Registration Dossier
Registration Dossier
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EC number: 200-021-7 | CAS number: 50-24-8
Endpoint summary
Administrative data
Description of key information
Additional information
Prednisolone is an organic white to almost white crystalline solid in normal conditions. (Farmabios; Hawley's condensed chemical dictionary 14th Edition)
It melts between 235 (Hawley's Condensed Chemical Dictionary 14th Edition.) and 246 °C (Farmabios analysis MP36892), at 101.3 kPa, with decomposition. Density was estimated to be 1055 g/cm3at 25 °C. (Book of chemical and physical property data) The vapour pressure was estimated to be about 0.00000000913 kPa at 25 °C. (EPISUITE v.4.0)
Prednisolone is slight soluble in water (0.223 g/L) and soluble in some organic solvents (alcohol, chloroform, acetone, methanol and dioxane) (The Merck index, 11th Edition)
By auto flammability as well as flammability analysis prednisolone is not flammable. (Eurofins ASTM E2021 -09 and ASTM E1491 -06; Eurofins)
Particle size determination was performed on two dust sample of prednisolone. The following values have been obtained (Farmabios analysis MP 36892 and MP37103):
Lot MP36892: D10 = 2.849 μm; D50 = 19.518 μm; D90 = 49.524 μm.
Lot MP37103: D10 = 1.162 μm; D50 = 4.92 μm; D90 = 13.956 μm.
In accordance with Column 2 of REACH Annex VII, a study for explosiveness and oxidising properties does not to be conducted as no group have correlated with these properties.
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