Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.012 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.034 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:
1.35 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.042 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:
0.077 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; log Pow < -1.578 at 20 ºC (OECD 105)

Water solubility: >428 g/L at 20 ºC (EU method A.6)

 

Acute toxicity key values for C12-14 AS MIPA (CAS 85681-66-9):

- For fish: 96h LC50 (Danio rerio, mortality) = 3.69 mg/L (nominal concentration, OECD 203)

- For invertebrates: 48h EC50 (Daphnia magna, mobility) = 3.41 mg/L (nominal concentration, OECD 202)

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

 

Chronic toxicity key values for C12-14 AS MIPA (CAS 85681-66-9):

- 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) = 0.12 mg/L (measured concentration, EPA-600/489/001)

- For algae: 72h NOEC (Scenedesmus subspicatus, 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 rate = 135 mg/L (nominal concentration, similar to OECD 209, read-across from CAS 151-21-3)

 

Classification justification according to CLP:

Based on the data above, C12-14 AS MIPA (CAS 85681-66-9) is considered to be rapidly degradable and has a low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 is above 1 mg/L for fish, invertebrates and algae. Valid chronic toxicity data are also available for all trophic levels. The lowest NOEC is 0.12 mg/L (thus in a range > 0.1 to < 1 mg/L) for aquatic invertebrates. C12-14 AS MIPA (CAS 85681-66-9) therefore needs to be classified and labeled as environmental hazard Chronic Cat. 3 according to Regulation (EC) No.1272/2008 (6th ATP) and Regulation (EU) No. 286/2011 (2nd ATP).

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

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

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