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EC number: 822-334-3 | CAS number: 52233-31-5
An in vivo skin irritation test was conducted to assess the potential of the test substance, Subtilisin, batch FPF 312/20, to cause skin irritation. The procedure of the US Federal Register, § 191.11, 17 Sept. 1964, was followed. 0.5 mL of the test material formulation was applied under semiocclusive conditions to the closely-clipped dorsa of 12 New Zealand White rabbits for 24 hrs. The study was conducted before GLP was implemented but the principles was the same and state of the art was followed. The study concluded that the test substance, Subtilisin, was a mild irritant to the skin. Concentration of solution applied was 3.4% expressed as active enzyme protein.
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