Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

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:
4.46 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.446 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:
0.825 µg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
47.56 mg/kg food
Assessment factor:
90

Additional information

The computation of PNEC values was conducted in accordance with ECHA guidance R.10. The 96-hour LC50 value of 0.117 mg/L observed in the valid acute aquatic toxicity test conducted with zebra fish forms the basis for the computation of the aquatic PNEC values. PNEC sediment and PNEC soil were calculated by using the equilibrium-partitioning method. According to ECHA guidance R.7b, the non-inhibitory concentration observed in a toxicity control of a valid ready biodegradability study can be interpreted as the NOEC for microbial toxicity. No inhibitory effect observed at a nominal test concentration of 100 mg/L. The PNEC oral was derived from a NOAEL of 214 mg/kg bw/day observed in an oral sub-chronic feeding study in rats.

Conclusion on classification

CLP Regulation:

Acute toxicity:

The 96-hour LC50 value of 0.117 mg/L observed in the valid acute aquatic toxicity test conducted with zebra fish triggers classification for acute (short-term) aquatic hazard (Category Acute 1, H400) in accordance with Regulation (EC) No 1272/2008 (see Table 4.1.0).

Chronic toxicity:

The 72-hour NOEC and EC10 values within the range of 0.1 to 1.0 mg/L, which were found in the algal toxicity study, trigger the classification for long-term aquatic hazard into Category Chronic 3 (for rapidly degradable substances) in accordance with Commission Regulation (EU) No 286/2011 (see Table 4.1.0). No classification based on the acute data is applicable as the substance is readily biodegradable and the log Kow is < 4.

DSD Regulation:

The substance is to be classified with R50/R53 according to Commission Directive 2001/59/EC adapting for the 28th time Council Directive 67/548/EEC, based on the LC50 of 0.117 mg/L from the short-term fish toxicity study and based on the log Kow of 3.191 which is above the threshold value of log Kow 3.0 which triggers chronic aquatic toxicity classification.