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

As no local or systemic effects have been observed in the key acute inhalation toxicity study up to the maximal technically achievable concentration, no DNELs need to be derived.

Dermal

No acute toxicity study for the dermal route is available for ytterbium oxide, however, this study can be waived based on the Column 2 adaptation of REACH An VIII, Section 8.5 (acute toxicity data via oral route and one other route (inhalation) available). Moreover, based on the recently added Column 2 adaptation of REACH An VIII, Section 8.5.3, the study can also be waived if the substance does not meet the criteria for classification as STOT SE by oral route and in vivo studies with dermal application do not reveal any systemic effects. Based on the results of the (reliable) acute oral toxicity study and the in vivo skin sensitisation study these criteria for waiving are fulfilled. Further, since the toxicokinetics assessment concluded that absorption through the skin can be expected to be extremely limited, no hazard is expected to be identified after acute dermal exposure. Consequently, no DNELs need to be derived.

Long-term exposure - systemic and local effects

Inhalation

No reliable studies are available for repeated dose toxicity via the inhalation route of exposure. Only one route of exposure should be tested for repeated dose toxicity (Column 2 adaptation, REACH An VIII, Section 8.6.1), a requirement which is fulfilled by the availability of a reliable OECD 422 study by oral route. Therefore it was not considered necessary to perform such study via the inhalation route of exposure.

Moreover, the substance has a limited water solubility and therefore low bioavailability for uptake is expected when inhaled. Therefore, no hazard is expected to be identified after long-term exposure via inhalation. Currently, no occupational exposure limits are set for inhalation exposure to ytterbium or ytterbium oxide in the working environment. Since no obvious adverse effects were observed in the available OECD 422 study by oral route up to the highest test dose, derivation of DNELs for long-term effects after inhalation exposure by extrapolation from the oral repeated dose toxicity study is not considered meaningful.

Dermal

No reliable studies are available for repeated dose toxicity via the dermal route of exposure. Only one route of exposure should be tested for repeated dose toxicity (Column 2 adaptation, REACH An VIII, Section 8.6.1), a requirement which is fulfilled by the availability of a reliable OECD 422 study by oral route. Therefore, it was not considered necessary to perform such study via the dermal route of exposure.

An in vivo skin sensitisation study performed with ytterbium oxide did not yield any adverse local or systemic effects. Further, since the toxicokinetics assessment concluded that absorption through the skin can be expected to be extremely limited, no hazard is expected to be identified after long-term dermal exposure. Finally, since no obvious adverse effects were observed in the available OECD 422 study by oral route up to the highest test dose, derivation of DNELs for long-term effects after dermal exposure by extrapolation from the oral repeated dose toxicity study is not considered meaningful.

Hazards for the eyes

Based on the results of the available in vitro eye irritation study, ytterbium oxide is concluded not to be 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 and local effects

Oral

As no local or systemic effects have been observed in the (reliable) acute oral toxicity study up to the limit test dose, no DNELs need to be derived.

Inhalation

As no local or systemic effects have been observed in the key acute inhalation toxicity study up to the maximal technically achievable concentration, no DNELs need to be derived.

Dermal

No acute toxicity study for the dermal route is available for ytterbium oxide, however, this study can be waived based on the Column 2 adaptation of REACH An VIII, Section 8.5 (acute toxicity data via oral route and one other route (inhalation) available). Moreover, based on the recently added Column 2 adaptation of REACH An VIII, Section 8.5.3, the study can also be waived if the substance does not meet the criteria for classification as STOT SE by oral route and in vivo studies with dermal application do not reveal any systemic effects. Based on the results of the (reliable) acute oral toxicity study and the in vivo skin sensitisation study these criteria for waiving are fulfilled. Further, since the toxicokinetics assessment concluded that absorption through the skin can be expected to be extremely limited, no hazard is expected to be identified after acute dermal exposure. Consequently, no DNELs need to be derived.

Long-term exposure - systemic and local effects

Oral

As no obvious adverse effects have been observed in the key OECD 422 study by oral route, no DNELs need to be derived.

Inhalation

No reliable studies are available for repeated dose toxicity via the inhalation route of exposure. Only one route of exposure should be tested for repeated dose toxicity (Column 2 adaptation, REACH An VIII, Section 8.6.1), a requirement which is fulfilled by the availability of a reliable OECD 422 study by oral route. Therefore it was not considered necessary to perform such study via the inhalation route of exposure.

Moreover, the substance has a limited water solubility and therefore low bioavailability for uptake is expected when inhaled. Therefore, no hazard is expected to be identified after long-term exposure via inhalation. Since no obvious adverse effects were observed in the available OECD 422 study by oral route up to the highest test dose, derivation of DNELs for long-term effects after inhalation exposure by extrapolation from the oral repeated dose toxicity study is not considered meaningful.

Dermal

No reliable studies are available for repeated dose toxicity via the dermal route of exposure. Only one route of exposure should be tested for repeated dose toxicity (Column 2 adaptation, REACH An VIII, Section 8.6.1), a requirement which is fulfilled by the availability of a reliable OECD 422 study by oral route. Therefore, it was not considered necessary to perform such study via the dermal route of exposure.

An in vivo skin sensitisation study performed with ytterbium oxide did not yield any adverse local or systemic effects. Further, since the toxicokinetics assessment concluded that absorption through the skin can be expected to be extremely limited, no hazard is expected to be identified after long-term dermal exposure. Finally, since no obvious adverse effects were observed in the available OECD 422 study by oral route up to the highest test dose, derivation of DNELs for long-term effects after dermal exposure by extrapolation from the oral repeated dose toxicity study is not considered meaningful.

Hazards for the eyes

Based on the results of the available in vitro eye irritation study, ytterbium oxide is concluded not to be hazardous to eyes.