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9. For specimens which comprise or simulate indispersible solid material, a leaching assessment must be performed as follows—
(a)the specimen must be immersed for 7 days in water at ambient temperature. The volume of water to be used in the test must be sufficient to ensure that at the end of the 7-day test period the free volume of the unabsorbed and unreacted water remaining must be at least 10% of the volume of the solid test sample itself. The water must have an initial pH of 6-8 and a maximum conductivity of 1 mS/m at 20°C;
(b)the water with specimen must then be heated to a temperature of (50 ± 5)°C and maintained at this temperature for 4 hours;
(c)the activity of the water must then be determined;
(d)the specimen must then be stored for at least 7 days in still air at a temperature not less than 30°C and relative humidity of not less than 90%;
(e)the specimen must then be immersed in water of the same specification as in (a) above and the water with the specimen heated to (50 ± 5)°C and maintained at this temperature for 4 hours;
(f)the activity of the water must then be determined.
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