Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 000 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.005 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:
7.5 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.

Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

Since the group concept is applied to the members of the AES category, data will be generated from a representative category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labeled on this basis.

 

Classification related key information for AES (C12 -14, 1-2.5EO) NH4 (CAS 125301 -88 -4):

Biodegradation in water: readily biodegradable (OECD 301B)

Bioaccumulation: no potential to bioaccumulate; log Pow <= -1.22 at 20 °C

Water solubility: > 310 g/L at 20 ºC (OECD 105)

 

Acute toxicity:

- For fish: 96 h LC50 (Danio rerio) = 7.1 mg a.i./L (nominal, OECD 203)

- For invertebrates: 48 h EC50 (Daphnia magna, immobilization) = 7.4 mg a.i./L (nominal, OECD 202)

- For algae: 72 h EC50 (Scenedesmus subspicatus, growth rate) = 14 mg a.i./L (nominal, OECD 201)

 

Chronic toxicity:

- For fish: 28 d NOEC (Oncorhynchus mykiss; mortality and sublethal effects) = 0.14 mg/L (measured, similar to OECD 215)

- For invertebrates: 21 d NOEC (Daphnia magna, reproduction): = 0.27 mg a.i./L (measured, OECD 211)

- For algae: 72h NOEC (Scenedesmus subspicatus, growth rate) = 0.95 mg a.i./L (measured, OECD 201)

 

Classification justification according to CLP of AES (C12 -14, 1-2.5EO) NH4 (CAS 125301 -88 -4):

Based on the data above, AES (C12 -14, 1-2.5EO) NH4 is considered to be rapidly degradable and has a low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 are above 1 mg/L for fish, invertebrates and algae. Valid chronic toxicity data are available to fish, invertebrates and algae – the lowest NOEC is 0.14 mg/L (thus in the range of > 0.1 to < 1 mg/L) for aquatic invertebrates. AES (C12 -14, 1-2.5EO) NH4 needs to be classified and labeled as environmental hazard Chronic Cat. 3 according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

M-factor for acute aquatic toxicity:  not need to be assigned

M-factor for chronic aquatic toxicity: not need to be assigned 

 

Classification justification according to DSD of AES (C12 -14, 1 -2.5EO) NH4 (CAS 125301 -88 -4):

Based on the data above, AES (C12 -14, 1-2.5EO) NH4 is considered to be rapidly degradable and have low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 values are above 1 mg/L for fish, invertebrates and algae. AES (C12 -14, 1-2.5EO) NH4 does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.