Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
180 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.01 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:
0.026 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Water compartment is represented by a PNEC derived from an acute short-term value of LC50. Long-term toxicity is not available and testing shall be proposed by the registrant if the chemical safety assessment according to Annex I of the REACH Regulation 1907/2006 indicates the need to investigate further the effects on aquatic organisms.

SEDIMENT

PNEC sediment using Equilibrium Partitioning Method:

The following formula is applied:

PNECsed= Ksusp-water/RHOsusp*PNECwater*1000

PNECwater Predicted No Effect Concentration in water [mg.l-1] 0,1
RHOsusp bulk density of wet suspended matter [kg.m-3] 1150
Ksusp water partition coefficient suspended matter water [m3.m-3] 1.1
PNECsed Predicted No Effect Concentration in sediment [mg.kg-1of wet sediment] 0,0957

Ksusp water= Fwatersusp+ Fsolidsusp*Kpsusp/1000*RHOsolid

Kpsusp= Focsusp*Koc

Therefore PNEC sediments = (1.1/1150)*0,1*1000 = 0,0957 mg/kg

PNEC marine sediment using Equilibrium Partitioning Method:

Being marine PNEC usually derived by freshwater PNEC with an adding assessment factor of 10, consequently the marine sediment PNEC can be directly derived from PNEC sediment with an assessment factor of 10.

Therefore PNEC marine sediments = 0,0095 mg/kg

SOIL

PNEC soil using Equilibrium Partitioning Method:

The following formula is applied:

PNECsoil= Ksoil-water/RHOsoil*PNECwater*1000

PNECwater Predicted No Effect Concentration in water [mg.l-1] 0,1
RHOsoil bulk density of soil [kg.m-3] 1700
Ksoil water partition coefficient soil water [m3.m-3] 0,44
PNECsoil Predicted No Effect Concentration in soil [mg.kg-1 of wet soil] 0.0259

Ksoil water= Fairsoil*Kair-water+Fwatersoil+ Fsolidsoil*Kpsoil/1000*RHOsolid

Kpsoil= Focsoil*Koc

Therefore PNEC soil = (0,44/1700)*0,1*1000= 0. 0259 mg/kg

Conclusion on classification

The substance Sulfosuccinate of lanolin alcohol is not classified toxic for the environmental compartment because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:

Acute (short-term) data available

Category Acute 1:

96 hr LC50 (for fish) ≤ 1 mg/l and/or

48 hr EC50 (for crustacea) ≤ 1 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l  

Substances for which adequate chronic toxicity data are not available.

Category Chronic 1:

96 hr LC50 (for fish) ≤ 1 mg/l and/or

48 hr EC50 (for crustacea) ≤ 1 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/land the substance is not rapidly degradable and/or the experimentally determined BCF≥ 500 (or, if absent, the log Kow≥ 4)

Category Chronic 2:

96 hr LC50 (for fish) > 1 to ≤10 mg/l and/or

48 hr EC50 (for crustacea) > 1 to ≤10 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) > 1 to ≤10 mg/land the substance is not rapidly degradable and/or the experimentally determined BCF≥ 500 (or, if absent, the log Kow≥ 4)

Category Chronic 3:

96 hr LC50 (for fish) > 10 to ≤ 100 mg/l and/or

48 hr EC50 (for crustacea) > 10 to ≤ 100 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/land the substance is not rapidly degradable and/or the experimentally determined BCF≥ 500 (or, if absent, the log Kow≥ 4)

Acute short-term data on fish, Daphnia and algae are > 100 mg/L.