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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

 A 28- Day Repeated dose Oral toxicity (gavage) study in the rat. 
90 day repeated dose + reprotox parameters

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
1 000 mg/kg bw/day
Study duration:

Additional information

A 28 days subchronic test was performed with fyrolflex BDP. Oral administration of Fyrolflex BDP to rats for

28 consecutive days at dose level of 1000mg/kg/day produced no treatment related changes in the parameters measured. The NOAEL is therefore 1000mg/kg/day. Robust summary of the study is attached to the relevant endpoint records

In addition a 90 day repeated dose toxicity study was performed, including reprotox parameters, the NOAEL was here also 1000 mg/kg/day, and no reprotoxicity effects were found.


Justification for classification or non-classification

The substance should not be classifided based on NOAEL 1000mg/kg/day