Registration Dossier

Diss Factsheets

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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