Registration Dossier
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EC number: 203-312-7 | CAS number: 105-59-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Additional information
The key study selected for deriving the PNECaquatic freshwater is the acute test on Desmodesmus subspicatus, BASF AG, 1988. For the marine compartment the most sensitive endpoint was the LC50 of 45 mg/L after 48 hours of exposure determined for Acartia tonsa (TNO, 2002). The PNEC for the marine compartment is derived from the NOEC of the freshwater algae test since this was the most sensitive endpoint of all aquatic toxicity tests available. Data on the reproduction test with the marine crustacea (Acartia) is provided, but should not be taken into consideration for the risk assessment due to significant shortcomings of the test design.
With LC50 values of > 1000 mg/L freshwater and marine fishes (BASF AG, 1990 and TNO, 2002, respectively) were less sensitive compared to aquatic invertebrates and algae.
The test substance demonstrated low toxicity to microorganisms and therefore inhibition of the degradation ability of activated sludge is not anticipated when introduced in appropriately low concentrations.
Although supporting chemical analysis was not performed in any of the ecotoxicity studies, the test item concentrations can be assumed to have been stable over the exposure periods of the tests for several reasons:
MDEA is highly soluble in water; therefore, undissolved residues are not to be expected and were also not observed in the tests. In combination with the low vapour pressure (0.0031 hPa at 20 °C, see IUCLID Ch. 4.6) and the low Henry's Law constant (pH 5 to 9: 1.82E-09 to 5.90E-06 Pa m³/mol, see IUCLID Ch. 5.4.2) volatilisation is not to be expected. The low adsorption potential (pH 5 to 8: Koc = 38 to 43, see IUCLID Ch. 5.4.1) indicates that MDEA will not adsorb to the testing equipment or the test animals. Based on the abiotic control of the key biodegradation study, the maximum removal was 6% by day 7 (see IUCLID Ch. 5.2.1, BASF AG, 1993). Although the substance is readily biodegradable, the lag phase in the biodegradation studies was long compared to the exposure periods of the aquatic toxicity tests. In the OECD 301A test (IUCLID Ch. 5.2.1, key study, BASF AG, 1993), the lag phase was > 3 to < 7 days. In seawater, 5% removal was observed after 7d based on BOD (IUCLID Ch. 5.2.1, supp. study, BASF SE, 2011: OECD 306). In the MITI test removal after 28 d was low (7% ThOD, 23 TOC, 25% test material). Regarding the short exposure period (48 to 96 h), a relevant decrease of the test item concentrations (> 20%) is not to be expected.
Based on the properties of MDEA, it can be concluded that the test item concentrations remained within acceptable limits in the ecotoxicity studies.
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