Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information
11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione 21-(hydrogen succinate) is an intermediate in the Methylprednisolone synthesis.
Methylprednisolone is a glucocorticoid.
Additional information

No reproductive toxicity studies are available on 11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione 21-(hydrogen succinate), but Glucocorticoid medication use during pregnancy has been associated in some but not all studies with an increased risk of cleft palate and impaired fetal growth.

Justification for classification or non-classification

Based on available data on glucocorticoids, the intermediate "11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione 21-(hydrogen succinate" was classified as toxic to reproduction cat. 1B, H360D (May damage the unborn child).