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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
25 mg/kg bw/day
Study duration:
Quality of whole database:
 There were no toxicologically significant effects of treatment on body weight, food consumption, clinical pathology, electrocardiography, physical examinations, ophthalmoscopic examinations, or gross microscopic post-mortem findings. A treatment-related increase in the incidence of vomiting and fecal abnormalities was apparent in the 125 mg/kg/day dogs. These antemortem findings and microscopic evidence of lymphocytic infiltration in the gastric mucosa suggested a dose-related gastrointestinal irritation. There were clinical signs suggestive of gastrointestinal irritation, increased salivation and emesis in the 25 mg/kg group at slightly higher frequency than the control group. There were no other effects in this group. Based upon the results of this study, at 125 mg/kg/day, the NOAEL is 25 mg/kg/day and the NOEL was 5 mg/kg/day.

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Longest duration and higher organism. high quality study.

Justification for classification or non-classification

Substance is not classified as repeat dose toxicant based on NOAEL of 25 mg/kg-bw/day for effects on gastrointestinal irritation at high doses. Therefore, by read-across, losartan free acid is not classified as repeat dose toxicant according to CLP or DSD.