Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.007 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.01 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:
6.8 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.099 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:
0.195 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 301D)

Bioaccumulation: no potential to bioaccumulate; logPow = 2.9 at 20 ºC (OECD 107)

Water solubility: 10.73 g/L at 20 ºC (EU method A.6)

 

 Acute toxicity key values for C14-16AS Na (CAS 91648-54-3):

- For fish: 96h LC50 (Oncorhynchus mykiss, mortality) = 0.976 mg/L (nominal, OECD 203)

- For invertebrates: 48h LC50 (Daphnia magna, mobility) = 3.305 mg/L (measured, OECD 202)

 - For algae: 72h EC50 (Pseudokirchneriella subcapitata, growth rate) = 4.43 mg/L (nominal concentration, EPA OPPTS 850.5400, read-across from C14-15AS Na)

 

Chronic toxicity key values for C14-16AS Na (CAS 91648-54-3):

- For fish: 34d NOEC (Pimephales promelas; mortality and growth) = 0.11 mg/L (measured concentration, read-across from C14-15AS Na)

 - For invertebrates: 7d NOEC (Ceriodaphnia dubia, reproduction) = 0.072 mg/L (measured concentration, EPA-600/489/001; read-across from CAS 1191-50-0 and CAS 1120-01-0)

 - For algae: 72h EC10 (Pseudokirchneriella subcapitata, growth rate) = 1.38 mg/L (nominal concentration, EPA OPPTS 850.5400, read-across from C14-15AS Na)

 

Classification justification according to CLP:

Based on the data above, C14-16AS Na (CAS 91648-54-3) is considered to be rapidly degradable and has a low potential for bioaccumulation. The acute toxicity L(E)C50 is below 1 mg/L for aquatic invertebrates. Valid chronic toxicity data are available for all trophic levels. The lowest NOEC values are in a range > 0.01 to < 0.1 mg/L for aquatic invertebrates. C14-16AS Na (CAS 91648-54-3) therefore needs to be classified and labeled as environmental hazard Acute 1 and Chronic Cat. 2 according to Regulation (EC) No.1272/2008 (CLP) and Regulation (EU) No. 286/2011 (2nd ATP).

M-factor for acute aquatic toxicity:  1

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