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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Human epidermal in vitro permeation test (IVPT) analyses of alcohols and steroids
Author:
Azadeh Alinaghi, Ana Macedo, Hanumanth S. Cheruvu, Amy Holmes, Michael S. Roberts
Year:
2022
Bibliographic source:
International Journal of Pharmaceutics 627 (2022) 122114

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
yes
Remarks:
In this work, the study authors explore whether human skin IVPT studies carried out with different receptor conditions and temperatures for a series of aliphatic alcohols and steroids may be made comparable by appropriate adjustment.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Propan-1-ol
EC Number:
200-746-9
EC Name:
Propan-1-ol
Cas Number:
71-23-8
Molecular formula:
C3H8O
IUPAC Name:
propan-1-ol
Specific details on test material used for the study:
Radiolabeled (14C) aliphatic alcohols (ethanol, propanol, pentanol, heptanol and decanol) with ranging activities from 2 to 55 mCi/mmol were purchased from American Radiolabeled Chemicals (St. Louis, MO, USA), diluted in their respective unlabeled alcohol (HPLC grade, Sigma, NSW, Australia) and further diluted in PBS 7.4 (Sigma-Aldrich, NSW, Australia) for use.
Radiolabelling:
yes

Results and discussion

Any other information on results incl. tables

Jss (µg.cm− 2.h− 1) 25 ◦C (PBS 7.4) = 1.4 ± 0.6 


Jss (µg.cm− 2.h− 1) 25 ◦C (2 %w/v BSA) = 1.4 ± 0.6 


kp′ (cm.h− 1) × 10^3 25 ◦C (PBS 7.4) = 2.0 ± 0.9


kp′ (cm.h− 1) × 10^3 25 ◦C (2 %w/v BSA) = 2.0 ± 0.5


Conc. mg/mL = 0.6


Jss = Apparent steady-state flux, kp ′ = apparent permeability coefficient, both presented as mean ± SD for PBS 7.4 (phosphate buffered saline pH 7.4) and 2 %w/v BSA (bovine serum albumin) and Conc. = concentration of the alcohols that permeated through human epidermal membrane over 4–10 h (n = 4–5)

Applicant's summary and conclusion