Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
10 mg/m³
Study duration:
subacute
Species:
rat

Additional information

In oral repeated administration a NOEL of 50 mg/kg bw/day was determined from a 9 weeks study. The major treatment -related effects are clinical signs, but not methemoglobinemia, and weight loss. In a vapour inhalation 28 day assay a NOAEC was determined at 10 mg/m3 in rats, due to slight methemoglobinemia and haematological effects seen at 90 mg/m3.

No specific target organ for systemic toxicity could be identified for the oral route. For the inhalation route, haematology findings are considered the most relevant.


Repeated dose toxicity: inhalation - systemic effects (target organ) cardiovascular / hematological: other

Justification for classification or non-classification