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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