Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.675 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:
1.345 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 for C16-18 and C18 unsatd. AS Na (CAS 1394155-71-5):

Biodegradation in water: readily biodegradable (OECD 301 D)

Bioconcentration: no potential to bioaccumulate; log Pow = -0.69 at 20 ºC (OECD 107)

Water solubility: 46.61 g/L at 20 ºC (OECD 105)

 

Acute toxicity:

- For fish: 96h LC50 (Danio rerio) = 5.2 mg/L (nominal concentration, ISO 7346-1, read-across from CAS 68955-20-4)

- For invertebrates: 48h EC50 (Daphnia magna, immobilization) = 15 mg/L (nominal concentration, EU Method C.2, read-across from CAS 68955-19-1)

- For algae: 72h EC50 (Desmodesmus subspicatus, growth rate) = 34 mg/L (nominal concentration, DIN 38412, part 9, read-across from CAS 68955-20-4)

 

Chronic toxicity:

- For fish: 14d NOEC (Pimephales promelas, mortality and growth) = 1.65 mg/L (nominal concentration, OECD Guideline 204, read-across from CAS 68955-20-4)

- For invertebrates: 7d NOEC (Ceriodaphnia dubia, reproduction) = 0.204 mg/L (measured concentration, EPA-600/489/001, read-across from CAS 1120-01-1)

- For algae: 72h EC10 (Desmodesmus subspicatus, biomass) = 19 mg/L (nominal concentration, DIN 38412, part 9, read-across from CAS 68955-20-4)

 

Classification justification according to CLP:

Based on the data presented above, C16-18 and C18 unsatd. AS Na (CAS 1394155-71-5) 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 for fish, invertebrates and algae – the lowest NOEC is 0.204 mg/L (thus in a range > 0.1 to < 1 mg/L) for aquatic invertebrates. C16-18 and C18 unsatd. AS Na (CAS 1394155-71-5) 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:

Based on the data presented above, C16-18 and C18 unsatd. AS Na (CAS 1394155-71-5) 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. C16-18 and C18 unsatd. AS Na (CAS 1394155-71-5) does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.