Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Under the conditions of this study, where 1 H-Tetrazol-5- amine-, N-IH-tetrazol-5-yl-, monoammonium salt  as administered orally once daily for
28 consecutive days at 0, 100, 300, or 1000/600 mg/kg/day, the no-observed-adverse-effect- level (NOAEL) was 300 mg/kg/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
300 mg/kg bw/day
Study duration:
Quality of whole database:
Only one GLP-study is available.

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The study is reliable without restrictions.

Justification for classification or non-classification