Registration Dossier

Administrative data

Description of key information

No specific neurotoxicity studies have been performed however, neurological endpoints (i.e. arena testing, FOBs and motor activity assessment), as well as brain weight and microscopic examination of the brain and a peripheral nerve (sciatic) were all included in a fully compliant 90-day toxicity study in rats. None of these parameters were affected following treatment for 13 consecutive weeks at dosages up to and including 7500 ppm (521 mg/kg bw/day in males, and 533 mg/kg bw/day in females). In addition, no effects on brain weight and no microscopic abnormalities were observed in a 28-day inhalation study even at the highest tested concentration of 21.53 mg/m3, which was lethal to some animals.

The registered substance is not considered to possess any neurotoxic potential.

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
521 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
high quality database

Effect on neurotoxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
21.53 mg/m³
Study duration:
subacute
Species:
rat

Effect on neurotoxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A fully compliant subchronic 90-day dietary toxicity study, up to 7500 ppm, did not reveal any treatment-related effects at FOBs and motor activity assessments, and no changes in brain weight or histopathology. No effects on brain weight and histopathology were noted in a 28-day inhalation study, including a lethal concentration. The test material is not considered to possess any neurotoxic potential.

Justification for classification or non-classification