Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
18.57 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:
30.3 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC derivation was as follows justified:

PNEC freshwater sediment:

K_(susp-water) = 4.04

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (4.04/1150) * 1.15E-02 * 1000

= 0.040 mg/kg-ww -> 0.1857 mg/kg-dw

PNEC marine water sediment:

K_(susp-water) = 4.04

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

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

= (4.04/1150) * 1.15E-03 * 1000

= 0.004 mg/kg-ww -> 0.0185 mg/kg-dw

PNEC soil:

K_(soil-water) = 3.40

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

= (K_(soil-water)/ RHO_(soil)) * PNEC_freshwater * 1000

= (3.4/1700) * 1.15E-02 * 1000

= 0.0268 mg/kg-ww -> 0.0303 mg/kg-dw

Conclusion on classification

Classification related key information

- Biodegradation: Readily biodegradable: 86 % after 28 days (OECD 301 B)

- Bioaccumulation: log Pow 3.55 (EU Method A.8)

Aquatic acute toxicity

- Fish: LC50 (96 h) = 11.5 mg/L (geometric mean, Oncorhychus mykiss, OECD 203)

- Aquatic invertebrates: EC50 (48 h) = 42.0 mg/L (nominal, Daphnia magna, OECD 202)

- Algae: ErC50 (72 h) = 39.0 mg/L (arithmetic mean, Pseudokirchneriella subcapitata, OECD 201)

Since the L(E)C50 of fish, daphnia and algae are above 1 mg/L test item, classification for acute/short-term aquatic hazard is not required according to Table 4.1.0(a) of Regulation (EC) No 1272/2008.

 

Aquatic chronic toxicity

- Algae: ErC10 (72 h) = 18.0 mg/L (arithmetic mean, Pseudokirchneriella subcapitata, OECD 201)

Chronic toxicity data are only available for one trophic level, algae; the respective ErC10 of 18 mg/L for growth rate inhibition is above the long-term classification criteria of rapidly degradable substances for which there are adequate chronic toxicity data available according to Table 4.1.0(b)(ii) of Regulation (EC) No 1272/2008.

Regarding the other trophic levels, acute toxicity data are assessed; the lowest acute toxicity value for the other trophic levels is the 96-hour LC50 of 11.5 mg/L for Oncorhynchus mykiss, the test item is readily biodegradable and the log Pow is < 4. According to Table 4.1.0(b)(iii) of Regulation (EC) No 1272/2008 and subsequent adaptations, the substance meets not the long-term classification criteria as hazard to the aquatic environment.

Classification according to CLP

Based on the data above, the substance has not to be classified for acute or chronic toxicity according to Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.