Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.72 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.16 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.63 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Ethanol:

Formula for the calculation of PNECsed using the equilibrium partitioning approach for sediment (as shown in the REACH guidance, chapter R16):

PNEC(sed) = (Ksed-water x PNEC(aqua) / RHOsed) * 1000

PNEC(sed) Predicted No Effect Concentration in sediment [mg/kg]: as shown above (equation R10.2).

Kp-sed [l/kg]: 0.231 (equation R16 -12)

Ksusp-water partition coefficient freshwater sediment / water [m3/m3]: 0.929 (equation R16 -13)

RHOsed bulk density of freshwater sediment matter [kg/m3]: 1150

PNECaqua Predicted No Effect Concentration in water [mg/kg]: as shown above.

PNEC marine predicted to be 0.658mg/kg based on same method and the PNEC(marine) shown above.

The PNEC oral is derived using the critical oral mammalian NOAEL (in mg/kg bw ) as a starting point. This is then converted to a NOEC (in mg/kg food) using the conversion factors in table R10-12 of the guidance from which the PNEC is derived by using the appropriate assessment factor in table R10 -13.

Isopropanol:

The values derived as PNECs above are fully in line with observed results for aquatic toxicity as this substance shows only effects, if at all, to aquatic organisms way above all thresholds for classification & labelling (100 mg/l) for some species even orders of magnitudes above. In addition the substance is readily biodegradable as shown in the data sections and a hazard to aquatic organisms is not expected.

Conclusion on classification

Based on data from the two constituents it can be concluded that the reaction mass does not need to be classified for envrionmental properties according to DSD or CLP.

Ethanol:

The acute toxicity of ethanol to aquatic species is >100mg/l for all trophic levels. This coupled with its ready biodegradability mean that it does not meet the criteria for classification.

Isopropanol:

Based on available data substance is neither classifiable for acute nor chronic aquatic toxicity according to CLP (EC No 1272/2008)