Registration Dossier
Registration Dossier
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EC number: 220-701-7 | CAS number: 2871-01-4
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
According to the result of the key study (Hadfield, Klimisch 1, OECD 428, GLP), the test substance was considered to have slow and low dermal penetration property.
Key value for chemical safety assessment
- Absorption rate - dermal (%):
- 0.25
Additional information
One key study was available to assess the dermal penetration of the test substance (Hadfield, GLP compliant, OECD 428, 2005, Klimisch 1). The penetration and distribution of HC Red 3 has been measured in vitro through human skin, following the incorporation of [14C]-HC Red 3. The mixed formulation was applied to 12 human dermatomed skin membranes (nominally 400μm thick), 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 using natural sponges soaked in 3% Teepol. 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. The receptor fluid samples, sponges, tape strips, residual skin and donor chambers were analysed for radioactivity.
The results obtained in this study indicated that the penetration of HC Red 3 through human skin was very slow, only 0.25% (1.52μg/cm2) of the applied HC Red 3 was regarded as available. Washing the formulation from the skin surface at 0.5h removed the vast majority of the test substance.
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