Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.019 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:
0.028 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The test substance is readily biodegradable according to OECD criteria and considered not bioaccumulative due to the logKow of 2.81 and the low BCF of 12.

Three trophic levels in aquatic toxicology are covered by acute tests. In all three trophic levels the test substance demonstrated to be acutely harmful to aquatic organisms. The LC50 (96 h) for fish is 24 mg/L and the EC50 (48 h) for daphnids was determined to be 53.9 mg/L. Algae turned out to react most sensitive with an ErC50 of 14.4 mg/L after 72 hours of exposure. The EC10 was determined to be 2.51 mg/L and the NOEC was 0.7 mg/L. According to the Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment "an EC10 for a long-term test which is obtained using an appropriate statistical method (usually regression analysis) will be used preferentially. [...] There has been a recommendation within OECD in 1996 to phase out the use of the NOEC, in particular as it can correspond to large and potentially biologically important magnitudes of effect. The advantage of regression method for the estimation of ECx is that information from the whole concentration-effect relationship is taken into account and that confidence intervals can be calculated. These methods result in an ECx, where x is a low effect percentile (e.g. 5-20%). It makes results from different experiments more comparable than NOECs." Therefore, the EC10 instead of the NOEC has been used to derive the classification.

Hence, considering all information on environmental fate and aquatic toxicity, the test substance is not classified according to Regulation (EC) No. 1272/2008.