Registration Dossier

Ecotoxicological information

Ecotoxicological Summary

Currently viewing:

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
5.3 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
53 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.21 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:
0.42 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Environmental fate and pathways:

Based on the key biodegradation study (EC Directive 92/69/EEC C.4 -C), the substance is considered to be readily biodegradable. The bioconcentration factor (BCF) was estimated using a QSAR at 334.6 L/kg whole body weight. Finally, the adsorption coefficient (log Koc) of the substance was determined to be in the range of 3.51 to 3.66 (OECD Guideline 121, EU Method C.19), corresponding to two isomeric forms. This result indicates that the substance is environmentally slightly mobile (according to P.J. McCall et al., 1980).

Aquatic toxicity:

Acute data with varying reliabilities (Klimisch rating), based on international or national guidelines, are available for three trophic levels: Algae, Invertebrates, Fish and microorganisms. Among all data available, the aquatic invertebrate, Daphnia magna, is the most sensitive species with a 48h-EC50 at 5.3 mg/L. For algae and fish, the L(E)C50 values were determined at 22 mg/L (based on growth rate) and 8.6 mg/L, respectively. For microorganisms, the 3h-EC50 and 3h-EC10 values were determined at 302 mg/L and 122 mg/L respectively.

In accordance with column 2 of REACH annex IX, further testing on the long-term effects on aquatic organisms does not need to be conducted as the chemical safety assessment does not indicate a need for further investigation.

Terrestrial toxicity:

Based on a conservative estimation from Chesar, the chemical safety assessment of the substance indicates no need to investigate terrestrial testing. For this reason, terrestrial toxicity studies are scientifically unjustified.

Conclusion on classification

1 mg/L < E(L)C50 < 10 mg/L; readily biodegradable; log Kow = 4.8 but estimated BCF = 334.6 L/kg.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): According to the 2nd ATP, the substance is not classified for the environment.