Registration Dossier
Registration Dossier
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EC number: 235-310-7 | CAS number: 12163-26-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Toxicity data on adverse effects on sexual function and fertility with magnesium diniobate are not available, thus the reproductive toxicity will be addressed with existing data on the individual constituents magnesium and niobium.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Magnesium diniobate
Magnesium diniobate is not expected to impair fertility, since the two constituents magnesium and niobium do not adversely affect fertility. Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.
Magnesium
Magnesium is involved in DNA replication and the overall functioning of cells and therefore necessary for reproduction. Additionally, it has several known positive effects on fertility in men and women as well as essential functions in human development during pregnancy. Based on the role of magnesium in human fertility, magnesium is considered not toxic to reproductive organs.
Niobium
In a GLP-conform test according to OECD TG 422, adverse effects were not observed for the reproductive function (sperm measures) and performance as well as for clinical signs, mortality, body weight, body weight changes, food consumption, haematology, clinical chemistry, neurobehavioural examinations, organ weights, gross pathology, and histopathology in male and female rats after oral administration of up to 1000 mg/kg bw/day of diniobium pentaoxide. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity and reproduction/developmental toxicity based on the experimental conditions of this screening study is ≥ 1000 mg/kg bw/day for male and female rats.
Justification for classification or non-classification
Magnesium diniobate is not to be classified according to Regulation (EC) 1272/2008 as toxic for reproduction via effects on fertility due to a complete absence of adverse effects for its constituents magnesium and niobium.
Additional information
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