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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
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 the standardised guideline OECD 422 and according to GLP. It has been assigned a reliability score of 2 according to the principles for assessing data quality set out by Klimisch (1997).
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Toxic effects on fertility were determined in a repeat dose oral toxicity screening test (OECD 422), where ammonium zirconium carbonate was administered. Rats received doses up to 1000 mg/kg/day for a period of up to forty-five consecutive days. No adverse effects on reproductive performance were deducible up to the highest dose of 1000mg/kg/day. No treatment-related effects were detected in mating performance or fertility for treated animals of all dose groups compared to controls. Pregnancy was achieved for all females of all dose groups. No reproductive toxic effects at all were observed up to the high dose treatment of 1000mg/kg/day. Therefore the NOAEL was considered to be 1000 mg/kg/day for systemic toxicity.


Short description of key information:
Oral NOEL: 1000 mg/kg/day, OECD 422 combined repeat dose toxicity study with reproduction/development toxicity screening test in rats, conducted to GLP, Marr 2010.

Justification for selection of Effect on fertility via oral route:
The key study (Marr, 2010) was performed on a surrogate substance to the one being registered, potassium zirconium carbonate, 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 the standardised guidelines OECD 422.

Justification for selection of Effect on fertility via inhalation route:
The data obtained from oral exposure is deemed sufficient to address this endpoint.

Justification for selection of Effect on fertility via dermal route:
The data obtained from oral exposure is deemed sufficient to address this endpoint.

Effects on developmental toxicity

Description of key information
Oral NOEL: 1000 mg/kg/day, OECD 422 combined repeat dose toxicity study with reproduction/development toxicity screening test in rats, conducted to GLP, Marr 2010. This study is read-across from the surrogate substance Ammonium Zirconium Carbonate.
Effect on developmental toxicity: via oral route
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 the standardised guideline OECD 422 and according to GLP has been assigned a reliability score of 2 according to the principles for assessing data quality set out by Klimisch (1997).
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Quality of whole database:
The data obtained from oral exposure is deemed sufficient to address this endpoint.
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The assessment of the endpoint developmental toxicity/teratogenicity is based on an available OECD 422 study with the analogue substance ammonium zirconium carbonate.. Rats received doses up to 1000 mg/kg/day for a period of up to forty-five consecutive days.The test item was administered daily during 14 days pre mating, at maximum 14 days mating period in both male and female, during gestation period and up to early lactation for females.Dosing did not result in any treatment-related systemic effects, no adverse effects on reproductive performance and development of offspring up to day 4 of lactation were identified, therefore the no observed effect level (NOEL) for reproductive and development toxicity was considered to be 1000 mg/kg/day .

In accordance with REACH Annex XI a two-generation reproductive toxicity study (as required in section 8.7.3) does not appear scientifically necessary as the substance is of low toxicity (no evidence of toxicity seen in any of the tests available) and no adverse effects on reproductive performance and development of offspring up to day 4 of lactation were identified in a fully compliant OECD 422 study (read-across from the surrogate substance Ammonium Zirconium Carbonate) up to and including the limit dose of 1000 mg/kg bw/day.


Justification for selection of Effect on developmental toxicity: via oral route:
The key study (Marr, 2010) was performed on the surrogate substance Ammonium Zirconium Carbonate, and has been provided on the basis of read-across, given the substance's common ionic components. The study is GLP compliant and was conducted according to the standardised guideline
OECD 422.

Justification for selection of Effect on developmental toxicity: via dermal route:
The data obtained from oral exposure is deemed sufficient to address this endpoint.

Justification for classification or non-classification

Based on data from an OECD 422 study (i.e. Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test) performed with the surrogate substance Ammonium Zirconium Carbonate and in accordance with the criteria set out in Annex I of Regulation No. 1272/2008 the test material does not require classification for toxicity to reproduction. There is no evidence of adverse effects on sexual function and fertility or on development of offspring, caused by exposure. Furthermore, the substance is of low toxicity as demonstrated by a battery of acute toxicity and genotoxicity studies performed with the surrogate substance or the substance registered.

Additional information