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:
31.3 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

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]

Soil

Kp soil = Foc soil * Koc

Kp soil = 0.02[kgoc.kgsolid-1]* 2788[L.kg-1]

Kp soil= 55.76 [L.kg-1]

 

Henry = 0.45 [Pa.m3.mol-1] (calculated based on measured vapour pressure (at 12°C) and water solubility (at 20°C))

 

Kair-water = Henry / (R * TEMP)

Kair-water = 0.45 [Pa.m3.mol-1]/ (8.314[Pa.m3.mol-1.k-1] *285[K]

Kair-water= 1.90 E-04

 

Ksoil-water = Fair-soil * Kair-water + Fwater-soil+ Fsolid-soil * Kp soil /1000 * RHOsolid

Ksoil-water = 0.2 [mair3.msoil-3] * 1.90 E-04 + 0.2 [mwater3.msoil-3] + 0.6 [msolid3.msoil-3] * 55.76 [L.kg-1] /1000*2500[kgsolid.msolid-3] 

Ksoil-water= 83.84 [m3.m-3]

 

PNECwetsoil= Ksoil-water / RHOsoil * PNECwater * 1000

PNECwet soil = 83.84 [m3.m-3] / 1700 [kg-wwt.m-3] * 0.00056 [mg.L-1] * 1000

PNECwetsoil = 0.02762 [mg.kg-wwt-1] = 27.62 [μg.kg-wwt-1]

 

CONVsoil = RHOsoil / Fsolid * RHOsolid

CONVsoil = 1700 [kg-wwt.m-3] / 0.6 [m3.m-3] * 2500 [kgsolid.msolid-3]

CONVsoil = 1.13 [kg-wwt.kg-dwt-1]

 

PNECdrysoil = PNECwetsoil * CONVsoil

PNECdrysoil =27.62 [μg.kg-wwt-1] * 1.13[kg-wwr.kg-dwt-1]

PNECdrysoil =31.3 [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.

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