data of Ethylparaben applied using different vehicles
|
Ethylparaben |
water |
50% PG in water |
20% PEG 400 in water |
liquid paraffin |
Concentration (mg/mL) |
1000 |
0.91 |
16.8 |
4.6 |
0.27 |
Jmax(µg/cm²*h) |
41.50 |
5.2 |
3.5 |
7.17 |
0.74 |
log Jn(cm/h*10³) |
-1.38 |
0.77 |
-0.68 |
0.19 |
0.64 |
Jmax: experimental flux
log Jn: permeability constant
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
