Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.022 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.015 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:
6.8 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.024 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:
0.123 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 301 D)

Bioaccumulation: no potential; log Pow ≤ -0.62 at 20 ºC (OECD 107)

Water solubility: > 450 g/L at 20 ºC (OECD 105)

 

Acute toxicity key values of C8-18AS Mg & TEA (CAS 85586-38-5):

- For fish: 96h LC50 (mortality) = 10.5 mg/L (read-across from CAS 142-31-4, CAS 142-87-0, CAS 151-21-3, CAS 1191-50-0 and CAS 68955-20-4)

- For invertebrates: 48h EC50 (Daphnia magna, immobilization) = 1.5 mg/L (read-across from CAS 142-31-4, CAS 142-87-0, CAS 151-21-3, CAS 1191-50-0, CAS 1120-01-0).

- For algae: 72h EC50 (Desmodesmus subcapitatus, growth rate) = 11 mg/L (nominal concentration, EU Method C.3, read-across from CAS 90583-18-9)

 

Chronic toxicity key values of C8-18AS Mg & TEA (CAS 85586-38-5):

- For fish: 42d NOEC (Pimephales promelas; mortality and growth) 0.11 mg/L - 1.357 mg/L (read-across from CAS 151-21-3 and CAS 68081-98-1)

- For invertebrates: 21d NOEC (Daphnia magna, reproduction) = 0.22 mg/L (read-across from CAS 142-87-0 and CAS 151-21-3, CAS 1191-50-1, CAS 1120-01-0)

- For algae: 72h NOEC (Desmodesmus subcapitatus, growth rate) = 3 mg/L (nominal concentration, EU Method C.3, read-across from CAS 90583-18-9)

- For microorganisms: 3h EC50 (activated sludge respiration inhibition) = 680 mg/L (nominal concentration, EU method C.11, read-across from CAS 68955-19-1)

 

Classification justification according to CLP:

Based on the data above, C8-18AS Mg & TEA (CAS 85586-38-5) 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 chronic NOEC value was recorded for aquatic invertebrates and reached 0.22 mg/L (thus in the rage of > 0.1 to < 1 mg/L). C8-18AS Mg & TEA (CAS 85586-38-5) 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 data above, C8-18AS Mg & TEA (CAS 85586-38-5) 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. C8-18AS Mg & TEA (CAS 85586-38-5) does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.