Registration Dossier

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 tungsten 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 tungsten zirconium oxide, up to the maximal technically achievable concentration. Consequently, no DNELs needs to be derived.

However, national occupational exposure limits for zirconium and tungsten compounds should be respected where relevant. The STEL (Short Term Exposure Limit, 15 minutes) for both zirconium and tungsten is typically 10 mg/m³.

Dermal:

No relevant data are available that might indicate any systemic or local adverse effect after acute/short-term dermal exposure to tungsten zirconium oxide. Therefore, no DNELs are 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 tungsten 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 tungsten zirconium oxide. Therefore no long-term DNELs needs to be derived after inhalation exposure.

However, national occupational exposure limits for zirconium and tungsten compounds should be respected where relevant. The 8-h Time Weighted Average (TWA) Occupational Exposure Limit (OEL) for both zirconium and tungsten is typically 5 mg/m³. Therefore, although it is considered reasonable not to derive DNELs for tungsten zirconium oxide, this exposure limit should be respected where relevant.

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

Tungsten zirconium oxide was found not to to be an eye irritant (in vitro testing).

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 tungsten 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 tungsten 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 tungsten 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.

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

Tungsten zirconium oxide was concluded not to be hazardous for eyes.