Diammonium bis[carbonato-O]dihydroxyzirconate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Additional information

The 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 toxicologically significant effects. Therefore, the “No Observable Effect Level” (NOEL) for animals of either sex was considered to be 1000 mg/kg/day for systemic toxicity. No treatment-related effects in the reproductive performance and offspring development up to day 4 of lactation were detected at dose levels of up to 1000 mg/kg/day. Therefore, the “No Observed Effect Level” (NOEL) was considered to be 1000 mg/kg/day for reproductive and developmental toxicity.

Short 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.

Effects on developmental toxicity

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.

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

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 effects in offspring up to day 4 of lactation.

Therefore, the “No Observed Effect Level” (NOEL) was considered to be 1000 mg/kg/day for developmental toxicity.

Justification for classification or non-classification

There were no treatment-related 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 a reproductive or developmental toxin. On this basis the substance is not classified for reproductive or developmental effects.