Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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
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.