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EC number: 203-312-7
CAS number: 105-59-9
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
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
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