Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.606 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
3.03 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.061 µg/L
Assessment factor:
5 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.303 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
15.7 µg/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:
31.7 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
8.76 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

(-)-alpha-Pinene is an organic substance. It is very slightly soluble in water (2.75 mg/L according to the slow-stirring method).

The short-term toxicity of (-)-alpha-pinene to aquatic organisms was investigated according to OECD guidelines and GLP. The toxicity values below are available for the substance.

Fish Acute: LC50(96h) = 0.303 mg/L (measured concentration)

Aquatic invertebrates: EC50(48 h)= 0.475 mg/L (measured concentrations)

Algae: ErC50(72 h) = 0.31 mg/L (predicted by QSAR)

The lowest acute aquatic toxicity values based on available data ranges between 0.1 and 1.0 mg/L. There are no adequate chronic toxicity data available.

The degradation of alpha-pinene multiconstituent was investigated.

A reliable study was carried out according to Guideline OECD 301D and GLP. Under the conditions of this study, alpha-pinene multiconstituent was found readily biodegradable (68% of biodegradation on Day 28 based on oxygen consumption).

CLP Classification (Regulation (EC) No 1272/2008)

Acute aquatic hazard:

(-)-alpha-Pinene is classified under CLP Regulation for acute toxic hazard - Category 1. The lowest LC50value (fish) ranges between 0.1 and 1 mg/L.

Chronic aquatic hazard:

(-)-alpha-Pinene is classified under CLP Regulation for chronic toxic hazard - Category 1. The lowest acute LC50value (algae) ranges between 0.1 and 1 mg/L. The substance is readily biodegradable but log Kow > 4.

M-Factor: 1.

DSD Classification (Directive 67/548/EEC)

(-)-alpha-Pinene is classified dangerous for the environment: H400/H410. The lowest acute LC50value (fish) ranges between 0.1 and 1 mg/L. The substance is readily biodegradable but log Kow > 4.