Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

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:
4.216 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.422 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:
0.843 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Classification related key information

- Biodegradation in water: not readily biodegradable (0% biodegradation after 56 d, enhanced study OECD 301 F)

- Bioaccumulation: no potential to bioaccumulate (see WoE for the assessment of bioaccumulation attached in chapter 13 IUCLID)

- Aquatic acute toxicity:

Fish: LC50 (96 h) = 18 mg/L (Oncorhynchus mykiss, OECD 203, nominal)

Aquatic invertebrates: EL50 (48 h) = 1.13 mg/L (Daphnia magna, OECD 202, nominal)

Algae: ErC50 (72 h) >10.0 mg/L (Pseudokirchneriella subcapitata, OECD 201, nominal, read-across to CAS 80939 -62 -4)

- Aquatic chronic toxicity:

Fish: No data available

Aquatic invertebrates: No data available

Algae: NOEC (72 h) = 3.2 mg/L (Pseudokirchneriella subcapitata, OECD 201, nominal, read-across to CAS 80939 -62 -4)

ErC10 (72 h) = 4.9 mg/L (Pseudokirchneriella subcapitata, OECD 201, nominal, read-across to CAS 80939 -62 -4)

Classification justification according to CLP

Based on the data above, the substance is considered to be not rapidly degradable in the environment. The most sensitive organism in the available short-term toxicity test were aquatic invertebrates (EL50 (48 h) = 1.13 mg/L. Chronic toxicity data are only available for algae (NOEC = 3.2 mg/L). Therefore the classification was assessed based on both, the acute toxicity and the chronic toxicity data. The substance was classified according to the most stingent outcome. Thus, the substance has to be classified and labelled as “Aquatic Chronic 2” (H411) according to the consolidated version Regulation (EC) No 1272/2008 (CLP) and considering all further amendments.