Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity. 


Justification for selection of Effect on fertility via oral route:
An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be ≥1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity.

Justification for selection of Effect on fertility via inhalation route:
An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be ≥1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity.

Justification for selection of Effect on fertility via dermal route:
An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be ≥1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity. 


Justification for selection of Effect on developmental toxicity: via oral route:
An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be ≥1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity.

Justification for selection of Effect on developmental toxicity: via inhalation route:
An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be ≥1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity.

Justification for selection of Effect on developmental toxicity: via dermal route:
An OECD 422 test has been performed with zirconium acetate. The test results indicate that zirconium acetate is a substance of low toxicological potential as the NOAEL for reproduction/developmental toxicity was considered to be ≥1000 mg/kg bw/day, the highest dose tested (based on anhydrous zirconium acetate). In addition, and based on the assessment of the available data, low absorption of zirconium acetate is expected. Taking into account all available information, it can be concluded that zirconium acetate neither affects fertility nor mating performance in rats of both sexes at doses up to and including 1000 mg/kg bw/day. On this basis, it can be concluded that zirconium has a low potential for systemic reproductive toxicity. In addition, the SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity.

Justification for classification or non-classification