Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.6 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2.45 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.06 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
7.08 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
13.2 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.32 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.93 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Classification

The inorganic part of the molecule (lanthanum) is not biodegradable. Furthermore, the substance is not considered to be bioaccumulative based on bibliographic data in fish, the preferred species under REACH for assessing bioaccumulation potential. Short-term toxicity tests performed with fish and daphnids indicated that the substance is very toxic to fish and aquatic invertebrates. Acutely, aquatic invertebrates were considered as the most sensitive group of organisms. The key EC50 of 0.049 mg La/L (for Daphnia carinata) corresponds to 0.111 mg La(CH3COO)3/L.

Reliable long-term toxicity tests are available for dapnids and algae. For fish, the available prolonged toxicity test was considered reliable but not sufficient for covering the endpoint of long-term toxicity to fish. Therefore, this study was not considered for classification purposes. For selection of the key NOEC value however, the results from the algal growth inhibition test were also disregarded, because they were unavoidably blurred by the phosphate depletion effect in the test, which leads to an indirect inhibition of growth. Therefore, the NOEC of 0.03 mg La/L for Daphnia carinata was selected as key long-term effect concentration, corresponding to 0.068 mg La(CH3COO)3.

Taking into consideration the acute and long-term key effect concentration and in accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material is classified as:

Aquatic acute 1 (H400) - M-factor 1

Aquatic chronic 1 (H410) - M-factor 1

According to the Dangerous Substance Directive 67/548/EC (Annex VI, section 5.2.1.2), the substance should be classified as N; R50/53.