Poly(oxy-1,2-ethanediyl), .alpha.-[3-[(carboxymethyl)methylamino]-2-hydroxypropyl]-.omega.-(4-nonylphenoxy)-, sodium salt (1:1)

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

3.9 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

39.2 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.4 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

5.74 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.138 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.014 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:

25.3 µg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

The aquatic ecotoxicity database for nonylphenol ethoxylate, sarcosine derivative (CAS number 75627-31-5) is limited to an acute toxicity study with Daphnia magna, an algae toxicity study with Desmodesmus subspicatus and a micro-organisms respiration inhibition study with sewage sludge. Read-across has been used to assess the toxicity to fish and as supporting information for the toxicity to Daphnia.

The acute toxicity data reported for the read-across substance indicate that fish (96h-LC50 = 1.3 mg/L) and Daphnia (48h-LC50 = 1.8 mg/L) are equally sensitive to the substance. The same can be concluded with respect to long term effects for fish (28d-NOEC = 0.1 mg/L) and Daphnia (21d-NOEC = 0.18 mg/L).

The comparison between the effects of the registered substance and the read-across substance reveals that effects of the registered substance (48h-EC50 Daphnia = 3.92 mg /L) occur in the same range as for the read-across substance (48h-EC50 Daphnia = 1.8 mg/L).

Overall it can be concluded that fish and Daphnia are equally sensitive, whereas algea appear less sensitive compared to fish and Daphnia. It can also be concluded that the toxicity of the registered substance is in the same range as the toxicity of the read-across substance. As the toxicity of both substances lies in the same range, it has been preferred to derive the PNEC on the basis of the fully reliable 48h-EC50 Daphnia of 3.92 mg/L determined for the registered substance itself. This figure is based on measured test concentrations and is converted to the active ingredient content. 

The hazard assessment for the aquatic compartment is based on the following data:

	Result	Remarks	Reference
Oncorhynchus mykiss OECD 203	96h-LC50 = 1.3 mg/L	Read-across, Reliability 2, Nominal conc.	Wetton, 1996
Oncorhynchus mykiss OECD215	28d-NOEC = 0.1 mg ai/L 28d-LOEC = 0.18 mg ai/L	Read-across, Reliability 2 Nominal conc.	Wetton, 1992
Daphnia magna OECD 202	48h-EC50 = 3.92 mg ai/L*	Reliability 1 Measured concentration	Noack, 2013
Daphnia magna OECD 202	48h-LC50 = 1.8 mg ai/L	Read-across Reliability 2 Nominal conc.	Wetton, 1996
Daphnia magna 21d OECD 202 (1984)	21d-NOEC = 0.18 mg ai/L	Read-across Reliability 2 Nominal conc.	Wetton, 1999
Desmodesmus subspicatus OECD 201	72h-ErC50 > 10.2 mg ai/L 72h-ErC10 = 5.13 mg ai/L	Reliability 1 Measured concentration	Scheerbaum, 2012
Microorganisms OECD 209	3h-EC50 = 421 mg ai/L 3h-EC10 =57.4 mg ai/L	Reliability 1 Nominal conc.	Fiebig, 2012

^{*Figure in bold is used for PNEC derivation}

Conclusion on classification

For classification purposes Ecotoxicity, Biodegradability and Bioconcentration have to be considered.

Ecotoxicity

The classification is based on the following aquatic toxicity data:

Fish short term Oncorhynchus mykiss OECD 203	96h-LC50 = 1.3 mg/L	Read-across Reliability 2 (Wetton, 1996)
Fish chronic Oncorhynchus mykiss OECD215	28d-NOEC = 0.1 mg ai/L 28d-LOEC = 0.18 mg ai/L	Read-across Reliability 2 (Wetton, 1992)
Crustaceae short term Daphnia magna OECD 202	48h-EC50 = 3.92 mg ai/L	Reliability 1 (Noack, 2013)
Crustaceae short term Daphnia magna OECD 202	48h-EC50 = 1.8 mg ai/L	Read-across Reliability 2 (Wetton, 1996)
Crustaceae chronic Daphnia magna 21d OECD 202 (1984)	21d-NOEC = 0.18 mg ai/L	Read-across Reliability 2 (Wetton, 1999)
Algae short term/chronic Desmodesmus subspicatus OECD 201	72h-ErC50 = > 10.2 mg ai/L 72h-ErC10 = 5.13 mg ai/L	Reliability 1 (Scheerbaum, 2012)

Biodegradability

The substance is not readily biodegradable and considered stable to hydrolysis under environmental conditions. Therefore the substance is considered to be not rapidly degradable for classification purposes.

Bioaccumulation potential

The log Kow is determined as 3.9 and the calculated BCF amounts 412 L/kg. It can be concluded that these values are close to (but below) the criteria that indicate a potential to bioaccumulate (criteria: log Kow > 4 and BCF > 500).

Conclusion classification according to Regulation (EC) 1272/2008 (CLP)

Acute toxicity data are available for fish (read-across), daphnia and algae. As all acute toxicity values exceed 1 mg/L, the substance is not classified for acute aquatic hazards.

Chronic toxicity data are available only for fish (read-across), Daphnia (read-across) and algae. As algae cannot be designated as the most sensitive species on the basis of the available acute toxicity data, the classification is based on the data that provide the most strict classification. Based on the fully reliable acute toxicity data for the registered substance in combination with information on the substance being not rapid biodegradable, the substance is classified with:

Aquatic hazard Category Chronic 2

M-factor need not be determined as the substance is not classified with Acute Category 1 or Chronic Category 1.

Classification according to 67/548/EEC (DSD)

The lowest acute EC50 values are between 1 – 10 mg/L. As the substance is not readily biodegradable and stable to hydrolysis, the substance is considered not rapidly biodegradable. Therefor the substance is classified with:

N; R51/53