Registration Dossier
Registration Dossier
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EC number: 433-100-1 | CAS number: -
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.1 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.01 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.392 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.039 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:
- 0.02 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
PNEC calculations:
Dilithium sebacate (main constituent):
PNEC freshwater sediment:
K_(susp-water) = 0.979
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_freshwater sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000
= (0.979/1150)* 0.1 *1000
= 0.0851 mg/kg wwt
= 0.392 mg/kg dw
PNEC marine water sediment:
K_(susp-water) = 0.979
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_marine water sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000
= (0.979 /1150)*0.01* 1000
= 0.00851 mg/kg wwt
=0.0392 mg/kg dw
PNEC soil:
K_(soil-water) = 0.295
RHO_(soil) = 1700
Conversion factor (wwt -> dwt): 1.13
PNEC_soil
= (K_(soil-water)/ RHO_(soil))*PNEC_freshwater* 1000
= (0.295 /1700)*0.1* 1000
= 0.0174 mg/kg wwt
= 0.0196 mg/kg dw
Lithium salt of sebacic acid stearylamide:
PNEC freshwater sediment:
K_(susp-water) = 495
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_freshwater sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000
= (495/1150)* 0.1 *1000
= 43.0 mg/kg wwt
= 198 mg/kg dw
PNEC marine water sediment:
K_(susp-water) = 495
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_marine water sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000
= (495/1150)*0.01* 1000
= 4.3 mg/kg wwt
= 19.8 mg/kg dw
PNEC soil:
K_(soil-water) = 593
RHO_(soil) = 1700
Conversion factor (wwt -> dwt): 1.13
PNEC_soil
= (K_(soil-water)/ RHO_(soil))*PNEC_freshwater* 1000
= (593/1700)*0.1* 1000
= 34.9 mg/kg wwt
= 39.4 mg/kg dw
Sebacic acid distearylamide:
PNEC freshwater sediment:
K_(susp-water) = 3.78E+03
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_freshwater sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000
= (3.78E+03/1150)* 0.1 *1000
= 329 mg/kg wwt
= 1510 mg/kg dw
PNEC marine water sediment:
K_(susp-water) = 3.78E+03
RHO_(susp) = 1150
Conversion factor (wwt -> dwt): 4.6
PNEC_marine water sediment
= (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000
= (3.78E+03/1150)*0.01* 1000
= 32.9 mg/kg wwt
= 151 mg/kg dw
PNEC soil:
K_(soil-water) = 4.5E+03
RHO_(soil) = 1700
Conversion factor (wwt -> dwt): 1.13
PNEC_soil
= (K_(soil-water)/ RHO_(soil))*PNEC_freshwater* 1000
= (4.5E+03/1700)*0.1* 1000
= 265 mg/kg wwt
= 299 mg/kg dw
PNECoral predator secondary poisoning:
NOAELoral,predator: 1000 mg/kg bw/day
Conversion factor CONVpredator (NOAELoral,predator -> NOAECoral,predator): 20 (for rat)
Assessment factor AForal,predator: 300 (for 28 day study)
PNECoral,predator
= (NOAELoral,predator* CONVpredator)/AForal,predator
= (1000*20)/300
= 66.67 mg/kg food
Conclusion on classification
No effects were observed in acute aquatic toxicity tests. LC50, EC50 and IC50 values were greater than 100 mg/L (limit concentration). According to Directive 67/548/EEC (DSD) and Regulation (EC) 1272/2008/EU (CLP) the substance has not to be classified regarding acute toxicity to the environment.
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