Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.24 mg/L
Assessment factor:
5
PNEC freshwater (intermittent releases):
0.071 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.024 mg/L
Assessment factor:
50

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.092 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

Studies on aquatic organisms are available for alcohol C12 -14 ethoxysulfates or other members of the category alcohol ethoxysulfates. Nevertheless PNEC-calculation for surface water (freshwater and marine) as well as sediment (freshwater and marine) is based on a QSAR-model using chronic data available for freshwater invertebrates which is describe in detail before.

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) Na:

Biodegradation in water: readily biodegradable

Bioaccumulation: no potential to bioaccumulate; log Kow 0.3

Water solubility: 280 g/L at 20 ºC

 

Acute toxicity:

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

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

- For algae: 72 h ErC50 (Scenedesmus subspicatus, growth rate) = 27.7 mg a.i./L (OECD 201)

 

Chronic toxicity:

- For fish: 28 d LNOEC (Oncorhynchus mykiss) = 0.14 mg a.i./L (OECD 215)

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

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

 

Classification justification according to CLP:

Based on the available data alcohol C12-14 ethoxysulfates (CAS 68891-38-3) is considered to be rapidly degradable and has 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 values are 0.14 and 0.95 mg/L (thus in the rage of > 0.1 to < 1 mg/L) for aquatic invertebrates. Alcohol C12-14 ethoxysulfates (CAS 68891-38-3) 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 (4th ATP).

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

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