Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.006 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
3.83 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.002 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECs

The PNECs for the different compartment have been calculated either by application an assessment factor (PNECfreshwater, PNECmarine water, PNECintermittent release and PNECstp) or using the equilibrium assumption method (PNECsediment freshwater, PNECsediment marine water and PNECsoil). The PNECoral is not considered as relevant due to lack of bioaccumulation potential. The utilized procedures are described in detail in the ECHA REACH Guidance of May 2008, Chapter R.10 ("Guidance on information requirements and chemical safety assessment").

Classification and Labelling

Most critical parameter was obtained by the conducted experiment with Pseudokirchneriella subcapitata according to ‘Testing Methods for New Chemical Substances’ of Pharmaceutical and Food Safety Bureau (PFSB), Ministry of Health, Labour and Welfare and Environmental Policy Bureau-Ministry of the Environment (November 21, 2003 No. 1121002; November 13, 2003, No. 2; Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry No. 031121002) by IDEA (2010). The ErC50(72h) value of 0.553 mg/L indicates a potential of acute toxicity towards this species and a NOECr (72h) of 0.202 mg/L indicates a potential of chronic toxicity. 4-phenylbutenone is readily biodegradable (81 % degradation after 28 d, Kanne, 1993) and the determined Bioconcentration Factor (BCF) of 10.8 (Chemservice S.A., 2011) as well as the obtained logPow (2.04, QSAR and several databases) indicate no potential to accumulate in biota. The substance has therefore to be classified and labelled with H400 "Very toxic to aquatic life" and H412 "Harmful to aquatic life with long lasting effects" according to Regulation (EC) No 1272/2008 concerning environmental issues.

Conclusion on classification

Considering all available data of the acute and chronic toxicity tests on aquatic organisms, environmental fate issues and taking into account the provisions laid down in Regulation (EC) No 1272 /2008, the substance needs to be classified as H400 "Very toxic to aquatic life" with respect to acute and as H412 "Harmful to aquatic life with long lasting effects" with respect to long-term toxicity towards environmental organisms.