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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A repeated dose toxicity study with magnesium diniobate is not available, thus the repeated dose toxicity will be addressed with existing data on the individual constituents magnesium and niobium.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Magnesium diniobate

Since a repeated dose toxicity study is not available specifically for magnesium diniobate, information on the individual constituents magnesium and niobium will be used for the hazard assessment and when applicable for the risk characterisation of magnesium diniobate.

Magnesium

Magnesium, as one of the essential elements, is known for its U-shaped dose- response relationship. The U-shape dose-response describes a biphasic response to exposure to increasing amounts of a substance or condition. According to a recently published EFSA scientific opinion on dietary reference values for magnesium the daily recommendation for magnesium is between 300 and 350 mg/day. Variation in intake recommendations depends on age, sex and health. However, redistribution, reduced intake, reduced intestinal absorption, increased gastrointestinal loss or increased renal loss are causes of hypomagnesaemia. Magnesium deficiency entirely due to reduced dietary intake in otherwise healthy subjects is very uncommon. This kind of deficiency is mainly observed in patients with diseases. Magnesium deficiency has severe effects on human health, due to its biological role, e.g. as essential cofactor in enzymatic processes. Excessive use of magnesium as laxatives, antacids or daily magnesium supplementation has only mild and reversible effects on human health. However, magnesium deficiency is more relevant to human health than magnesium overdoses.

Niobium

A combined repeated dose toxicity study with reproduction/developmental toxicity screening test according to OECD Guideline 422 in which diniobium pentaoxide was administered by gavage to Wistar rats at dose levels of 250, 500 and 1000 mg/kg bw/day is considered as the key study for repeated dose toxicity. After oral administration of 250, 500, and 1000 mg/kg bw/day of diniobium pentaoxide, adverse test item related effects were not observed for clinical signs, mortality, body weight, body weight changes, food consumption, haematology, clinical chemistry, neurobehavioural examinations, organ weights, gross pathology, and histopathology. In conclusion, the No Observed Adverse Effect Level (NOAEL) for the substance was concluded to be ≥ 1000 mg/kg bw/day for male and female rats.

Justification for classification or non-classification

Magnesium diniobate does not require a classification for STOT-RE since adverse effects are not expected up to the limit dose based on infornation available for its constituents.