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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.013 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.13 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/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:
1.034 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.103 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:
0.199 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

As no long term aquatic toxicity data was available, all PNECaqua values (freshwater, marine and intermittent releases) were calculated using the lowest available EC50 from the acute aquatic toxicity data performed on the three relevant trophic levels. The lowest EC50, 13 mg/L, was derived from the key short-term toxicity to aquatic invertebrates study. The appropriate PNECs were derived using the relevant assessment factors listed in Guidance on Information Requirements and Chemical Safety Assessment Chapter R.10.

The PNECstp value was based upon the NOEC derived from the key ready biodegradability study. The study was performed using a fresh culture of activated sludge from a biological waste water treatment plant treating predominantly domestic sewage and is therefore considered to be directly comparable to environmental effects.

As no terrestrial compartment data was available, the PNECsediment (freshwater and marine water) and PNECsoil was derived using the equilibrium partitioning method as detailed in Guidance on Information Requirements and Chemical Safety Assessment Chapter R.10.

The PNECoral value was based upon the key repeat-dose (oral) toxicity study with a reported NOAEL value of 150mg/kg bw/day from this 28 day study.

Conclusion on classification

In accordance with Regulation EC 1272/2008 and Directive 67/548/EEC, the substance does not meet the criteria for classification for

either acute or chronic aquatic hazards. Although E(L)C50 values below 100 mg/L were observed in the ecotoxicological studies, none were below 13 mg/L placing the substance outside the criteria for acute aquatic toxicity classification. As the substance has an experimentally derived partition coefficient of 2.7 and it is rapidly biodegradable it does not fall within the criteria for chronic aquatic toxicity.