Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Acute / short-term exposure (systemic and local effects)

- No acute data were available for the inhalation route of exposure. In accordance with REACH Annex VIII, this study does not need to be conducted as exposure via inhalation is a less likely route of exposure than the dermal route due to the special properties of the test item. Indeed, the substance appears as a clump and formation of respirable suspended particulate matter is unlikely. Therefore, the second route of exposure for acute toxicity has been covered by the dermal exposure route.

- One acute dermal toxicity test has been performed: the LD50 is greater than 2000 mg/kg bw. Therefore, no DNEL acute dermal exposure (systemic effects) has been derived. Although no signs of systemic toxicity were observed in the acute dermal toxicity test mentioned above, one animal of 10 showed very slight erythema and slight desquamation. However this information is not sufficient to derive a DNEL, dermal route, acute/short term (local effects). Furthermore, although the substance is irritating to the eye (indicating irritating potential), the substance is not irritant to the skin according to CLP criteria. Therefore, no hazard needs to be addressed and no derivation of a DNEL is required.

- According to the criteria of the CLP Regulation, cerium trinitrate is classified as irritating to eyes (Cat 1, H318). 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.

Long-term exposure (systemic effects)

- Dermal: No long-term dermal toxicity studies are available but an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening (Braun, 2013) exits. In this study, the No Observed Adverse Effect Level (NOAEL) for systemic effects (parent animals) was considered to be 330 mg/kg bw/day. However this value can not be considered relevant for systemic toxicity after repeated oral exposure as this value was based on local effects rather than systemic effects: the morphological changes in the stomachs were reported to be local effects (irritation after repeated oral gavage) rather than systemic toxicity and the differences in the food consumption/body weight were considered secondary to the changes in the stomach. In addition, it is reported that two animals treated at 1000mg/kg bw/day died as a result of the stomach findings. Thus, no systemic effects related to the repeated oral exposure to the test item were really identified.

In the same study, some changes in some reproduction/developmental parameters were also observed at the highest dose of 1000 mg/kg bw/day and the NOEL for reproduction/developmental toxicity was considered to be 330 mg/kg bw/day. However, clear conclusion could not be drawn on this study regarding the possible causes of these changes: a secondary effect resulting from the chemical stress observed in males and pregnant females due to high local irritation observed in the stomach after repeated oral gavage of the compound or a primary effect of the substance). Therefore, these effects could be considered as local effects rather than true systemic effects.

Overall, as only local effects were observed, there are no adequate data for route-to-route extrapolation. Thus, a worker-DNEL long-term for dermal route-systemic effects can not be derived.

- Inhalation: No long-term inhalation toxicity studies are available for cerium trinitrate but an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening (Braun, 2013) exists. As described here above for the DNEL long-term for dermal route-systemic effects, these data are no adequate for route-to-route extrapolation. Therefore a worker-DNEL long-term for inhalation route-systemic effects can not be derived. Furthermore, and due to the special properties of the substance, it appears as a clump and formation of respirable suspended particulate matter is unlikely.

Long-term exposure (local effects)

- No repeated dose toxicity study was available for this substance via the dermal and inhalation route of exposure. Therefore, a DNEL long-term exposure, local effects cannot be derived for the dermal and inhalation route according to ECHA R8 guidance document, section R.8.1.2.6. Furthermore, and due to the special properties of the substance, it appears as a clump and formation of respirable suspended particulate matter is unlikely.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

No consumer use is expected. Therefore, no DNEL is derived.