Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 248 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
Lowest, and therefore most conservative, LD50.

Justification for selection of acute toxicity – dermal endpoint
No mortality observed in the study. NOAEL=2000 mg/kg bw

Justification for classification or non-classification

The lowest acute LD50 was 2248 mg/kg bw in an acute oral toxicity test and no mortality was observed in an acute dermal toxicity test up to 2000 mg/kg bw. These values are well above the threshold criterion for acute toxicity classification under CLP or DSD.

Therefore, based on read-across of oral toxity from losartan potassium and weight of evidence from dermal study with registration substance losartan free acid is not classified as hazardous for acute toxicity.