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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.039 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:
0.196 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Adequate chronic toxicity data are not available for Leucophor 1111X, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available.

The key values chosen for Chemical Safety Assessment concerning the aquatic compartment are the following:

- for the short-term toxicity to fish the LC50 (96h) resulted to be greater than 100 mg/l

- for short-term toxicity to aquatic invertebrates the EC50 (48h) resulted to be greater than 100 mg/l

- for toxicity to aquatic algae and cyanobacteria the ECb50 (72 h) is 93 mg/l, ECr50 (72h) greater than 100 mg/l and the NOEC (72h) was identified to be 22 mg/l (both biomass and growth rate)

- for toxicity to microorganisms the NOEC (3h) was determined to be equal/higher than 1000 mg/l

The outcomes of the tests performed on the three trophic levels suggest that alga is the most impacted species.

In order to derive the PNEC water (both freshwater and marine water), the short-term effect level of the most sensitive species was chosen. Thus, the EC50 related to the algae biomass has been selected.

Conclusion on classification

Adequate chronic toxicity data are not available; Leucophor 1111X is not readily biodegradable and has a negative log kow.

On the basis of the short-term toxicity data on the three trophic levels (details above), Leucophor 1111X does not meet the criteria to be classified as hazard to the aquatic environment, according to the CLP Regulation (EC 1272/2008).