Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
8.8 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.88 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.105 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:
0.206 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
20 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

The substance is an organic substance. It is slightly soluble in water (ca. 25.83 mg/L according to standard methods) and log Kow is 4.4.

The following toxicity values are available for the substance:

Fish Acute

Lepomis macrochirus: 96h-LC50 = 1.1 mg/L

QSAR estimation based on Mode of Action 1: 96h-LC50 = 1.3 mg/L

Aquatic invertebrates

Daphnia magna: 48h-EC50 = 1.4 mg/L

Daphnia magna: 48h-EC50 = 1.3 mg/L

QSAR estimation based on Mode of Action 1: 48h-EC50 = 1.6 mg/L

Algae

Selenastrum capricornatum: 96h-EC50 = 2.5 mg/L

QSAR estimation based on Mode of Action 1: 72h-EC50 = 1.4 mg/L

The lowest acute aquatic toxicity values based on available data ranges between 1.0 and 10 mg/L.

The following chronic toxicity values are available for the substance:

Fish Chronic

QSAR estimation based on Mode of Action 1: 28d-NOEC = 0.23 mg/L

Aquatic invertebrates

Daphnia magna: 21d-NOEC = 0.48 mg/L

QSAR estimation based on Mode of Action 1: 21d-NOEC = 0.14 mg/L

Algae

Selenastrum capricornatum: 96h-NOEC= 0.44 mg/L

QSAR estimation based on Mode of Action 1: NOEC = 0.49 mg/L

Biodegradation:

2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-(2E)-buten-1-ol was found to be ultimately biodegradable (50% of CO2 production occurred at approximately 14.4 days) in an OECD 314B assay (Biodegradation in activated sludge test - Schaefer, 2010).

The substance is considered as not readily biodegradable according to the criteria of the OECD 301 guideline nor inherently biodegradable according to the criteria of the OECD guideline for testing chemicals in aquatic system.

Experimental information on bioaccumulation potential of the submission substance is not available.

CLP Classification proposal

Acute aquatic hazard: Not classified. M-Factor: not relevant.

Reasoning: lowest E(L) C50 higher than 1.0 mg/L.

Chronic aquatic hazard: Category 2. M-Factor: not relevant.

Reasoning (1): lowest acute E(L) C50 value range between 1 and 10 mg/L, not rapidly degradable substance with Log Kow > 4.

Reasoning (2): lowest chronic NOEC value (experimental data supported by QSAR data) range between 0.1 and 1.0 mg/L.

DSD Classification proposal

N; R51/53.

Reasoning: lowest acute E(L) C50 value range between 1 and 10 mg/L, not readily biodegradable substance with log Kow > 3.