Registration Dossier

Diss Factsheets

Administrative data

skin irritation / corrosion
Adequacy of study:
weight of evidence
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:

Data source

Materials and methods

Test system

Details on study design:
Negative control: Dulbecco’s Phosphate Buffered Saline (DPBS) without CaCl2 and MgCl2
One plate (three tissues) was used as negative control; each tissue was treated with 30 µL DPBS buffer
Positive control: Sodium dodecyl sulphate (SDS), CAS No. 151-21-3, solution in deionised H2O, concentration 50 g/L
One plate (three tissues) was used as positive control; each tissue was treated with 30 µL SDS-solution
Test item: ground charcoal comprised of particles < 100 µm about 25 mg
One plate (three tissues) was used for treatment with the test item

Experimental performance:
After dosing the tissues with negative control, positive control and test item, they were incubated at 37 °C for 35 min. After 60 min a rinsing step and two incubation periods at 37°C over a total period of 42 h followed.
After incubation, a MTT assay was performed and formazan production was measured by a spectral photometer at 570 nm.

Results and discussion

Applicant's summary and conclusion