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EC number: 938-645-3
CAS number: 1689515-39-6
Table 1 Measured concentrations
(mg test item/L)
(mg test item/L)*
(mg test item/L)*
(mg test item/L)
% of nominal*
Mean value (n=4):
Overall mean value (n=20)
The tabulated results
represent rounded results calculated on the exact raw data
LOD: Limit of Detection
= 2 mg test item/L
n.a.: not applicable;
RSD: Relative Standard Deviation; D.F.: Dilution factor
The values are below 80% of the nominal concentration, however, the
nominal values were used for calculating the effect concentrations. This
was done because the NOEC is 120 mg test item/L and the recoveries in
the higher concentration range show nominal recoveries in the freshly
prepared and aged test samples.
Table 2 Influence of Miranol BM Conc. on the mobility of Daphnia magna
Nominal concentration (mg test item/L)
No. of Daphnia tested
No. of immobilized Daphnia
% of immobilized Daphnia
After 24 h
After 48 h
A short term toxicity test was performed, according to OECD guideline
202 and GLP principles, to assess the potential of Miranol BM Conc to
induce immobility in Daphnia magna. The test item was corrected
for the solid fraction and added to the medium at nominal concentrations
of 11.3, 24.7, 54.4, 120 and 263 mg test item/L (corresponding to 4.3,
9.4, 20.7, 45.5 and 100 mg solids/L). Twenty daphnia per concentration
and a blank control, divided over four vessels, were exposed to the test
solutions for 48 hours. The number of immobilised daphnids after 24
hours and 48 hours was recorded. Duplicate samples for analysis were
taken at t=0 and t=48 to determine actual exposure concentrations.
Analysis showed that the test concentrations remained 79 -97% of nominal
test concentrations. The effect concentrations were based on nominal
test concentrations since the measured concentration was below 80% of
initial in the lowest concentration only and no effects were seen at
Only in the highest test concentration an effect was observed. In the
other test concentrations no daphnids became immobilised while in the
highest test concentration 100% of the introduced daphnids became
immobilised. The 48h-EC50 of Miranol BM Conc. was determined to be 177
mg/L (67.3 mg solids/L). All validity criteria were met and the study
was considered to be valid.
Two studies with the registered substance are available, as well as 5
older studies with a substance analogue. The EC50 values for the
registered substance are 67.4 mg solids/L and >100 mg solids/L.
Comparing the older data with the results of the daphnia studies
performed in 2017 show that the newer studies give a higher EC50 value.
This is expected to be related to the degree of purity of the substances
tested. The results from the acute studies with daphnids are considered
more relevant for read across than the older reported EC50 values. See
the read-across report in Section 13 for full details of the read-across
rationale. The lowest
EC50 value obtained with the registered substance is used as a
worst-case key value for chemical safety assessment.
The 48h-EC50 for Miranol BM Conc towards Daphnia magna was 177 mg/L
(67.3 mg solids/L).
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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