2,2,5-trimethyl-5-pentylcyclopentan-1-one

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

1.3 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

13 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.13 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.798 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.08 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:

0.159 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

45.5 mg/kg food

Assessment factor:

300

Additional information

Aquatic toxicology:

Four valid acute experimental studies based on international guidelines and one QSAR result are available to assess the aquatic toxicity of the registered substance.

Among all data available, a toxic effect was observed for fish and aquatic invertebrates. The 96h-LC50 for fish and 48h-EC50 for Daphnia magna were 1.3 mg/L and 2.9 mg/L, respectively. For the algae Pseudokirchneriella subcapitata, the 72h-ErC50 was greater than 3.4 mg/L, the highest attainable average test substance concentration achievable, despite precautions being taken to reduce volatility. In addition, the registered substance was not toxic to activated sludge at or below the highest loading rate tested, 1000 mg/L.

Sediment, terrestrial toxicity and hazard for predators

In the absence of any ecotoxicological data for sediment-dwelling/soil organisms, the PNEC sediment/soil were calculated using the equilibrium partitioning method (EPM). Furthermore, no toxicity studies reporting the secondary poisoning effects on bird were available, therefore the combined 28 -day repeated dose toxicity study performed on the registered substance was used to derive the PNECoral.

Environmental fate and pathways:

The registered substance is not readily biodegradable and is considered hydrolytically stable at environmentally relevant pH.

However, the degradation observed strongly suggests that it is primarily biodegradable within 28 days and the degradation products continue to degrade slowly thereafter.

Therefore, the substance is not considered persistent. The registered substance is considered environmentally immobile in soils (according to P.J. McCall et al., 1980) with a Koc value at 6100 L/kg (log Koc = 3.78) and with a BCF value at 883, is considered to be bioaccumulative according to CLP criteria (>500) but is not considered to be bioaccumulative according to PBT criteria (< 2000).

Conclusion on classification

No harmonised classification is available on the registered substance.

1 < lowest E(L)C50 value < 10 mg/L; 0.1 < NOEC algae < 1 mg/L; not readily biodegradable; log Kow > 4.0 and predicted BCF > 500 (= 883)

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The registered substance is classified as Chronic Category 2 (H411) for the environment.