Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.5 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
35 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.35 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
3.5 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
16.394 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:
31.047 µg/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 and fish are available for the substance. The EL50 value for Daphnia is >100 mg/l, the ErL50 for algae is also >100 mg/L. For fish the LC50 was determined based on a read across substance and concluded at 0.225 mg/L. Based on the lowest available acute data for fish with an LC50 value of 0.225 mg/L the substance needs to be classified for acute hazard (H400).

The lowest chronic available value is the NOErL of algae being 100 mg/L. The substance is not readily biodegradable and has a log Kow≥ 4. In view of the acute fish result the substance needs to be classified for chronic toxicity according to Figure 4.1.1and Table 4.1.0, (b) iii of CLP, resulting in Aquatic Chronic Category 1 and H410 classification. The use of ECOSAR-predicted chronic ecotoxicological values does not change the classification conclusions.

Overall, it can be concluded that Tetrahydrolinalyl acetate needs to be classified as Aquatic Acute 1 (H400) and Chronic 1 (H410) in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC and its amendments).

An M factor of 1 is indicated for acute toxicity.