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EC number: 203-312-7
CAS number: 105-59-9
to fish: With high probability acutely not harmful to fish
Two acute fish studies were
performed according to German Industrial Standards DIN 38412, part 15
using Leuciscus idus as test species (BASF AG, 1990, report no.
10F0990/885214; BASF AG, 1987, report no. 10F0333/875143). The results
indicate that the test substance is probably acutely not harmful to
fish. The 96-hour LC50 was determined to be >1000 and <2200 mg/L for not
neutralized test solutions. In pelagic toxicity testing a pH of 6.5 to
9.0 is generally accepted (REACH Guidance, R.7B). This value was
exceeded in the initial phase of all test item solutions. The pH
remained above the critical value of pH 9.0 in the test item solutions
of >= 2150 mg/L, which could have caused the high mortality in these
test solutions. It should be noted that the mortality was not reduced
after pH-adjustment of the highest concentration level (10000 mg/l).
However, mortality was delayed. The observed mortalities were at least
partly due to the pH-shift in the higher test item concentrations.
An additional acute toxicity
study using juvenile sheepshead minnows in a semi-static approach
resulted in a 96-h LC50 of >1000 mg/L, therefore demonstrating
comparable endpoints between freshwater and marine fish species. The
test solutions were not neutralised prior to use (BASF AG, 2002; report
to fish: A long-term study on fish was waived based on REACH Annex XI,
chapter 3 (SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING)
According to REACH Annex XI,
chapter 3 (SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING), testing in
accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance
with Annex IX and Annex X may be omitted, based on the exposure
scenario(s) developed in the Chemical Safety Report. For
2,2'-methyliminodiethanol there is a risk assessment available and
submitted with the registration dossier, which includes all life cycle
steps of the substance. This risk assessment demonstrates, taking into
account the appropriate safety factors, the safe use of the substance
throughout its entire life cycle. For none of the protection goals, the
use of the substance creates an unacceptable risk. The resulting RCR
determined for all compartments demonstrate no significant exposure in
all scenarios of the manufacture and all identified uses as referred to
in Annex VI section 3.5. with a maximum RCR of 0.02. Therefore, it is
concluded that 2,2'-methyliminodiethanol does not pose a risk to the
to aquatic invertebrates: With high probability acutely not harmful to
freshwater invertebrates. However, the substance is acutely harmful to
The 48 -h EC50 based on
mobility was determined to be 233 mg a.i./L and was based on nominal
test item concentrations. The test solutions were not neutralised and
the pH measured at the highest test item concentration of 500 mg/L was
9.67 at test initiation. Therefore, immobilisation might have been
caused by the high pH.
In two additional BASF
studies the toxicity of the test substance on the marine copepod Acartia
tonsa was tested. One study was performed according to ISO 14669 as an
acute toxicity study over a period of 48 h, while the other study was
performed similar to ISO 14669 but with an extension of the study period
to 96 h. In addition, the effects on reproduction were measured. As the
exposure period is too short compared to the requirements of a
reproduction study with invertebrates (exposure starting with neonates,
at least 3 broods), the data on reproduction were ignored. The basic
setup of both studies was similar, nevertheless, while the acute
toxicity test used 8 -d old copepodids of undetermined sex, the
reproduction study was performed with 12 -d old adult females. The
number of test animals in the studies did not follow the ISO 14669. The
ISO prescribes at least 20 animals per concentration while in both
studies only 10 animals per test concentration were used. Therefore, the
results on the acute toxicity to marine invertebrates are possibly less
In the acute toxicity test,
the 48 -h LC50 was determined to be 45 mg/L, indicating that the test
substance is acutely harmful to marine invertebrate species. The animals
in the reproduction test showed a lower sensitivity (48 -h LC50 > 100
mg/L; 96 -h LC50 > 100 mg/L). The deviation in sensitivity could be
caused by the difference in age or sex of the test animals. In addition,
this could also mirror a natural variation in sensitivity.
to aquatic invertebrates: The 21 -d NOEC was determined to be 13.9 mg/L
(BASF SE, 2021)
The assessment was performed
with the QSAR Toolbox v4.4 calculation model. The 21 -d NOEC was
determined to be 13.9 mg/L (BASF SE, 2021). The substance was within the
applicability domain of the model. The calculation was performed with
the trend analysis method and the substance was within the applicability
domain of the calculation models.
Overall, it can be
concluded, that that long-term effects are not to be expected.
Furthermore, a 96 -hour
reproduction test on the marine copepod Acartia tonsa was performed (TNO
Chemistry, 2002). The 96 -h NOEC was determined to be >= 100 mg/L. The
96 -h LC50 for parental mortality was > 100 mg/L. Although this study
aimed to test the effect of MDEA on Acartia tonsa, there are several
shortcomings of the test design to yield valid information on
reproduction. A valid reproduction test should start with the exposure
of newly hatched larvae, which should have sufficient time to reach
adulthood and produce 2 to 3 broods of offspring in the control assays.
As this study used 12 -d old females and information on the number of
broods is missing, information regarding reproduction should not be
considered in the risk assessment of MDEA. The data on mortality are
discussed in IUCLID Ch. 6.1.3 Short-term toxicity to aquatic
Toxicity to aquatic
algae and cyanobacteria: With high probability acutely not harmful to
The key study was performed
with Demodesmus subspicatus. It resulted in an EC50 based on the growth
rate of > 100 mg/L (statistical evaluation of the measured fluorescence
data resulted in an extrapolated ErC50 of 176 mg/L; BASF AG, 1988,
report no. 2/0518/88). The 72h ErC10 was 19 mg/L. Another study by BASF
AG using Desmodesmus subspicatus was performed as a range finding study
which was not conducted according to current guidelines (deviations for
example spacing factor, concentration range tested etc.). Further, the
test results were not statistically evaluated and the EC50 of 45.2 mg/L
refers to fluorescence values. Hence, this range finding test was
A study on the marine alga
Skeletonema costata resulted in a 72 -h ErC50 of 410 mg/L and a 72 -h
ErC10 of 89 mg/L (BASF AG, 2002, report no. V2489/04). This result is
supported by Eide-Haugmo et al. (2009) who performed a study with the
same species. The 72 -h ErC50 was determined to be 141 mg/L.
It can be concluded that the
substance is with high probability not acutely harmful to algae in
freshwater and marine systems.
microorganisms: The inhibition of the degradation activity of activated
sludge is not anticipated when introduced in appropriate low
Two short term respiration
inhibition tests conducted by BASF (1988, 1993) demonstrate the effect
on domestic and industrial activated sludge. The EC20 values were > 1000
mg/L in both studies. In a study exposing Pseudomonas putida to not
neutralised test solutions an EC10 of 274 mg/L was observed.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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