Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Budesonide was not genotoxic in the Ames test, the mouse lymphoma cell forward gene mutation (TK+/-) test, the human lymphocyte chromosome aberration test, the Drosophila melanogaster sex-linked recessive lethality test, the rat hepatocyte UDS test and the mouse micronucleus test.

Short description of key information:
Read-across from supporting substance Budesonide (CAS 51333-22-3)

Endpoint Conclusion:

Justification for classification or non-classification

Based on avaliable data on the supporting substance Budesonide, the substance "Pregna-1,4-diene-3,20-dione, 9,11-epoxy-21-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (9β,11β,16α)- (9CI)" was not classified as mutagen.