Registration Dossier

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)

Data source

Reference
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Version / remarks:
draft version
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylresorcinol
EC Number:
210-155-8
EC Name:
2-methylresorcinol
Cas Number:
608-25-3
Molecular formula:
C7H8O2
IUPAC Name:
2-methylbenzene-1,3-diol

Test animals

Species:
pig

Results and discussion

Any other information on results incl. tables

In vitro absorption/percutaneous penetration out of a basic hair dyeing formulation with and without a developer (excised pig skin)

Guideline: OECD draft 428

Species: pig

Group: 0.38 mm dermatomed skin from 2 animals; total 8 chambers per each of 3 experiments

Test substance 2 -methylresorcinol; (radio-labelled [14C] 2 -methylresorcinol)

Batch: SAT030630; (radio-labelled SAT 030759)

Purity: / (radio-labelled: 99.65%)

Dose: 1.8% in formulations with coupler and/or hydrogen peroxide; 1.8% in water

Receptor fluid: Physiological buffered saline

In this in vitro dermal penetration study in pig skin the amount of substance systemically available from a standard cream formulation with or without hydrogen peroxide was found to be 0.85 ± 0.78 μg/cm² (0.45%) and 8.38 ± 5.41 μg/cm² (4.48%), respectively and 32.2 ± 11.91 μg/cm² (17.18%) for the aqueous solution.

The maximum value observed in the experiment was 2.07 μg/cm² with hydrogen peroxide and 12.09 μg/cm² without hydrogen peroxide.

Comment: skin penetration of the formulation with and without H2O2 differs greatly but is highest in water.

Applicant's summary and conclusion