4-Penten-2-ol, 3,3-dimethyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)-, (4E)-

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

1.1 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

11 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.11 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

1.1 µg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

0.1 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.225 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.023 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:

0.044 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

222.2 mg/kg food

Assessment factor:

90

Additional information

Aquatic toxicity

To assess the short-term toxicity of the registered substance to aquatic organisms, experimental studies of reliability 1 (Klimisch rating), based on international guidelines, are available on the three aquatic trophic levels (algae, aquatic invertebrate and fish).Among all acute data available, the fish Danio rerio is the most sensitive species with a 96h-LC50 at 1.1 mg/L based on mean measured concentrations. For the aquatic invertebrateDaphnia magna, the 48h-EC50 was determined to be 1.6 mg/L based on mean measured concentrations, and for the algae Pseudokirchneriella subcapitata, the 72h-ErC50 and ErC10 (based on growth rate) were determined to be 5.71 mg/L and 1.38 mg/L, respectively, based on initial measured concentration.

In addition, to assess the toxicity of the registered substance to microorganisms, one experimental study of relability 2 (Klimisch rating), based on international guideline, is available on Pseudomonas putida. None of the concentrations tested between 0.05 and 10 mgL resulted in an inhibition of bacterial growth of P. putida after 16 hours of exposure. Therefore, the 16h-NOEC is equivalent to 10 mg/L for this bacterial strain. However, considering the toxicity effect observed in the biodegradation studies mentioned in the present dossier, the toxic effect observed in activated sludge micro-organisms up to 84 days at the tested concentration of 2 mg/L (AkzoNobel (2012) OECD 301D study) is considered relevant for chemical safety assessment. Therefore, the estimated NOEC for the toxicity to STP micro-organisms can be expected at 1.0 mg/L (by dividing the toxic concentration by 2).

Sediment/Terrestrial toxicity

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 sub-chronic 90 days toxicity study on rats was used to derive the PNECoral.

Environmental fate and pathways

The registered substance is hydrolytically stable at any pH (from 2 to 12) and not readily biodegradable.Therefore, in the absence of valid simulation studies, the registered substance can be considered as potentially persistent (potential P) or potentially very persistent (potential vP) in the environment. With an experimental BCF comprised between 46 and 60, the registered substance is not bioaccumulable. Finally, the substance is slightly mobile in soils with an adsorption coefficient estimated at 2013 L/Kg (log Koc = 3.30).

Conclusion on classification

No harmonised classification is available.

Data available:

- lowest L(E)C50 value comprised between 1 and 10 mg/L;

- ErC10 algae > 1 mg/L;

- Not rapidly degradable;

- experimental BCF = 46 -60.

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