Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

According to the results of the dermal penetration study (OECD method 428, GLP compliant, Klimisch 2), the dermal penetration rate of the registered substance 2-amino-4-hydroxyethylaminoanisole sulfate was 0.05%.

In the in-vitro basic toxicokinetics study, gastrointestinal permeability were studyied for the substance 2-amino-4-hydroxyethylaminoanisole sulfate using the TC-7 human intestinal epithelial cell line. A maximum amount of 0.712 ± 0.313 µg/cm2 of test substance was considered as biologically available.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
0.05

Additional information

Two in vitro studies were available to estimate the cutaneous absorption and oral bioavailability of the substance. The cutaneous absorption (in-vitro) of 1.5% 2 -Amino-4 -hydroxyethylamino anisole sulfate in a typical hair dye formulation in the presence of hydrogen peroxide and a reaction partner (1-Hydroxyethy1 4,5-Diamino Pyrazole Sulfate) was determined following methods according to the OECD Guideline 428 (Skin Absorption: In Vitro Method). This key study was performed with pigs skin in diffusion cell. Amount of test substance was quantified in rinsing solution 30 minutes after contact with test item and in the lower skin and the receptor fluid after 72h after test item exposure in oxidative formulations. The dermal absorption rate was 0.05%.

The second key study was performed to estimate the test substance bioavailability across the intestinal barrier in the A-B (apical to basolateral) Permeability assay using human intestinal epithelial cell line (TC-7). The uptake of the test substance from apical to basolateral cavity was analyzed by HPLC-MS/MS.  A relative percent absorption of the test substance was indicated by the comparison with reference compounds. Interpretation of the results indicated highly permeability : Papp of 73.3 x10E-6 cm/s. Therefore, the gastrointestinal tract could be considered to be of 100%.