Registration Dossier

Administrative data

Description of key information

A GLP-compliant oral gavage combined repeat dose toxicity study with reproduction / developmental toxicity screening test in the rat has been conducted in accordance with OECD Guideline 422 (1996). No treatment-related effects were observed at dose levels up to and including 1000 mg/kg/day. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Oral administration of Ammonium Zirconium Carbonate to rats for a period of up to forty-five consecutive days at dose levels of up to 1000 mg/kg/day did not result in any treatment-related sytemic effects.

Therefore, the “No Observed Effect Level” (NOEL) was considered to be 1000 mg/kg/day for systemic toxicity. Given the absence of effects in the this study it is not considered necessary to undertake further repeated dose toxicity testing of the substance, either via dermal or inhalation exposure or over extended exposure periods.

Justification for classification or non-classification

There were no treatment-related systemic effects at dose levels of up and including 1000 mg/kg/day in a combined repeat dose toxicity study with reproduction / developmental toxicity screening test in the rat and there is no other data available suggesting that the substance has the potential to be harmful by repeat exposure. On this basis the substance is not classified for repeat dose toxicity.