Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
108.44 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
123 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

In general, the calculation of a DNEL is based on the observed effect level which has to be modified as described in “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, May 2008).

The assessment factors applied were chosen on the basis of a recent publication by Eurometaux which is attached to this dossier.

 

For calculation of the DNEL for long-term inhalative systemic effects, an allometric scaling has to be applied to take into account route-to-route extrapolation as well as the interspecies difference between rat and human. Therefore, the no observed effect level has to be corrected by 1/0.38 and 6.7/10 regarding respiratory volume and frequency. Thus, the corrected starting point for workers was 650.61 mg/m3/d for inhalation exposure.

Subsequently, the assessment factors are listed, which have to be taken into account for the calculation of the inhalation DNEL: intraspecies differences (3), exposure duration (2).

Thus, the resulting DNEL for long-term inhalative systemic effects of Lanthanum chloride, anhydrous is 108.44 mg/m3for workers.

For the derivation of the sytemic dermal DNEL a correction of the starting point is not required.

Subsequently, following assessment factors are taken into account for the DNEL calculation: intraspecies differences (3), exposure duration (2).

As a consequence, the resulting DNEL for long-term dermal systemic effects of Lanthanum chloride is 123 mg/kg bw/d for workers.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Lanthanum chloride is used in industrial settings only. The substance is used as an intermediate in catalysts in industrial settings only. In some instances substance or a derivative will be incorporated into the matrix of the catalyst produced. The substance wil not be part of the final product of the catalysed reaction. Therefore, DNELs for consumers or the general population are not relevant.