Registration Dossier
Registration Dossier
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EC number: 604-721-7 | CAS number: 150114-71-9
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.006 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.21 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.01 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.029 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.046 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:
- 0.022 mg/kg soil dw
- Assessment factor:
- 50
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 333.3 mg/kg food
- Assessment factor:
- 30
Additional information
Conclusion on classification
In accordance with the criteria for classification as defined in Annex I, Regulation EC 1272/2008 (CLP), the substance should be classified as Aquatic Acute Category 1 (H400) Very toxic to aquatic life and Aquatic Chronic 1 (H410) Very toxic to aquatic life with long lasting effects based on the data obtained with aquatic plant Myriophyllum spicatum. The EC50 for growth rate was determined to be 363 µg/L and the NOEC was determined to be 63.9 µg/L. Although Algae is the preferred plant species for environmental classification, the available data indicates that the deep rooted plant Myriophyllum spicatum is the most sensitive species. Therefore based on point 4.1.2.7.1 which states that test data on other species shall also be considered for classification and labelling if the test methodology is suitable. As the study was performed under GLP conditions and in line with the proposed guideline for this endpoint, the data was considered to be the most suitable endpoint for classification and labelling purposes.
Congruently, in accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance should be classified as R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Based on an ErC50 of 363 µg/L in Myriophyllum spicatum, the following concentration limits for calculating the classification of mixtures in accordance with the Directive 1995/45/EEC (DPD) containing this substance are:
Concentration ≥ 25 % : R50 -53
2.5 % ≤ Concentration > 25 % : R51/53
0.25 % ≤ Concentration > 2.5 % : R52/53
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