Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
30 628 640 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3 062 864 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:
6 125 728 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

According to Article 13 of Regulation (EC) No 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. In Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X”, it is stated that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

A read-across approach was applied to this substance and data was compiled from representative source substances to avoid unnecessary animal testing. The target substance will be classified and labelled on this basis.

Environmental fate and pathways

Water solubility

1.39 µg/L (20 °C, pH 6.3, OECD 105)

Partition coefficient

log Kow > 10.0 (25 °C, QSAR, EPI Suite v4.11, KOWWIN v1.68)

Degradation

Readily biodegradable: 86.0% in 28 d (OECD 301 F); read-across

Bioaccumulation

Expert statement: bioaccumulation is assumed to be low.

 

Aquatic short-term toxicity

Fish

No effects up to the limit of water solubility (1.39 µg/L at 20 °C; OECD 203, C. carpio); read-across

Aquatic invertebrates

No effects up to the limit of water solubility (1.39 µg/L at 20 °C; OECD 202, D. magna); read-across

Algae

No effects up to the limit of water solubility (1.39 µg/L at 20 °C, OECD 201, S. capricornutum); read-across

 

Aquatic long-term toxicity

Fish

No data available

Aquatic invertebrates

NOEC (21 d) < 7.0 µg/L (nominal, OECD 211, D. magna)

Algae

No effects up to the limit of water solubility (1.39 µg/L at 20 °C, OECD 201, S. capricornutum); read-across

 

Conclusion on CLP

Data for acute aquatic toxicity is available for all three trophic levels. For chronic aquatic toxicity data is available for two trophic levels (aquatic invertebrates and algae). The substance is readily biodegradable and no short-term effects towards aquatic freshwater organisms were observed up to the limit of the water solubility of the substance. Chronic effects were observed in aquatic invertebrates with a NOEC (21 d) of < 7 µg/L. Based on these results, the substance is classified and labelled as Chronic 1 for long-term environmental hazards according to the consolidated Regulation (EC) No 1272/2008 (dated: 01.01.2017) and further amendments (ATPs).