Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.019 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.186 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
89.4 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.709 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.071 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:
0.131 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC freshwater sediment:

K_(susp-water) = 9.54

RHO_(susp) = 1150

PNEC_freshwater sediment = (K_(susp-water) / RHO_(susp)) * PNEC_water * 1000

= (9.54 / 1150) * 0.0186 * 1000

= 0.154 mg/kg wwt * 4.6

= 0.709 mg/kg dwt

PNEC marine water sediment:

K_(susp-water) = 9.54

RHO_(susp) = 1150

PNEC_marine water sediment = (K_(susp-water) / RHO_(susp)) * PNEC_marine water * 1000

= (9.54 / 1150) * 0.00186 * 1000

= 0.0154 mg/kg wwt * 4.6

= 0.0709 mg/kg dwt

PNEC soil:

K_(soil-water) = 10.6

RHO_(soil) = 1700

PNEC_soil = (K_(soil-water) / RHO_(soil)) * PNEC_water * 1000

= (10.6 / 1700) * 0.0186 * 1000

= 0.116 mg/kg wwt * 1.13

= 0.131 mg/kg dwt

Conclusion on classification

Acute aquatic toxicity:

Algae were the most sensitive species in acute aquatic toxicity tests with Incozol 4, resulting in a 72-hour EC50 of 18.6 mg/L. Based on acute aquatic toxicity results obtained, the test substance was not classified and labelled according to Regulation 1272/2008/EC (CLP), as amended for the tenth time in Regulation (EU) No 2017/776, with respect to short-term (acute) aquatic toxicity.

Chronic aquatic toxicity:

Incozol 4 was tested in an aquatic toxicity test with algae, according EU-method C.3 and OECD guideline 201. The 72-hour EC50 for growth rate was 18.6 mg/L and the 72-hour NOEC 0.0259 mg/L. The EC10 was calculated to be 0.194 mg/L. Due to the big diffenrence between EC50 and NOEC value the classification and labelling is based on the more reliable EC10 value. The test substance was shown to be not ready biodegradable. Thus, the substance has to be classiffied as long-term (chronic) aquatic toxic substance in cat. 2 (H411) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.

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