Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
4 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
44 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.016 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:
0.129 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
8.33 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

Studies from analogue substances are available for evaluating biodegradation and toxicity to aquatic vertebrate and invertebrate species.

 This substance is not biodegradable when tested in accordance with the OECD 301D guideline. The biological oxygen demand was <5% of the chemical oxygen demand in both test concentrations at all sampling dates.

The acute aquatic toxicity was evaluated in fish using rainbow trout in accordance with the OECD 203 guideline. The 96 h LL (Lethal Loading Rate) 50 value of the substance was determined to be 4.4 mg/l. The No Observed Effect Loading rate was 3.2 mg/l loading rate WAF.

The acute toxicity was evaluated in the aquatic invertibrateDaphniaaccording to the OECD 202 guideline. The 48-Hour EL*50 was determined to be 75 mg/L nominal loading rate and the No Observed Effect Loading rate was 32 mg/l nominal loading rate.

The acute toxicity was evaluated in freshwater algae in accordance with OECD Guideline 201. Exposure ofScenedesmus subspicatusto the test material gave an EbL50 (72h) value of 240 mg/L loading rate WAF and an ErL50 (0-72hr) value of 410 mg/L loading rate WAF. The No Observed Effect Loading rate was 220 mg/L loading rate WAF.

Based on the available environmental fate and ecotoxicological data for daphnids, fish and algae, this substance requires classification to the aquatic environment according to Directive 67/548/EEC, the EU CLP (Regulation (EC) No. 1272/2008). This substance has acute aquatic toxicity between 1-10mg/L in the most sensitive species and is not readily biodegradable.