Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
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:
50 122 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
5 012 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:
9 992 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

The MDI category members do not show acute toxicity to aquatic organisms at their limit of solubility. Therefore, the category members do not meet the criteria for classification as acutely toxic to the aquatic environment under the EU CLP regulation.

Chronic aquatic toxicity data for algae and Daphnia are available for members of the MDI category. These data would not result in a chronic classification under CLP as no toxicity was observed at the highest nominal loading rate in the studies.  A harmonised classification of Aquatic Chronic 4 has been applied to the substances with EC numbers 406-690-3, 406-530-2, 406-370-3. This is a safety net classification assigned to poorly soluble substances which are not readily biodegradable and do not exhibit acute toxicity at the limit of solubility. However, for the MDI category, the substance Reaction product of 4,4'-methylenediphenyl diisocyanate and amines, coco alkyl has been tested for toxicity to aquatic algae and in a long-term Daphnia study. This substance was selected for testing due to it being potentially the most water-soluble substance in the category (although still poorly soluble) and as it contains a range of structures from C6 to C18, bracketing the structures in the category. Based on the study results no effects were observed at highest nominal loading rate, considered to be the limit of solubility of the test item. As chronic data are available, and demonstrate no toxicity at the limit of solubility, an Aquatic Chronic 4 classification is not required for substances within the MDI category.

Additionally, high temperature stability indicates that the grease thickener structure is robust and resistant to diffusion out of the oil. Dissolution of grease thickeners from grease into water is very unlikely as the thickeners are poorly water soluble and the thickeners are embedded in the hydrophobic grease matrix and thus unlikely to leach out, as detailed in the additional information on environmental fate section of this dossier. The screening ecotoxicity data (using SPME-GC and the in vitro Microtox assay), confirm a lack of toxicity of the greases. Therefore, an aquatic chronic classification is not required.