Registration Dossier

Diss Factsheets

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

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

- No acute data were available for the inhalation route of exposure. Data are available for both the oral and the dermal route of exposure. According to the REACH Regulation, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (column 2, annex VIII, section 8.5). Therefore, it is not necessary to perform an acute toxicity study via the inhalation route of exposure. In addition the substance appears as a clump and formation of respirable suspended particulate matter is unlikely.

- One acute dermal toxicity study has been performed: the LD50 is greater than 2000 mg/kg bw. Therefore, no DNEL for acute dermal exposure (systemic effects) has been derived. In the same study, no local effects were observed during the study. Therefore, no DNEL for acute dermal exposure (local effects) has been derived. 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.

- Lanthanum acetate is classified as severe eye irritant (R41) according to Directive 67/548/EEC and eye dam. 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 moderate hazard (i.e. '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). The No Observed Adverse Effect Level (NOAEL) for systemic toxicity after repeated dose was considered to be 1000 mg/kg bw/day in both males and females. Therefore, these effects could be considered as local effects rather than true systemic effects.

Thus, a worker-DNEL long-term for dermal route-systemic effects cannot be derived.

- Inhalation:

No long-term inhalation toxicity studies are available but an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening exits with lanthanum acetate (Braun, 2013). Since no systemic effects were seen in this study a worker-DNEL long-term for inhalation route-systemic effects cannot 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 reliable repeated dose toxicity study was available for this substance via the dermal and inhalation route of exposure. Although a repeated dose toxicity study is available, route-to-route extrapolation is not adequate for local effects. In addition, and due to the special properties of the substance, it appears as a clump and formation of respirable suspended particulate matter is unlikely. Furthermore the substance is not considered as skin corrosive/irritant. Therefore, a DNEL long-term exposure, local effects cannot be derived for the dermal and inhalation route of exposure.

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:
medium hazard (no threshold derived)

Additional information - General Population

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