Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.245 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.036 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.025 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.35 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.862 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:
1.582 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

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 alkyl sulfates 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:

Biodegradation in water: readily biodegradable (OECD Guideline 301E)

Bioaccumulation: no potential to bioaccumulate; log Pow 1.69 – 1.9 at 20 ºC

Water solubility: > 500 g/L at 20 ºC (OECD 105)

 

Acute toxicity key values of C12-13AS Na (CAS 1231880-35-5):

- For fish: 96h LC50 (Oncorhynchus mykiss, mortality) = 3.6 mg/L (nominal concentration, OECD 203, read-across from CAS 85586-07-8)

- For invertebrates: 48h EC50 (Daphnia magna, mobility) = 4.7 mg/L (nominal concentration, OECD 202, read-across from CAS 85586-07-8)

- For algae: 72h EC50 (Desmodesmus subspicatus, growth rate) = 20 mg/L (nominal concentration, EU Method C.3, read-across from CAS 85586-07-8)

 

Chronic toxicity key values of C12-13AS Na (CAS 1231880-35-5):

- For fish: 42d NOEC (Pimephales promelas; mortality and growth) ≥ 1.357 mg/L (measured concentration, read-across from CAS 151-21-3)

- For invertebrates: 7d NOEC (Ceriodaphnia dubia, reproduction) = 0.391 mg/L (QSAR)

- For algae: 72h EC10 (Desmodesmus subspicatus, growth rate) = 5.4 mg/L (nominal concentration, EU Method C.3, read-across from CAS 85586-07-8)

- For microorganisms 3h EC50 (activated sludge respiration inhibition) = 135 mg/L (nominal concentration, similar to OECD 209, read-across from CAS 151-21-3)

- For mesocosm = 0.245 mg/L (normalized value)

 

Classification justification according to CLP:

Based on the available data, C12-13AS Na (CAS 1231880-35-5) 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 is 0.391 mg/L (thus in the rage of > 0.1 to < 1 mg/L) for aquatic invertebrates. C12-13AS Na (CAS 1231880-35-5) needs to be classified and labeled as environmental hazard Chronic Cat. 3 according to Regulation (EC) No.1272/2008 (CLP) and 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:

Based on the available data, C12-13AS Na (CAS 1231880-35-5) is considered to be rapidly degradable and has a low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 values are above 1 mg/L for fish, invertebrates and algae. C12-13AS Na (CAS 1231880-35-5) does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.