Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
The substance is an intermediate of a corticosteroid; it may be teratogenic and embryocidal in rabbits and rats.
Read-across from supporting substance Budesonide (CAS 51333-22-3)

Toxicity to reproduction: other studies

Additional information

Budesonide was teratogenic and embryocidal in rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose on a body surface area basis).

Justification for classification or non-classification