Hydroxido potassium zirconium carbonate, where there are 0, 1 or 2 hydroxide groups and 2, 3 or 4 potassium atoms and 2, 3 or 4 carbonate groups.

Endpoint summary

Description of key information

Repeat Dose Oral Toxicity:
This endpoint has been addressed using the read-across category approach to the surrogate substance ammonium zirconium carbonate. 
NOEL 1000 mg/kg/day, rat, OECD 422, Marr (2010).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The study was performed to a good standard with a sufficient level of information to assign a reliability score of 2 according to the principles for assessing data quality set out in Klimisch (1997).

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeat Dose Toxicity - Oral

The repeat dose toxicity of the test material has been addressed using the read across category approach to Ammonium Zirconium Carbonate. Marr (2010) has been provided as the key study, which was performed according to GLP and the standardised guideline OECD 422. 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 systemic effects. Therefore, the NOEL was considered to be 1000 mg/kg/day for systemic toxicity.

Repeat Dose Toxicity - Inhalation

In accordance with section 1 of REACH Annex XI repeated dose toxicity testing by inhalation administration (as required in section 8.6.1) does not appear scientifically necessary. Oral dosing of the surrogate substance, ammonium zirconium carbonate, to rats for a period of up to forty-five consecutive days at dose levels of up to the limit dose of 1000 mg/kg/day did not result in any toxicologically significant effects. Bearing in mind the low potential for inhalation exposure through manufacture and use of the substance and the possibility to predict low inhalation toxicity in the event of repeated exposure it is not considered justified to undertake an additional study.

Repeat Dose Toxicity - Dermal

In accordance with section 1 of REACH Annex XI repeated dose toxicity testing by dermal administration (as required in section 8.6.1) does not appear scientifically necessary. Oral dosing of the surrogate substance, ammonium zirconium carbonate, to rats for a period of up to forty-five consecutive days at dose levels of up to the limit dose of 1000 mg/kg/day did not result in any toxicologically significant effects. Additionally, no signs of systemic toxicity were observed in an acute dermal toxicity study (limit test at 2000 mg/kg). Bearing in mind the low potential for dermal exposure through manufacture and use of the substance and the possibility to predict low dermal toxicity in the event of repeated exposure it is not considered justified to undertake an additional study.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The key study (Marr, 2010) was performed on a surrogate substance and has been provided on the basis of read-across given the substances common ionic components, ZrO2. The study was performed using ammonium zirconium carbonate in a GLP compliant study conducted according to OECD guideline 422.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for repeated dose toxicity.