Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.12 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1.2 µg/L

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.103 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:
0.02 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Short-term toxicity tests for algae, Daphnia are available for the substance. The LC50 value for fish is calculated by ECOSAR to be 1.21 mg/L and the EC50 for Daphnia is 2.8 mg/l, whereas the ErC50 for algae is 7.5 mg/L. Based on the lowest available acute data for fish with an LC50 value of 1.21 mg/L, the substance does not need to be classified for acute aquatic toxicity according to Table 4.1.0 (a) of CLP.

As one chronic value is available for algae, the chronic C&L needs to be derived on both chronic and acute toxicity data and the most stringent outcome needs to be taken into consideration.

The only chronic value (NOErC) is derived in the algae study (2.1 mg/L). In combination with the substance not being rapidly degradable this would not lead to classification according to Table 4.1.0 (b) (i) of CLP. However, in view of the acute results and the Log Kow = 4.4, the substance needs to be classified for long-term aquatic toxicity according to Figure 4.1.1 and Table 4.1.0, (b) iii of CLP, resulting in Aquatic Chronic Category 2 and H411 classification.

 

Overall, it can be concluded that ethyllinalyl acetate needs to be classified as Aquatic Chronic 2 (H411) in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).