Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.021 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.211 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.076 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.003 mg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Since the substance is classified as chronic Cat. 3 for the environment, an assessment of the potential hazard of Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate to aquatic, sediment dwelling and terrestrial species was performed. The environmental exposure assessment (see CSR attached to IUCLID section 13) shows that the Risk Characterization Ratio (i. e. PEC/PNEC ratio) in the aquatic, sediment and soil compartment is < 1 and therefore, under the current exposure conditions, Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate does not pose a risk to the environment.

Conclusion on classification

Conclusion on Classification

Biodegradation: 99 % after 28 d (OECD 301C, organic moiety)

Bioaccumulation: BCF < 23 (Cyprinus carpio, OECD 305, nominal)

 

Aquatic acute toxicity

Fish: 96 h, LC50 (Oncorhynchus mykiss): > 100 mg/L (nominal; OECD 203)

Aquatic invertebrates: 48 h, EC50 (Daphnia magna): > 34 mg/L (measured; OECD 202)

Aquatic algae: 72 h, EC50 (P. subcapitata): 21.1 mg/L (measured; OECD 201)

 

Aquatic chronic toxicity

Fish: no data

Aquatic invertebrates: no data

Aquatic algae: 72 h, NOEC (P. subcapitata): 0.352 mg/L (measured; OECD 201)

 

Classification according to CLP

Based on the data above, Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate needs to be classified and labelled as environmental hazard Chronic Cat. 3 according to Regulation (EC) No. 1272/2008 (CLP) and further amendments based on the NOErC (72h) of 0.352 mg/L for algae.

M-factor for acute aquatic toxicity: -

M-factor for chronic aquatic toxicity: -