Registration Dossier
Registration Dossier
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EC number: 309-798-8 | CAS number: 101012-97-9
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.012 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.123 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:
- 49 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 46.6 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 4.66 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:
- 1 mg/kg soil dw
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
The PNECs will be recalculated when further data have become available as a long-term toxicity test on aquatic invertebrates is planned to be performed.
Conclusion on classification
Official classification regarding environmental hazards
Aquatic compartment
In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.1, the substance is not officially classified.
In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.2, the substance is not officially classified.
Self-classification
Aquatic compartment
Following CLP (GHS-EU), the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute data, the substance is to be classified as chronically hazardous to the aquatic environment into the Category Chronic 3.
Rationale:
The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L.
Chronic data are available only for algae, therefore classification is based on the available chronic and acute toxicity data.
- Chronic toxicity data:
Chronic data are available only for algae (NOErL = 1 mg/L; ErL10 = 2.55 mg/L; loading; (#)) indicating that the substance does not present a long-term hazard according to the categories outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) for non-rapidly degradable substances.
- Acute toxicity data:
Acute toxicity to aquatic organisms (LL/EL50) is between10 and≤100 mg/L (loading). The substance is not rapidly biodegradable and the log Kow is expected to be ≥4. Therefore, the substance is to be classified as chronically hazardous to the aquatic environment (Category Chronic 3) based on the categories outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008.
(#) The ErL10 was determined to be 2.55 mg/L (loading) and the NOErL was 1.0 mg/L (loading). 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 EL10 (loading) instead of the NOEL (loading) has been used to derive the classification
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