Registration Dossier

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.