Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
5.49 µg/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:
2.06 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Reliable ecotoxicity data are available via read-across for 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts for acute fish toxicity, acute aquatic invertebrate toxicity, algal toxicity and chronic aquatic invertebrate toxicity. These studies showed a 96 h LC50 value of 2.12 mg/L for freshwater fish (Fathead Minnow), a 48 h EC50 value of 4 mg/L for Daphnia magna, a 72 h EC50 value of 2.26 mg/L and a 72 h NOEC value of 0.76 mg/L for marine algae (Skeletonema costatum), and a 21 d NOEC value of 1.05 mg/L for D. magna. A ready biodegradability study is available for 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts which demonstrated that the substance meets the criteria to be considered readily biodegradable.

 

The most conservative acute ecotoxicity data is the 96 h LC50 value of 2.12 mg/L from the acute fish toxicity study. Therefore, it is concluded that 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts is ‘Not classified’ for acute aquatic hazard classification under the CLP regulation (Regulation (EC) No 1272/2008), whereas under the Globally Harmonised System (GHS) the substance would be classified as Aquatic Acute Category 2 (H401: Toxic to aquatic life).

 

The most conservative chronic ecotoxicity endpoint is the 72 h NOEC value of 0.76 mg/L from the marine algal toxicity study. Given that the substance is concluded to be readily biodegradable, 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts is classified as Aquatic Chronic Category 3 (H412: Harmful to aquatic life with long lasting effects) under CLP and GHS.