Registration Dossier

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

According to the results of the two key studies (Jäger, 2007, Klimisch 1, GLP, OECD 428 & Hadfield, 2005, Klimisch 2, GLP, OECD 428), the test item was considered to have a low dermal penetration rate across human skin. The penetration rate using human skin was defined at 2.01% of the applied dose.

Key value for chemical safety assessment

Absorption rate - dermal (%):

Additional information

Two key studies were available to assess percutaneous absorption of the test item :

-Jäger, 2007, OECD 428, GLP compliant, Klimisch 1 : This study was performed with the test item, HC Yellow No. 2, at 1.5% in Alkaline Cream Formulation. Two experiments were performed in which porcine ear skin was used in static diffusion cells. 20µL/cm2 of test item was applied in each skin sample, after 30 minutes of incubation, the skin was washed two times. Saline solution was used in receptor chamber. After 24 hours, stratum corneum was isolated by tape stripping, and test item was quantified in receptor chamber using HPLC method. Under the reported conditions, the dermal absorption of HC Yellow 2 was 6.06 ± 2.21 μg/cm2 or 4.71 ± 1.7 % .

-Hadfield, 2005, OECD 428, GLP compliant, Klimisch 2 : The penetration of HC Yellow 2 from a nominal 1% (w/w) formulation, has been measured in vitro through human skin, following the incorporation of [14C]-HC Yellow 2.The formulation was applied to 12 human dermatomed skin membranes , mounted in glass diffusion cells, at a nominal rate of 20mg/cm2. After a contact period of 30 minutes, the dose was washed from the surface of the skin. Samples of the receptor fluid (4% polyoxyethylene 20 oleyl ether solution in phosphate buffered saline) were taken at recorded intervals over a 48h period, during which time the applications remained unoccluded. At the end of the experiment, the surface of the skin was washed again and layers of stratum corneum removed using a tape stripping technique.  The receptor fluid samples, sponges, tape strips, residual skin and donor chambers were analysed for radioactivity. Under experimental condition of this study, the results obtained in this study indicated that the penetration of HC Yellow 2 through human skin was very slow, only 2.01% (4.02µg/cm2) of the applied HC Yellow 2 was regarded as systemically available.