Registration Dossier

Administrative data

Description of key information

The oral gavage O.E.C.D. 407 Testing Guideline 28-day oral repeat dose conducted according to the GLP regulations is the most approriate repeated-dose study for the establishment of DNEL values.  The NOAEL from this study for systemic effects was 30 mg/kg/day. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
30 mg/kg bw/day

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
30 mg/kg bw/day

Additional information

The oral NOAEL was determined from a 28 -day repeat dose study to be 30 mg/kg/day. There was a slight decrease in the liver and kidney weights at the 10 mg/kg/day dose level, but this was thought to be incidental. The dermal NOAEL was determined from a ten day repeat dose study to be 30 mg/kg/day.

Justification for classification or non-classification