Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

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:
0.67 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.067 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:
0.025 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
111.1 mg/kg food
Assessment factor:
90

Additional information

Aquatic toxicity

Studies Klimisch rated reliability 2 based on international guidelines are available for three aquatic trophic levels (algae, aquatic invertebrate and fish) on an analogue substance, METHYL 3-OXO-2-PENTYL-1-CYCLOPENTANE ACETATE (quality High Trans isomer). This read-across substance is a mixture of two diastereomers, approximately 10% cis- and 90% trans-diastereomers of which the cis-diastereomer corresponds to the registered substance. This supporting substance is considered adequate for read-across purposes based on similar physico-chemical properties and readily biodegradability of the registered substance and the analogue material used (see IUCLID section 13).

Among all data available, the aquatic invertebrate Daphnia magna is the most sensitive species with a 48h-EC50 at 8.25 mg/L. A chronic toxicity data is also available with a 21d-EC10 for reproduction at 1.86 mg/L. On the fish Oryzias latipes, the 96h-LC50 was determined to be 19 mg/L, and on the algae Pseudokirchneriella subcapitata, the 72h-ErC50 and NOECr (based on growth rate) were determined to be 45.9 mg/L and 11.7 mg/L, respectively. Due to the lower sensitivity of the fish compared to that of the daphnids, a fish chronic study was not considered necessary.

In addition, there is no need to perform an activated sludge inhibition test, in accordance with column 2 of REACH Annex VIII, because the substance is readily biodegradable. The applied test concentration in the key biodegradation study (101 mg/L) is in the range of concentrations that can be expected in the influent of a sewage treatment plant, and no inhibition effects on the activity of microorganisms was observed.

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 90-day dietary repeat dose toxicity study and the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test on rats were used to derive the PNECoral.

Environmental fate and pathways

Based on the biodegradation studies (OECD Guideline 301 F), the registered substance, METHYL CIS-3-OXO-2-PENTYL-1-CYCLOPENTANE ACETATE, is considered readily biodegradable. Therefore, in accordance with REACH Annex VIII column 2, hydrolysis study does not need to be conducted. Finally, the registered substance is considered to have a low potential for adsorption and bioaccumulation (octanol water partition coefficient, log Kow < 3.0 based on a read-across substance). The adsorption study does not need to be conducted, according to REACH Annex VIII column 2.

Conclusion on classification

No harmonised classification is available on the registered substance, neither on the analogue substance.

Lowest EC10 or NOEC > 1 mg/L; 1 < lowest L(E)C50 < 10 mg/L; readily biodegradable; log Kow < 3.

Classification according to the Annex VI of the Directive 67/548/EEC: The registered substance is not classified for the environment.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The registered substance is not classified for the environment.

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