Registration Dossier
Registration Dossier
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EC number: 264-885-7 | CAS number: 64417-98-7
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 yttrium 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 of yttrium zirconium oxide, up to the maximal technically achievable concentration. Consequently, no DNEL needs to be derived.
However, occupational exposure limits, internationally recognised, have been derived for zirconium and yttrium after short-term exposure: STEL (15 minutes) = 10 mg Zr/m3 and 2-10 mg Y/m3 (depending on the country). Therefore, although it is considered reasonable not to derive DNELs, these exposure limits 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 yttrium zirconium oxide. However, since the oral LD50 was consistently > 2000 mg/kg bw in the three available studies, and since no systemic effects have been observed in the available in vivo studies with dermal exposure (i.e. the in vivo skin irritation and skin sensitisation studies), yttrium zirconium oxide can be concluded not to be classified for acute toxicity after dermal exposure. Therefore no DNEL needs to be derived for this route of exposure either.
Acute / short-term exposure - local effects
Inhalation
No relevant data are available for yttrium 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 of yttrium 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, occupational exposure limits, internationally recognised, have been derived for zirconium and yttrium after short-term exposure: STEL (15 minutes) = 10 mg Zr/m3 and 2-10 mg Y/m3 (depending on the country). Therefore, although it is considered reasonable not to derive DNELs, these exposure limits should be respected where relevant.
Dermal
The available in vivo studies with dermal exposure (i.e. the in vivo skin irritation and skin sensitisation studies) did not indicate any local adverse effects after acute/short-term dermal exposure to yttrium zirconium oxide. Therefore no DNEL needs to be derived for this route of exposure.
Long-term exposure - systemic and local effects
Inhalation
No data are available that might indicate any systemic adverse effect after long-term exposure to yttrium zirconium oxide. No systemic adverse effects have been observed in the available studies with zirconium dioxide, the main component of yttrium zirconium oxide. Therefore no long-term DNEL needs to be derived after inhalation exposure.
However, occupational exposure limits, internationally recognised, have been derived for zirconium and yttrium after long-term exposure: OEL (8 h) = 5 mg Zr/m3 and TWA (8 h) = 1 mg Y/m3. Therefore, although it is considered reasonable not to derive DNELs for yttrium zirconium oxide, these exposure limits should be respected where relevant.
Dermal
There are no relevant data available that might indicate hazardous systemic or local effects after long-term dermal exposure. Therefore, no long-term DNEL can be derived for this route of exposure.
Hazard for eyes
The available in vivo eye irritation study with yttrium zirconium oxide did not result in classification for eye damage or irritation. Therefore no hazard assessment should be performed.
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 yttrium 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 of yttrium 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 yttrium zirconium oxide. However, since the oral LD50 was consistently > 2000 mg/kg bw in the three available studies, and since no systemic effects have been observed in the available in vivo studies with dermal exposure (i.e. the in vivo skin irritation and skin sensitisation studies), yttrium zirconium oxide can be concluded not to be classified for acute toxicity after dermal exposure. Therefore no DNEL needs to be derived for this route of exposure either.
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 yttrium 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 of yttrium zirconium oxide, do not indicate any adverse local effect 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
The available in vivo studies with dermal exposure (i.e. the in vivo skin irritation and skin sensitisation studies) did not indicate any local adverse effects after acute/short-term dermal exposure to yttrium zirconium oxide. Therefore no DNEL needs to 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 yttrium zirconium oxide. No systemic adverse effects have been observed in the available studies with zirconium dioxide, the main component of yttrium zirconium oxide. Therefore no long-term DNEL needs to be derived after inhalation exposure.
Dermal
There are no relevant data available that might indicate hazardous systemic or local effects after long-term dermal exposure. Therefore, no long-term DNEL can be 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 exposure 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 can be derived for this route of exposure.
Hazard for eyes
The available in vivo eye irritation study with yttrium zirconium oxide did not result in classification for eye damage or irritation. Therefore no hazard assessment should be performed.
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