Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
5.4 µg/L
Assessment factor:
10

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.54 µg/L
Assessment factor:
100

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1 710 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
171 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:
1.87 mg/kg soil dw
Assessment factor:
50

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

The substance is highly insoluble and unlikely to cross biological membranes in the aquatic phase exposures (log Kow = 7.49, and log Koc > 6.5; MW > 200 g/mol). Aquatic toxicity of the substance has been studied in three long-term tests with the aid of a solvent. All tests were conducted with a nominal concentration up to 100 µg/L.

No effects were seen in studies with early life-stage fish (OECD TG 210) and algae (OECD TG 211), while limited effects were observed in the long-term study with daphniids, where the reproduction was inhibited by 20 % when compared to the controls at the highest exposure treatment at 54 µg/L (arithmetic mean of the measured test concentration. All aquatic studies showed no effects at the limit of water solubility (0.25 µg/L). The substance has a log Kow > 4 and high adsorptive potential log Koc = 6.5 (calculated) suggesting the fate of the substance does not remain the water phase and since no effects have been seen at limit of solubility it is expected aquatic toxicity is not of concern. In addition, according to ECHA guidance R7b, results from tests above the limit of solubility should not be interpreted as pelagic toxicity, but as confounded by physical effects.

According to current test results, Farnesane does not demonstrate ready biodegradability under the conditions of OECD TG 301B while modelled data (EPISuite v 4.11, BIOWIN v4.10 and BioHCwin v1.01), predict that farnesane will be ultimately biodegradable (in a period of weeks to months), and that it has a predicted half-life of 22 days in the environment. Farnesane has calculated log Kow of 7.49 which is supported by an experimentally derived value of > 7.2 (IUCLID section 4.7).

As a conservative measure, Aquatic Chronic 4 classification is applied to the test substance.

A testing proposal has been submitted to identify if the persistence, followed by bioaccumulation potential of the substance.