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:
medium hazard (no threshold derived)

Additional information - workers

Short-term or long-term inhalation exposure - systemic and local effects

No reliable studies are available for acute or repeated dose toxicity via the inhalation route of exposure. For acute toxicity, no study was considered required because the dermal route of exposure was considered as the most relevant second route of exposure for testing. Indeed, because yttrium trinitrate is not expected to occur in the vapour phase, and is known to form clumps due to its hygroscopic behaviour, the inhalation route of exposure can be considered less relevant. For repeated dose toxicity, 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 relevant to perform such study via the inhalation route of exposure. Moreover, next to the fact that the inhalation route of exposure is considered less relevant (see above), it is clear from the toxicokinetics assessment that low bioavailability for uptake is expected when inhaled. Therefore, no hazard is expected to be identified after long-term exposure via inhalation. Since no systemic toxicity was observed in parent animals in the available OECD 422 study by oral route up to and including at the highest test dose and since the effects on live litter size, litter weight, mean pup weight and cumulative pup loss observed in the mid- and high-dose group were not or not clearly progressive with increasing dose, were not accompanied with other adverse effects such as in histopathology, and did not trigger classification for reproductive/developmental toxicity, the derivation of DNELs for long-term effects after inhalation exposure by extrapolation from the oral repeated dose toxicity study is not considered meaningful. It should be noted however that in most countries an occupational exposure limit of 1 mg Y/m3 is established for the working environment (8-h TWA, time-weighted average) which should be respected whatsoever.

Short-term or long-term dermal exposure - systemic and local effects

A reliable acute dermal toxicity study is available indicating that yttrium trinitrate does not present any local or systemic hazard after acute dermal exposure (LD50 > 2000 mg/kg). Moreover, other in vivo studies with dermal application, such as the in vivo skin irritation study and the in vivo skin sensitisation study, did not reveal any systemic effects either, and based on the results of the in vivo skin irritation study the substance does not need to be classified for local effects in skin under the CLP Regulation. Therefore, no acute DNELs for local or systemic effects after dermal exposure need to be derived. For repeated dose toxicity, 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 relevant to perform such study via the dermal route of exposure. Moreover, it is clear from the toxicokinetics assessment that extremely low bioavailability for uptake is expected after dermal exposure. Therefore, no hazard is expected to be identified after long-term dermal exposure. Since no systemic toxicity was observed in parent animals in the available OECD 422 study by oral route up to and including at the highest test dose and since the effects on live litter size, litter weight, mean pup weight and cumulative pup loss observed in the mid- and high-dose group were not or not clearly progressive with increasing dose, were not accompanied with other adverse effects such as in histopathology, and did not trigger classification for reproductive/developmental toxicity, the 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

Yttrium trinitrate is classified for Eye damage category 1 (H318) according to the CLP Regulation (EC) 1272/2008. According to ECHA's Guidance on Information Requirements and Chemical Safety Assessment, Part E, Table E.3-1 the substance should be considered to cause medium hazard.

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:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Short-term or long-term inhalation exposure - systemic and local effects

No reliable studies are available for acute or repeated dose toxicity via the inhalation route of exposure. For acute toxicity, no study was considered required because the dermal route of exposure was considered as the most relevant second route of exposure for testing. Indeed, because yttrium trinitrate is not expected to occur in the vapour phase, and is known to form clumps due to its hygroscopic behaviour, the inhalation route of exposure can be considered less relevant. For repeated dose toxicity, 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 relevant to perform such study via the inhalation route of exposure. Moreover, next to the fact that the inhalation route of exposure is considered less relevant (see above), it is clear from the toxicokinetics assessment that low bioavailability for uptake is expected when inhaled. Therefore, no hazard is expected to be identified after long-term exposure via inhalation. Since no systemic toxicity was observed in parent animals in the available OECD 422 study by oral route up to and including at the highest test dose and since the effects on live litter size, litter weight, mean pup weight and cumulative pup loss observed in the mid- and high-dose group were not or not clearly progressive with increasing dose, were not accompanied with other adverse effects such as in histopathology, and did not trigger classification for reproductive/developmental toxicity, the derivation of DNELs for long-term effects after inhalation exposure by extrapolation from the oral repeated dose toxicity study is not considered meaningful. Finally, it should be noted that currently only one use is identified which in theory may lead to exposure of consumers. However, the use under consideration is the service life of printed/coated articles, which is unlikely to result in inhalation exposure of consumers.

Short-term or long-term dermal exposure - systemic and local effects

A reliable acute dermal toxicity study is available indicating that yttrium trinitrate does not present any local or systemic hazard after acute dermal exposure (LD50 > 2000 mg/kg). Moreover, other in vivo studies with dermal application, such as the in vivo skin irritation study and the in vivo skin sensitisation study, did not reveal any systemic effects either, and based on the results of the in vivo skin irritation study the substance does not need to be classified for local effects in skin under the CLP Regulation. Therefore, no acute DNELs for local or systemic effects after dermal exposure need to be derived. For repeated dose toxicity, 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 relevant to perform such study via the dermal route of exposure. Moreover, it is clear from the toxicokinetics assessment that extremely low bioavailability for uptake is expected after dermal exposure. Therefore, no hazard is expected to be identified after long-term dermal exposure. Since no systemic toxicity was observed in parent animals in the available OECD 422 study by oral route up to and including at the highest test dose and since the effects on live litter size, litter weight, mean pup weight and cumulative pup loss observed in the mid- and high-dose group were not or not clearly progressive with increasing dose, were not accompanied with other adverse effects such as in histopathology, and did not trigger classification for reproductive/developmental toxicity, the derivation of DNELs for long-term effects after dermal exposure by extrapolation from the oral repeated dose toxicity study is not considered meaningful. Finally, it should be noted that currently only one use is identified which in theory may lead to exposure of consumers. However, the use under consideration is the service life of printed/coated articles, in which yttrium from yttrium trinitrate is incorporated into a solid matrix, which is unlikely to result in significant dermal exposure of consumers.

Short-term or long-term oral exposure - systemic and local effects

The key acute oral toxicity study performed with yttrium trinitrate triggers a classification for Acute Toxicity 4 under the CLP Regulation. The observed effects and mortality are however most likely the result of the irritant effects of the test item in the (fore)stomach of the animals, which were observed during post-mortem examination. Therefore yttrium trinitrate is considered to be of low hazard concerning short-term oral exposure. It was considered not necessary to derive a DNEL for the general population because the oral route of exposure, considering the identified uses of yttrium trinitrate, is not expected to be a relevant route of exposure for consumers, and because there is no clear evidence for the observed effects to be considered as systemic effects whereas local effects after oral exposure are normally not considered for the general population. For repeated dose toxicity after oral exposure, an OECD 422 study is available. Since no systemic toxicity was observed in parent animals up to and including at the highest test dose and since the effects on live litter size, litter weight, mean pup weight and cumulative pup loss observed in the mid- and high-dose group were not or not clearly progressive with increasing dose, were not accompanied with other adverse effects such as in histopathology, and did not trigger classification for reproductive/developmental toxicity, the derivation of DNELs is not considered meaningful. Moreover, as stated above, considering the identified uses of the substance, consumers are not expected to be significantly exposed via the use of printed/coated articles.

Hazards for the eyes

Yttrium trinitrate is classified for Eye damage category 1 (H318) according to the CLP Regulation (EC) 1272/2008. According to ECHA's Guidance on Information Requirements and Chemical Safety Assessment, Part E, Table E.3-1 the substance should be considered to cause medium hazard. Here too, it should be noted that ocular exposure is highly unlikely for the general population considering the identified uses of the substance.