Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
13.3 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:
22.3 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 values were determined for the substance itself by application of methods provided in ECHA Guidance Chapter R.10 (May 2008).

Conclusion on classification

The substance is an organic mono constituent substance. It is moderately soluble in (773.28 mg/L at 20°C) according to standard methods and stable to hydrolysis.

The short-term toxicity of the registered substance to aquatic organisms was investigated according to OECD guidelines and compliant with GLP. The following toxicity values are available for the substance:

Fish Acute: 96h-LC50 = 20.3 mg/L (based on nominal concentration)

Aquatic invertebrates: 48h-EC50 = 32.4 mg/L (based on nominal concentration)

Algae: 72h-ErC50 = 7.45 mg/L (based on nominal concentration)

The lowest acute aquatic toxicity values based on available data ranges between 1 and 10 mg/L. The long-term toxicity of registered substance to aquatic organisms was not investigated. Thus, there are no adequate chronic toxicity data available.

The degradation of the substance was investigated according to OECD Guidelines:

A reliable study carried out according to OECD Guideline 301D and GLP compliant is available on registered substance. Under the conditions of this study, the registered substance was found readily biodegradable (90% of biodegradation at Day 28 based on O2 consumption). Therefore, the substance is considered as rapidly degradable in aquatic system.

Information on bioaccumulation potential of the submission substance:

No fish BCF is available. log Kow is 2.76 (HPLC method) which indicates low potential for bioaccumulation.

CLP Classification proposal

Acute aquatic hazard: not classified. Reasoning: lowest E(L) C50 higher than 1 mg/L.

Chronic aquatic hazard: not classified. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L) C50 value range between 1 and 10 mg/L, rapidly degradable substance with log Kow < 4.

DSD Classification proposal

not classified. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L) C50 value range between 1 and 10 mg/L, rapidly degradable substance with log Kow < 3.