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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.208 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.021 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
11.51 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:
183.71 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

OECD Guideline-conform studies have been conducted in order to evaluate the acute toxicity of GALDEN LMW to algae, aquatic invertebrates and fishes. All the studies have been performed under GLP, according to OECD guidelines. The product tends to volatilize quickly from water to the gaseous compartment, therefore the studies were designed in order to reduce the loss for volatilization. In spite of this, a high decrease in test item concentration in water has been observed during the exposure period.  In all the studies no biological effects have been observed at the maximum concentration achievable and therefore GALDEN LMW is not acutely toxic to aquatic organisms.

No reliable aquatic long term studies suitable for hazard assessment are available.

Because of the volatilization of GALDEN LMW, the environmental compartment of distribution is expected to be the atmosphere. According to the environmental assessment, distribution in water, sediment and soil is expected to be negligible and therefore further ecotoxicological studies on sediment and terrestrial organisms are not considered scientifically relevant.

Conclusion on classification

According to reliable short term studies conducted on fish, invertebrates and algae GALDEN LMW is not acutely toxic to aquatic organisms.

GALDEN LMW is not ready biodegradable, it has a partition coefficient Log Kow equal to 5.58 and it is poorly soluble in water, basing on these parameters it fulfills the criteria to be classified in Aquatic Chronic Category 4 according to CLP and GHS criteria. Although GALDEN LMW is not expected to distribute significantly into water compartment and therefore exposure of aquatic organism is considered negligible, at the moment no reliable long-term studies are available for concluding on hazard assessment following long-term exposure.