Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
45.5 ng/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
455 ng/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
4.55 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
45.5 ng/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
15.8 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:
934 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC aqua (freshwater), PNEC aqua (marine), PNEC aqua (intermittent release)

Three acute studies with freshwater fish, invertebrates and algae are available for C16 Alkylamidopropyltrimethylammonium Chloride, but no long-term or reproduction study, nor studies with marine organisms. Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied and the PNEC aqua (freshwater) was derived from the 96 h LC50 value of 45.5 µg/L, determined with embryonic stages of Danio rerio, the most sensitive of the organisms tested. This results in a PNECaqua (freshwater) of 45.5 ng/L.

 

An assessment factor of 10000 was applied and the PNEC aqua (marine) was derived from the 96 h LC50 value of 45.5 µg/L, determined with embryonic stages of Danio rerio. This results in a PNECaqua (marine) of 4.55 ng/L.

 

An assessment factor of 100 was applied to the lowest L(E)C50, which was the 96 h LC50 = 45.5 µg/L, determined with embryonic stages of Danio rerio. Thus, the PNECaqua(Intermittent release) was calculated to be 455 ng/L.

 

PNEC STP

The PNEC STP was based on the 14 d NOEC of 2000 mg/L obtained in a Ready Biodegradability - Manometric Respirometry Test. Based on the available data, an assessment factor of 10 was applied in accordance with the Guidance in Information requirements and chemical safety assessment, R.10, to calculate the PNEC STP = 200 mg/L.

 

PNEC air

The registration substance has a low vapour pressure of 2.7E-07 Pa at 20°C. Based on this no risk for air breathing animals and humans is expected.

 

PNECoral (secondary poisoning)

Bioaccumulation potential has been estimated to be low. There is no concern for secondary poisoning and therefore no PNECoral (secondary poisoning) was derived.

 

PNEC sediment(freshwater), PNEC sediment (marine waters), PNEC soil

No toxicity tests with sediment dwelling or terrestrial organisms are available. Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, the PNEC for freshwater and marine water sediment as well as the PNEC soil have been calculated with the equilibrium partitioning method using EUSES 2.1.

 

The following data have been taken into account for calculation: 

Molecular weight

291.07 g/mol

Melting point

89°C

Vapour pressure

2.7E-07 Pa at 20°C

(Set to minimum value of 1E-06 in EUSES)

Water solubility

203 mg/L at 20.1!C

Log Kow

2.49

PNEC Aqua(freshwater)

45.5 ng/L

PNEC Aqua(marine water)

4.55 ng/L

Kd

915.22 L/kg

Kp (soil-water)

1372.83 L/kg

Kp (sediment-water)

457.61 L/kg

Kp (suspended matter-water)

228.8 L/kg

Kp (solids-water in raw sewage sludge)

27.5 L/kg

Kp (solids-water in settled sewage sludge)

27.5 L/kg

Kp (solids-water in activated sewage sludge)

27.5 L/kg

Kp (solids-water in effluent sewage sludge)

27.5 L/kg

The calculation resulted in a PNEC sediment(freshwater) of 158 µg/kg sediment dw, a PNEC sediment (marine waters) of 15.8 µg/kg sediment dw and a PNEC soil of 934 µg/kg soil dw.

Conclusion on classification

The most sensitive organism to C16 Alkylamidopropyltrimethylammonium Chloride was Danio rerio. Thus, the lowest acute toxicity value is the 96 h LC50 to embryonic stages of Danio rerio of 45.5 µg/L. This value was used for the calculation of PNECs. Chronic toxicity data are available for algae only (ErC10 = 0.205 mg/L).

In accordance with Regulation EC No 1272/2008, based on these results and the substance being rapidly biodegradable, C16 Alkylamidopropyltrimethylammonium Chloride has to be classified as Aquatic Acute 1 with an M factor of 10 and Aquatic Chronic 3.