Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
56 ng/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:
158.1 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
15.8 µg/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:
1.7 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
33.3 mg/kg food
Assessment factor:
10

Additional information

Applied ECHA Guidance on information requirements and chemical safety assessment



  • Chapter R.16: Environmental Exposure Estimation (2016)

  • Chapter R.10: Characterisation of dose [concentration]-response for environment (2008)


 


Freshwater sediment:


Kp susp = Foc susp * Koc


Kp susp = 0.1[kgoc.kgsolid-1]* 2788[L.kg-1]


Kp susp= 278.8 [L.kg-1]


 


Ksusp-water = Fwater-susp + Fsoild-susp * Kp susp /1000 * RHOsolid


Ksusp-water =0.9 [mwater3.msusp-3] + 0.1 [msolid3.msusp-3] * 278.8 [L.kg-1] /1000*2500[kgsolid.msolid-3]


Ksusp-water= 70.6 [m3.m-3]


 


PNECwetsed = Ksusp-water / RHOsusp * PNECwater * 1000


PNECwetsed = 70.6 [m3.m-3] / 1150 [kg.m-3] * 0.00056 [mg.L-1] * 1000


PNECwetsed =0.0344 [mg.kg-1] = 34.4 [μg.kg-1]


 


CONVsed = RHOsed / (Fsolid * RHOsolid)


CONVsed = 1150 [kg-wwt.m-3] / (0.1 [m3.m-3] * 2500 [kgsolid.msolid-3])


CONVsed = 4.6 [kg-wwt.kg-dwt-1]


 


PNECdrysed = PNECwetsed * CONVsed


PNECdrysed =34.4 [μg.kg-1]* 4.6[kg-wwr.kg-dwt-1]


PNECdrysed =158.1 [μg.kg-dwt-1]


 


Marine sediment:


Kp susp = Foc susp * Koc


Kp susp = 0.1[kgoc.kgsolid-1]* 2788[L.kg-1]


Kp susp= 278.8 [L.kg-1]


 


Ksusp-water = Fwater-susp + Fsoild-susp * Kp susp /1000 * RHOsolid


Ksusp-water =0.9 [mwater3.msusp-3] + 0.1 [msolid3.msusp-3] * 278.8 [L.kg-1] /1000*2500[kgsolid.msolid-3]


Ksusp-water= 70.6 [m3.m-3]


 


PNECwetsed = Ksusp-water / RHOsusp * PNECwater * 1000


PNECwetsed = 70.6 [m3.m-3] / 1150 [kg.m-3] * 0.000056 [mg.L-1] * 1000


PNECwetsed =0.00344 [mg.kg-1] = 3.44 [μg.kg-1]


 


CONVsed = RHOsed / (Fsolid * RHOsolid)


CONVsed = 1150 [kg-wwt.m-3] / (0.1 [m3.m-3] * 2500 [kgsolid.msolid-3])


CONVsed = 4.6 [kg-wwt.kg-dwt-1]


 


PNECdrysed = PNECwetsed * CONVsed


PNECdrysed =3.44 [μg.kg-1]* 4.6[kg-wwr.kg-dwt-1]


PNECdrysed =15.8 [μg.kg-dwt-1]


 


Secondary poisoning


NOECmammal, food, chr = NOAEL mammal, oral, chr * CONVmammal


NOECmammal, food, chr = 1E-03 [kg.kg bw-1.d-1] * 10 [kg bw.d–1.kg food–1]


NOECmammal, food, chr = 0.01 [kg.kgfood–1]


 


PNECoral = NOECmammal, food, chr / AForal


PNECoral =0.01 [kg.kgfood–1]/ 300


PNECoral = 3.3 E-5 [kg.kg food-1]


PNECoral = 33.33 [mg.kgfood-1]

Conclusion on classification

Acute toxicity data for the test item are available for three trophic levels (fish, daphnia, algae). The lowest L(E)C50 for Daphnia magna, i.e., the 48-h EC50of 0.56 mg/L (based on dissolved test item concentration; geometric mean measured concentration), was observed in a GLP-conform standard test according to OECD 202 and is selected as acute reference value for classification.


 


The for one trophic level (algae) available chronic 72-h ErC10 of 0.56 mg/L (based on dissolved test item concentration; geometric mean measured concentration) for the effect of the test item on the growth rate of Desmodesmus subspicatus in a GLP-conform standard test according to OECD 201 is selected as long-term reference value for classification- Further, to conclude on the long-term aquatic hazard potential, the lowest acute L(E)C50of 0.56 mg/L for Daphnia magna, the readily biodegradability and the log Kow of 5.3 were considered.


 


Acute (short-term) aquatic hazard:


 


48-h EC50 0.56 mg/L


 


Since the lowest acute L(E)C50 is ≤ 1 mg/L, classification for ACUTE/SHORT-TERM AQUATIC HAZARD Category 1 with an acute M-factor of 1 is required.


 


Chronic (long-term) aquatic hazard based on chronic, acute data and environmental fate of the product:


72-h EC10 0.56 mg/L (algae)


48-h EC50 0.56 mg/L (Daphnia)


readily biodegradable


log Kow: 5.3


 


Since long-term data are available for algae only, the lowest acute L(E)C50 for invertebrate and fish is ≤ 1mg/L and the log Kow is ≥ 4,classification for CHRONIC/LONG-TERM AQUATIC HAZARD Category 1 with a chronic M-factor of 1 is required.


 


According to Regulation (EC) No. 1272/2008 and subsequent adaptations, the test item classifies as Acute (short-term) aquatic hazard, Category Acute 1 (H400: Very toxic to aquatic life) and Long-term aquatic hazard, Category Chronic 1: (H410: Very toxic to aquatic life with long lasting effects), with an acute and chronic M-factor of 1.