Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.045 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
526 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.027 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:
0.02 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

This substance is a member of the category of "Palladium & inorganic Palladium substances". As such,

the data requirements for this substance are covered by relevant and reliable experimental test data generated for all members of this category via a read-across approach.

A read-across justification report and PNEC derivation report are attached in IUCLID Annex 13.

Conclusion on classification

Environmental classification for the soluble metal substances under consideration is based on the lowest acute and chronic threshold values from the Pd ecotoxicity test data:

-chronic ERV: lowest chronic threshold value is 2.26 µg Pd/L (geometric mean EC10 value (growth rate) with P. subcapitata, based on the experimental results for diamminedichloropalladium (EC10 = 1.88 µg Pd/L; Wenzel 2012) and tetraamminepalladium dichloride (EC10=2.72 µg Pd/L; Wenzel 2018))

-acute ERV: lowest acute threshold value is 3.57 µg Pd/L (geometric mean EC50 value (growth rate) with P. subcapitata, based on the experimental results for diamminedichloropalladium (EC50=2.96 µ Pd/L; Wenzel 2012) and tetraamminepalladium dichloride (EC50 = 4.31 µg Pd/L; Wenzel 2018)).

The derivation of both ERV values is detailed in the read-across justification report (cfr. IUCLID Section 13) and PNEC derivation report (cfr. IUCLID Section 13).

For classification purposes, these ERVs have been recalculated to the values expressed as the concentration of the substance (conversion based on molecular weight conversion from soluble ion to the substance considered – cfr. details in below table). This results in a classification as Acute Category 1 and Chronic Category 1 for all substances contained in the below table. Acute and chronic M-factors are based on the value of the substance-specific acute and chronic ERV, as outlined in ECHA Guidance on the application of the CLP criteria (version 5.0; ECHA, 2017) - cfr. below table.

 

Substance name Molecular formula MWt Pd Wt% Acute ERV
(µg TI/L)
Chronic ERV
(µg TI/L)
Acute aquatic hazard Acute
M-factor
Long-term aquatic hazard Chronic
M-factor
Palladium dichloride PdCl2 177.3 60.0 5.9 3.8 category Acute 1 M=100 category Chronic 1 M=10 
Dihydrogen tetrachloropalladate Cl4Pd.2H 250.2 42.5 8.4 5.3 category Acute 1 M=100 category Chronic 1 M=10 
Palladium sulphate PdSO4 202.5 52.6 6.8 4.3 category Acute 1 M=100 category Chronic 1 M=10 
Disodium tetrachloropalladate   Na2PdCl4 294.2 36.2 9.9 6.2 category Acute 1 M=100 category Chronic 1 M=10 
Diamminedichloropalladium Cl2H6N2Pd 211.4 50.3 7.1 4.5 category Acute 1 M=100 category Chronic 1 M=10 
Tetraamminepalladium (II) nitrate H12N4Pd(NO3)2 298.6 35.6 10.0 6.3 category Acute 1 M=10  category Chronic 1 M=10 
Tetraamminepalladium(2+) dichloride H8Cl2N4Pd 241.4 44.1 8.1 5.1 category Acute 1 M=100 category Chronic 1 M=10 
Tetraamminepalladium(2+) dihydroxide H12N4Pd(OH)2 208.6 51.0 7.0 4.4 category Acute 1 M=100 category Chronic 1 M=10 
Tetramminepalladium(2+) diacetate C4H22N4O6Pd 328.7 32.4 11.0 7.0 category Acute 1 M=10  category Chronic 1 M=10 
Dipotassium hexachloropalladate K2PdCl6 397.3 26.8 13.3 8.4 category Acute 1 M=10  category Chronic 1 M=10 
Diammonium hexachloropalladate (NH4)2PdCl6 355.2 30.0 11.9 7.5 category Acute 1 M=10  category Chronic 1 M=10 
Tetraamminepalladium(2+) hydrogencarbonate  C2H14O6.N4Pd  296.6 35.9 9.9 6.3 category Acute 1 M=100 category Chronic 1 M=10 
Pd acetate Pd.(C2H3O2)2 224.5 47 7.5 4.8 category Acute 1 M=100 category Chronic 1 M=10