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EC number: 600-519-8
CAS number: 1040873-93-5
1: Results of the Preliminary Range-finding Test
(100 mg/L nominal)
Average of cell number at 72 hours (x 10^4cells/mL)
Growth Rates (μ) [0-72h]
% Inhibition of μ [0-72h]
Yield (Y) [0-72h]
% Inhibition of Y [0-72h]
Water accommodated fraction
Validity of the Test
- The cell density in the control cultures increased by a factor of
58.00 within 72 hours. This corresponds to a specific growth rate of
- The mean coefficient of variation (CV) for section-by-section specific
growth rates (days 0-1, 1-2 and 2-3, for 72 h-tests) in the control
cultures did not exceed 35 %
- CV for section-by-section growth rate day 0-1: 24.79 %
- CV for section-by-section growth rate day 1-2: 14.08 %
- CV for section-by-section growth rate day 2-3: 5.28 %
The mean coefficient of variation for section-by-section specific growth
rates: 14.72 %.
- The coefficient of variation of average specific growth rates during
the whole test period (day 0-3) in the control cultures was 3.57 %.
All validity criteria were met, therefore the study can be considered as
One test concentration at saturation
(equivalent to 100 mg/L nominal concentration) and a concurrent control
was tested in the main experiment. The concentration of the test item
was analytically determined at the start and at the end of the test.
Measured test item concentration was < LOD (Limit of Detection) over the
test period of 72 hours. Therefore the biological results are based on
the nominal and on the analytical method’s LOD, according to ECHA
Guidance 2017, Chapter R.7b.
Table 2: Concentrations measured during the
Nominal concentration (mg/L)
Start (May 14, 2019)
End (May 17, 2019)
Mean of the measured concentrations (mg/L) (n=6)
Measured concentration in % of the nominal
LOD: 0.1 mg/L
The effect of the test item Blue Sema on the
growth of a unicellular green algal species was determined in a growth
inhibition study according to OECD guideline 201 and EU Method C.3.
Exponentially growing cultures of Raphidocelis subcapitata were exposed
to the saturation concentration of the test item (equivalent to 100 mg/L
nominal concentration) in a limit test over a period of 72 hours.
Because of low solubility of the test item, test solution was prepared
by utilizing the water accommodated fraction (WAF) approach. For
determination of the test item concentration, samples were taken from
the test item treated group and control at the start and end of the
test. The test item concentration was determined using UV/VIS
spectrophotometric method. Measured test item concentration was < LOD
(Limit of Detection) over the test period of 72 hours, therefore the
biological results are based on the nominal test concentration and the
LOD, in line with ECHA 2017.
The results obtained in this study showed that the test item Blue Sema
had not any significant toxic effects on the test system. The 72-h NOEC
was determined to be 0.1 mg/L (Limit of detection, nominal 100 mg/L).
The 72-h LOEC was determined to be > 0.1 mg/L (Limit of detection,
nominal > 100 mg/L). All validity criteria were met.
In this 72-hour growth inhibition study on
algae (Raphidocelis subcapitata), the obtained results showed that the
test item had not any significant toxic effects on the test system.
The 72-h NOEC was determined to be 0.1 mg/L
(Limit of detection, nominal 100 mg/L).
The 72-h LOEC was determined to be > 0.1
mg/L (Limit of detection, nominal > 100 mg/L).
All validity criteria were met. The results
are based on nominal test item concentration and the LOD, in line with
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