Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.051 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.64 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.005 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.164 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.054 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:
0.077 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Acute and chronic aquatic toxicity test results are used in the risk assessment. Aquatic toxicity against aquatic invertebrates, fish and algae is addressed by experimental results. Chronic values are available for Daphnia and algae. As Daphnia magna was the most sensitive organism in acute toxicity tests a long-term study according to OECD 211 and GLP was conducted (Noack 2004). Within this study the lowest effect concentration was determined with a 21-d NOEC of 0.51 mg/L.

Conclusion on classification

In acute aquatic toxicity tests the effect concentrations were above 1 mg/L (lowest acute EC50 is a 48-h EC50 (D. magna) of 164 mg/L). No acute classification is needed.

In a weight of evidence approach (3-chloro-2-hydroxypropyl)trimethylammonium chloride (CHPTAC) was rated as not readily biodegradable. In chronic aquatic toxicity tests, the test item revealed NOEC values ≤ 1 mg/L and ≥ 0.1 mg/L, and thus needs to be classified as hazardous to the aquatic environment in accordance with Section 4.1.2.6., Annex I of Regulation 1272/2008/EC. As the test item is not considered readily biodegradable, the relevant classification is Aquatic Chronic 2 (H411).