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 acute inhalation toxicity study is available for gadolinium oxalate. This route of exposure is considered not relevant for gadolinium oxalate because typically wet powders or dry powders with median particle size > 50 µm are manufactured. Further, since the toxicokinetics assessment concluded that absorption via inhalation can be expected to be extremely limited, no hazard is expected to be identified after acute inhalation exposure. Consequently, no DNELs need to be derived.

Dermal

No acute toxicity study for the dermal route is available for gadolinium oxalate, however, this study can be waived based on the recently added Column 2 adaptation of REACH An VIII, Section 8.5.3. According to this adaptation, the study can 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 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, performed with the read across substance gadolinium oxide (for further information reference can be made to the read across justification document attached to IUCLID section 13). Therefore it was not considered necessary to perform such study via the inhalation route of exposure.

Anyhow, low exposure to gadolinium oxalate is expected based on the inherent properties of this compound. No vapour pressure value has been determined as gadolinium oxalate does not melt below 300°C. Therefore, inhalation of gadolinium oxalate as a vapour is not likely to occur.

Further, gadolinium oxalate is typically manufactured as wet powder. Thus, the formation of respirable suspended particulate matter is unlikely. Occasionally manufactured dry powders typically have a D50 > 50 μm, which implies that no or only a very limited fraction of the powders may be respirable and capable of reaching the alveolar region of the lungs. Consequently, human exposure by inhalation is considered not significant for this compound.

Currently, no occupational exposure limits are set for inhalation exposure to gadolinium or gadolinium oxalate in the working environment. Since no obvious adverse effects were observed in the available OECD 422 read across 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, performed with the read across substance gadolinium oxide (for further information reference can be made to the read across justification document attached to IUCLID section 13). Therefore, it was not considered necessary to perform such study via the dermal route of exposure.

An in vivo skin sensitisation study performed with gadolinium oxalate 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 read across 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 studies, gadolinium oxalate 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 acute oral toxicity study with gadolinium oxalate up to the limit test dose, no DNELs need to be derived.

Inhalation

No acute inhalation toxicity study is available for gadolinium oxalate. This route of exposure is considered not relevant for gadolinium oxalate because typically wet powders or dry powders with median particle size > 50 µm are manufactured. Further, since the toxicokinetics assessment concluded that absorption via inhalation can be expected to be extremely limited, no hazard is expected to be identified after acute inhalation exposure. Consequently, no DNELs need to be derived.

Dermal

No acute toxicity study for the dermal route is available for gadolinium oxalate, however, this study can be waived based on the recently added Column 2 adaptation of REACH An VIII, Section 8.5.3. According to this adaptation, the study can 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 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 OECD 422 study by oral route performed with the read across substance gadolinium oxide (for further information reference can be made to the read across justification document attached to IUCLID section 13), 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, performed with the read across substance gadolinium oxide (for further information reference can be made to the read across justification document attached to IUCLID section 13). Therefore it was not considered necessary to perform such study via the inhalation route of exposure.

Anyhow, low exposure to gadolinium oxalate is expected based on the inherent properties of this compound. No vapour pressure value has been determined as gadolinium oxalate does not melt below 300°C. Therefore, inhalation of gadolinium oxalate as a vapour is not likely to occur.

Further, gadolinium oxalate is typically manufactured as wet powder. Thus, the formation of respirable suspended particulate matter is unlikely. Occasionally manufactured dry powders typically have a D50 > 50 μm, which implies that no or only a very limited fraction of the powders may be respirable and capable of reaching the alveolar region of the lungs. Consequently, human exposure by inhalation is considered not significant for this compound. Since no obvious adverse effects were observed in the available OECD 422 read across 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, performed with the read across substance gadolinium oxide (for further information reference can be made to the read across justification document attached to IUCLID section 13). Therefore, it was not considered necessary to perform such study via the dermal route of exposure.

An in vivo skin sensitisation study performed with gadolinium oxalate, 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 read across 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 studies, gadolinium oxalate is concluded not to be hazardous to eyes.