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EC number: 211-334-3
CAS number: 638-38-0
general, all relevant experimental results in this chapter were derived
from studies on aquatic organisms, where the documentation and given
results indicate that the study was well-performed and satisfies general
scientific requirements. So all relevant studies were classified as
reliable with restrictions and consequently, the results can considered
to be reliable and used for classification and further risk assessment.
LC50 values in a 96 h acute toxicity test in Colisa fasciatus with
the read-across substance MnSO4 were determined to be 2850 mg/L (Agrawal
SJ, 1980) and 3230 mg/L (Nath K, 1987), respectively, in US guideline
studies. Therefore, these values can be considered as reliable as can be
used for classification and further assessment. Since these studies were
with the same species and the values are of the same magnitude, the LC50
value of manganese acetate can be estimated within the
Weight-of-evidence approach as 3 g/L. This value does not trigger the
classification of Manganese acetate, neither according to regulation
1272/2008/EC nor directive 67/548/EEC. Additionally, the available
supporting studies further confirm the conclusion not to classify
Manganese (II) acetate. With a LC50 value of 3 g/L, which is more than
one magnitude above the limit for classification according 1272/2008/EC
was set as </= 100 mg/L (LC50, 96h). Therefore, no further information
on long-term toxicity was needed to be obtained because no extremely
lower long-term value can be expected which is supported by that fact
that manganese (II) acetate has no potential for bioaccumulation.
the characterization of the possible adverse effects in invertebrates,
the existing data suggest to follow the approach of assessing the two
ions individually and perform the subsequent risk assessment, i.e.
deriving PNECs, based on the more distressing ion.
the acetate anion, an EC50 value of 132 µl/L (approx. 132 mg/L) after 48
h was found in Artemia nauplii (Espiritu EQ, 1995), and an EC50 (48 h)
of 65 ± 9 µl/L, corresponding to approx. 65 mg/L, was found in Daphnids.
Taking into account the sensitivity of daphnids towards acidic
conditions and the fact, that the pH was not adjusted in both
experiments, the EC50 value would be much higher if pH was adjusted,
preferably above 100 mg/L as already shown in Artemia nauplii.
Additionally, it can be concluded from the magnitude of the observed
EC50s, the NOEC in a chronic study will be above 1 mg/L. Acetic acid is
part of many metabolic pathways, has an ionic structure and low
molecular weight, so it can be concluded, that it has a low BCF and no
toxic metabolites will be formed. In Summary, the observed EC50 values
obtained from acetic acid and subsequent conclusions do not trigger
assessing the toxicity of the manganese (II) cation, most studies on the
read across substances exhibited EC50, LC50, LC0 and LC100 values above
100 mg/L on several timepoints up to 7 d (see IUCLID section 6.1.3)
high EC50, LC50, LC0 and LC100 values determined in aquatic invertebrate
studies covering this endpoint do not reasonable indicate the necessity
to perform long-term toxicity test because the NOEC which would be
determined in these test is expected to be very high, too, i.e. much
higher than the boundary value of 1 mg/L, which is especially supported
by the LC0 values after 7 days: Carinogammarus Roeselii, LC0 = 45 mg/L;
Tubifex tubifex, LC0 = 600 mg/L; Chironomus thummy larvae, LC0 = 750
mg/L; Anabolia nervosa larvae, LC0 = 3000 mg/L (Schweiger G, 1956).
Additionally, the manganese (II) cation as an inorganic ion is neither
expected to have a BCF≥500
nor a logKow≥4.
Taking into account the classification criteria as set out in regulation
1272/2008/EC, Mn2+ does not trigger classification, and consequently,
Manganese (II) acetate does not need to be classified as well as no
further long-term testing is indicated.
the key value (freshwater invertebrates) for further risk assessment the
LC0 (7d) of 45 mg/L in Carinogammarus Roeselii was chosen. Since the
determined EC50, LC50, LC0 and LC100 values do not indicate further
long-term testing, the possibly best surrogate for a chronic NOAEL
should be chosen. 7 days is the longest test duration available and the
value LC0 indicates that no animal was affected, which corresponds very
well to a No Observed Adverse Effects Level. Furthermore, Carinogammarus
Roeselii was determined to be the most sensitive species. Consequently,
when performing the further assessment of Manganese (II) acetate
toxicity and deriving PNECs, it must be taken into account that 45 mg/L
is not the usually used EC50 (48 h) value but the LC0 (7 d) value and
subsequently lower assessment factors should be applied.
EC50 for marine water invertebrates of 132 mg/L was chosen on the basis
of the effects of Acetic acid on Artemia nauplii, although it is most
likely to be caused by changes in the pH, because it is the only value
available for marine water invertebrates.
assessing the toxicity of Manganese (II) acetate in aquatic algae and
cyanobacteria, the relevant EC50 and EC10 values were chosen from the
study in Plectonema boryanum on the Manganese cation (Singh, 1975).
Since P. boryanum is the more sensitive species, and the acetate anion
does not pose any risk to aquatic algae, these values are used for
classification: An EC50 value of approx. 0.2 mM Mn2+, which corresponds
to 34.5 mg/ Manganese (II) acetate, was determined. Taking into account
that Manganese (II) acetate as an inorganic salt has no potential for
bioaccumulation and no effects were observed at the hypothetic
concentration of 5.1 mg/L Mn(acO)2 after 10 days in this experiment,
Manganese (II) acetate does not need to be classified according to
regulation 1272/2008/EC. So, the determined EC10 value of 5.1 mg/L Mn(acO)2
can serve as a NOEL for further risk assessment.
general, algae or other aquatic organisms serve as model organisms in
order simulate actual environmental conditions and how a testing
substance could affect them. Testing only on standard species can only
give a limited insight in real conditions, and every testing on
additional species, such as aquatic plants or higher tier mesocosm
studies, could enlarge the insight, how a substance would affect the
environment. So every testing on other aquatic plants or aquatic
organisms in general would decrease the possible uncertainties due to
extrapolation from only one species and hence, can serve to support the
results from algae or other aquatic organisms toxicity testing and to
lower any assessment factor.
studies, in addition to the non-standard organisms already included in
IUCLID sections 6.1.1 and 6.1.3, are available to support the results
from the testing on algae, fish and invertebrates and the conclusion
that no classification of Manganese (II) acetate is required.
study on Duckweed (Lemna minor) (Wang S, 1986) revealed a growth
inhibition of 50% after 4 days at a concentration of 96 mg/L, corrected
for Manganese (II) acetate and based on the increase of their front
number. Two studies on aquatic protozoae, i.e. Tetrahymena pyriformis
(Bogaerts P, 1998) with an IC50 (9h) of 650.6 mg/L, corrected for
Manganese (II) acetate and based on growth inhibition, and Spirostomum
ambiguum (Nalecz-Jawecki G, 1998) with an LC50 (48h) of 452.4 mg/L,
corrected for Manganese (II) acetate and based on growth mortality, are
the results from these studies broaden additionally the spectrum of
aquatic organisms and, as additional models, allow a deeper insight in
the expectable effects of the test substance on the aquatic environment,
these results should be also taken into account when assessing the
possible hazard of Manganese (II) acetate to the aquatic environment and
consequently the need for classification.
the test durations and endpoints of these mentioned studies are not
equal enough to allow one to plot them as a species sensitivity
distribution, it can be clearly stated that the available endpoint for
algae toxicity on Plectonema boryanum, i.e. an EC50 value of approx.
34.5 mg/L and an EC10 value of 5.1 mg/L Manganese (II) acetate after 10
days, can considered to be the most sensitive endpoint in the most
sensitive species, and should therefore be taken into account when
assessing the possible hazard of Manganese (II) acetate to the aquatic
summary, no classification of Manganese (II) acetate as hazardous to the
aquatic environment is needed.
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