Registration Dossier
Registration Dossier
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EC number: 234-373-8 | CAS number: 11129-15-0
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 effects
Inhalation:
No relevant data are available that might indicate any systemic adverse effect after acute/short-term exposure to calcium zirconium oxide. No systemic 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 calcium zirconium oxide, up to the maximal technically achievable concentration. Consequently, no DNEL needs to be derived.
However, an internationally recognized occupational exposure limit has been derived for zirconium compounds after short-term exposure: STEL (15 minutes) = 10 mg/m³. Therefore, although it is considered reasonable not to derive DNELs, this exposure limit should be respected where relevant.
Dermal:
No relevant data are available that might indicate any systemic adverse effect after acute/short-term dermal exposure to calcium zirconium oxide. Therefore no DNEL can be derived for this route of exposure.
Acute / short-term exposure - local effects
Inhalation:
No relevant data are available for calcium zirconium oxide that might indicate any local adverse effect after short-term exposure. Data available for the read across substance zirconium dioxide, the main component in the crystal lattice of calcium zirconium oxide, do not indicate any adverse local effects after acute/short-term inhalation exposure. Based on all this information, no DNEL 'local effects' is considered to be required for this route of exposure.
However, an internationally recognized occupational exposure limit has been derived for zirconium compounds after short-term exposure: STEL (15 minutes) = 10 mg/m3. Therefore, although it is considered reasonable not to derive DNELs, this exposure limit should be respected where relevant.
Dermal:
No relevant data are available that might indicate any local adverse effect after acute/short-term dermal exposure to calcium zirconium oxide. Therefore no DNEL 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 calcium 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 calcium zirconium oxide. Therefore no long-term DNEL needs to be derived after inhalation exposure.
However, an internationally recognised occupational exposure limit has been derived for zirconium compounds: OEL (8 h) = 5 mg/m³. Therefore, although it is considered reasonable not to derive DNELs for calcium zirconium oxide, this exposure limit should be respected where relevant. Similarly, it is recommended to respect the TWA of 1 mg/m3 for calcium oxide, which is the adopted from a Recommendation from the Scientific Committee on Occupational Exposure Limits (SCOEL) and is considered protective against adverse effects of calcium oxide in case of long-term exposure.
Dermal:
No data are available that might indicate hazardous systemic or local effects after long-term dermal exposure. Therefore, no long-term DNEL is derived for this route of exposure.
Hazard for the eyes
Calcium zirconium oxide is a stabilised zirconia, whereby zirconium dioxide and calcium oxide are incorporated in a single crystal lattice. The main component is zirconium dioxide (>= 90% w/w). Zirconium dioxide is not classified as hazardous to eyes. However, calcium oxide is classified as hazardous to eyes, more specifically as Eye damage Category 1 (H318).
When following – as a worst case – the mixture rules for classification of calcium zirconium oxide, and taking into account the fact that the current SIP supports calcium zirconium oxide with up to 10% w/w calcium oxide, this would result in classification as Eye damage Category 1 (H318) (total concentration of ingredients classified as Eye damage Category 1 ≥ 3%), with gradually less stringent classifications with decreasing % w/w calcium oxide. Even in case additivity would not apply, the substance should be classified as Eye damage Category 1 (concentration of an ingredient classified as Eye damage Category 1 ≥ 1%). However, the water solubility tests performed by Eidam (2014, 2015), in which the release of zirconium and calcium to the test medium (water) was quantified, indicated that maximally 0.0145% w/w calcium is released from calcium zirconium oxide (sample with 10% w/w calcium oxide). Assuming a hypothetical mixture of zirconium dioxide and calcium oxide in which all calcium oxide is dissolved in the aqueous medium, this would correspond to a mixture containing 0.02% w/w calcium oxide. Now, applying the generic cut-off values for substances in mixtures, calcium zirconium oxide should not be classified, as the % w/w calcium oxide is < 1%. Due to the limited release of calcium from calcium zirconium oxide, it is highly unlikely that a substantial pH increase and concurrent local effects would be observed in eyes due to dissolution of calcium (oxide). Therefore, the substance is considered as non-hazardous to eyes.
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 effects
Inhalation:
No relevant data are available that might indicate any systemic adverse effect after acute/short-term exposure to calcium zirconium oxide. No systemic 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 calcium zirconium oxide, up to the maximal technically achievable concentration. Consequently, no DNEL needs to be derived.
Dermal:
No relevant data are available that might indicate any systemic adverse effect after acute/short-term dermal exposure to calcium zirconium oxide. Therefore no DNEL 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.
Acute / short-term exposure - local effects
Inhalation:
No relevant data are available for calcium zirconium oxide that might indicate any local adverse effect after short-term exposure. Data available for the read across substance zirconium dioxide, the main component in the crystal lattice of calcium zirconium oxide, do not indicate any adverse local effects after acute/short-term inhalation exposure. Based on all this information, no DNEL 'local effects' is considered to be required for this route of exposure.
Dermal:
No relevant data are available that might indicate any local adverse effect after acute/short-term dermal exposure to calcium zirconium oxide. Therefore no DNEL can be derived for this route of exposure.
Long-term exposure - systemic effects
Inhalation:
No data are available that might indicate any systemic adverse effect after long-term exposure to calcium zirconium oxide. No systemic adverse effects have been observed in the available studies with zirconium dioxide, the main component in the crystal lattice of calcium zirconium oxide. Therefore no long-term DNEL needs to be derived after inhalation exposure.
Dermal route:
No data are available that might indicate hazardous systemic effects after long-term dermal exposure. Therefore, no long-term DNEL is derived for this route of exposure.
Oral:
The available data (read across from zirconium acetate and zirconium basic carbonate) do not indicate any hazardous systemic effects after long-term oral exposure. Therefore, no long-term DNEL is derived for this route of exposure.
Long-term exposure - local effects
Inhalation:
Based on the available data and the same argumentation as for workers, no long-term DNEL needs to be derived for the general population.
Dermal:
No data are available that might indicate hazardous local effects after long-term dermal exposure. Therefore, no long-term DNEL is derived for this route of exposure.
Hazard for the eyes
Calcium zirconium oxide is a stabilised zirconia, whereby zirconium dioxide and calcium oxide are incorporated in a single crystal lattice. The main component is zirconium dioxide (>= 90% w/w). Zirconium dioxide is not classified as hazardous to eyes. However, calcium oxide is classified as hazardous to eyes, more specifically as Eye damage Category 1 (H318).
When following – as a worst case – the mixture rules for classification of calcium zirconium oxide, and taking into account the fact that the current SIP supports calcium zirconium oxide with up to 10% w/w calcium oxide, this would result in classification as Eye damage Category 1 (H318) (total concentration of ingredients classified as Eye damage Category 1 ≥ 3%), with gradually less stringent classifications with decreasing % w/w calcium oxide. Even in case additivity would not apply, the substance should be classified as Eye damage Category 1 (concentration of an ingredient classified as Eye damage Category 1 ≥ 1%). However, the water solubility tests performed by Eidam (2014, 2015), in which the release of zirconium and calcium to the test medium (water) was quantified, indicated that maximally 0.0145% w/w calcium is released from calcium zirconium oxide (sample with 10% w/w calcium oxide). Assuming a hypothetical mixture of zirconium dioxide and calcium oxide in which all calcium oxide is dissolved in the aqueous medium, this would correspond to a mixture containing 0.02% w/w calcium oxide. Now, applying the generic cut-off values for substances in mixtures, calcium zirconium oxide should not be classified, as the % w/w calcium oxide is < 1%. Due to the limited release of calcium from calcium zirconium oxide, it is highly unlikely that a substantial pH increase and concurrent local effects would be observed in eyes due to dissolution of calcium (oxide). Therefore, the substance is considered as non-hazardous to eyes.
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