Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information

According to the result of the main key study (OECD guideline 414, GLP, Klimisch 1), the NOAEL oral route of maternotoxicity and embryotoxicity of the registered item 1-phenyl-3-methyl-5-pyrazolone was defined as 200 mg/kg/day. A preliminary study was performed a dose range-finding (OECD 414 method, non GLP, Klimisch 2).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Reliability 1, the NOAEL is in fact a NOEL at 200 mg/kg bw/d

Justification for classification or non-classification

According to the result of the main key study (OECD guideline 414, GLP, Klimisch 1), the NOAEL oral route of maternotoxicity and embryotoxicity of the registered item 1-phenyl-3-methyl-5-pyrazolone was defined as 200 mg/kg/day.