Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.7 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.17 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.1 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 798.2 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.64 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:
0.25 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1 666.7 mg/kg food
Assessment factor:
30

Additional information

Conclusion on classification

The acute short-term fish, crustacean and algae toxicity of (R)-(-)-butane-1,3-diol is predicted to be L(E)C50 of greater than 100 mg/L; this is in excess of the acute classification cut-off of 1 mg/L.

 

The chronic long-term daphnid toxicity of the readily biodegradable (R)-(-)-butane-1,3-diol is predicted to be 21-day NOEC of greater than 85 mg/L; this is in excess of the chronic classification cut-off of 1 mg/L.

 

There is no evidence that (R)-(-)-butane-1,3-diol may present a danger to the structure and/or the functioning of the stratospheric ozone layer.

 

Based on the information summarized above, (R)-(-)-butane-1,3-diol does not meet the criteria for classification as an environmental hazard, nor does it meet the criteria for classification as a hazard to the ozone layer according to sections 4 and 5. of the European CLP (Regulation (EC) No 1272/2008 as amended).