Registration Dossier
Registration Dossier
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EC number: 939-960-9 | CAS number: 39318-32-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute / short-term exposure - systemic and local effects
Inhalation:
No relevant data are available that might indicate any systemic or local adverse effect after acute/short-term exposure to magnesium zirconium oxide. No systemic or local effects have been observed in the available short-term toxicological study with the read across substance zirconium dioxide, the main component in the crystal lattice of magnesium zirconium oxide, up to the maximal technically achievable concentration. Consequently, no DNELs needs to be derived.
However, occupational exposure limits for zirconium after short-term exposure have been set in various countries, the typical STEL (Short Term Exposure Limit, 15 minutes) being 10 mg Zr/m³ (some variation depending on the country under consideration). Therefore, although it is considered reasonable not to derive DNELs, the relevant exposure limit should be respected.
Dermal:
No relevant data are available that might indicate any systemic or local adverse effect after acute/short-term dermal exposure to magnesium zirconium oxide. Therefore no DNELs can be derived for this route of exposure.
Long-term exposure - systemic and local effects
Inhalation:
No data are available that might indicate any systemic or local adverse effect after long-term exposure to magnesium zirconium oxide. No systemic or local adverse effects have been observed in the available studies with zirconium dioxide, the main component in the crystal lattice of magnesium zirconium oxide. Therefore no long-term DNELs needs to be derived after inhalation exposure.
However, an 8-h Time Weighted Average (TWA) Occupational Exposure Limit (OEL) of 5 mg Zr/m³ has been defined in Europe by several national authorities as well as by NIOSH, ACGIH and OSHA in the USA. Therefore, although it is considered reasonable not to derive DNELs for magnesium zirconium oxide, the relevant exposure limit should be respected. Similarly, the occupational exposure limits set for magnesium oxide should be respected, however, since these are - depending on the country - typically 10 mg Mg/m3, the occupational exposure limit for zirconium (dioxide) will clearly be the most limiting.
Dermal:
No data are available that might indicate hazardous systemic or local effects after long-term dermal exposure. Therefore, no long-term DNELs are derived for this route of exposure.
Hazard for the eyes
Magnesium zirconium oxide was concluded not to be hazardous for eyes, based on information for zirconium dioxide (data used from yttrium zirconium oxide, considered relevant for zirconium dioxide) and magnesium oxide (data used from magnesium hydroxide, considered relevant for magnesium oxide).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Acute / short-term exposure - systemic and local effects
Inhalation:
No relevant data are available that might indicate any systemic or local adverse effect after acute/short-term exposure to magnesium zirconium oxide. No systemic or local effects have been observed in the available short-term toxicological study with the read across substance zirconium dioxide, the main component in the crystal lattice of magnesium zirconium oxide, up to the maximal technically achievable concentration. Consequently, no DNELs need to be derived.
Dermal:
No relevant data are available that might indicate any systemic or local adverse effect after acute/short-term dermal exposure to magnesium zirconium oxide. Therefore no DNELs can be derived for this route of exposure.
Oral:
Based on available experimental data, there are no acute toxic effects leading to classification, hence no acute/short-term DNEL (systemic effects) needs to be derived.
Long-term exposure - systemic and local effects
Inhalation:
Based on the available data and the same argumentation as for workers, no long-term DNELs need to be derived for the general population. In addition, no officially set values are available for the general population.
Dermal route:
Based on the same argumentation as for workers (no long-term dermal toxicity data available, no adverse effects observed in oral and inhalation repeated dose toxicity studies), no long-term DNELs need to be derived for the general population.
Oral:
No oral repeated dose toxicity studies are available for zirconium dioxide, however, read across can be performed from two studies with zirconium basic carbonate (another insoluble zirconium compound) and zirconium acetate (a 'water soluble' zirconium compound). In these studies, no adverse effects were observed up to the highest (limit) test dose. Therefore, it is not considered necessary to derive a long-term DNEL.
Further argumentation on read across and the overall extremely low potential of zirconium compounds for causing toxicity is given in the read across justification attached to Section 13 of IUCLID.
Hazards for the eyes
Magnesium zirconium oxide was concluded not to be hazardous for eyes, based on information for zirconium dioxide (data used from yttrium zirconium oxide, considered relevant for zirconium dioxide) and magnesium oxide (data used from magnesium hydroxide, considered relevant for magnesium oxide).
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