Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

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:
1.5 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.15 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:
0.224 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 Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt:

Biodegradation in water: 100% after 28 days (OECD 301 B)

Bioconcentration: low potential to bioaccumulate; log Pow = 1.0

Water solubility: > 500 g/L

 

Acute toxicity key values for Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt:

48hr LC50 (Cyprinus carpio pre-larvae, mortality) = 13 mg/L (nominal concentration, Japanese Industrial Standard JIS K0102; read across from CAS 142-87-0)

- For invertebrates: 48h EC50 (Daphnia magna, immobilization) > 100 mg/L (WoE, read across from CAS 126-92-1 and CAS 142-87-0)

- For algae: 7 72h EC50 (Pseudokirchneriella subcapitata, growth rate) = 8.64 mg/L (measured concentration, OECD 201; read across from CAS 142-87-0)

 

Chronic toxicity key values for Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt:

42d NOEC (Pimephales promelas; mortality and growth) >= 1.357 mg/L (measured concentration; read-across from CAS 151-21-3)

- For invertebrates: 21d NOEC (Daphnia magna, reproduction) = 1.4 mg/L (measured concentration, OECD 211, read-across from CAS 142-87-0)

- For algae: 72h EC10 (Pseudokirchneriella subcapitata, growth rate) = 0.95 mg/L (measured concentration, OECD 201; read across from CAS 142-87-0)

 

Classification justification according to CLP:

Based on the data above, Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt 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 0.95 mg/L (thus in a range > 0.1 to < 1 mg/L) for aquatic algae. Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt needs to be classified and labeled as environmental hazard Chronic Cat. 3 according to Regulation (EC) No.1272/2008 (CLP) and further amendments (ATPs).

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

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