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EC number: 947-384-4
CAS number: -
Table 1: Validity criteria
Criterion from the guideline
Validity criterion fulfilled
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period.
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35%
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata and Desmodesmus subspicatus. For other less frequently tested species, the value should not exceed 10%.
The test substance Sucrose Palmitate Stearate MDT Grade was tested for
toxicity to algae. Three replicates each at concentrations of 6.3, 13,
25, 50, and 100 mg/L of test substance were tested. Negative controls
were also used. After 72 hrs of exposure, none of the test
concentrations showed reduced growth as compared to controls. The 72 -hr
EL50 is therefore > 100 mg/L water accomodated fraction. The 72 -hr
NOELR is >= 100 mg/L.
ErL50 (72 h) > 100 mg/L (nominal, OECD 201)
NOErLR (72 h) ≥ 100 mg/L (nominal, OECD 201)
Two experimental studies are available investigating the toxicity
of the test item to aquatic freshwater algae.
The first study was performed according to OECD 201 (Mitsubishi, 2016).
Pseudokirchneriella subcapitata was exposed to nominal loading rates of
6.3, 13, 25, 50 and 100 mg/L for 72 h. The Water Accommodated Fractions
(WAF) were prepared by adding an appropriate amount of test item to test
medium, followed by intensive stirring (47 h) and a settling period (1
h). Particulates were observed at the top of the 6.3 mg/L solution. The
25, 50, and 100 mg/L solutions were cloudy with particulates on the
surface of the solution. HPLC/MS analysis revealed only a low recovery
of the test item. In the 25 and 100 mg/L loading rate concentrations of
1.69 and 2.56 mg/L was recorded, respectively. In the remaining loading
rates the recovery was below the LOQ (< 1 mg/L). This result reflects
the very low water solubility of the substance and indicates that the
concentration of the test item is in line with the water solubility (<
1.51 mg/L). At the end of exposure after 72 h no effects of the test
item on growth was recorded at any of the loading rates tested resulting
in an ErL50 (72 h) > 100 mg/L and a NOELR (72 h) ≥ 100 mg/L.
The result from the key study was confirmed in one supporting study
(DKS, 2016). This study was performed according to OECD 201 (GLP).
Compared to the key study no chemical analysis of test concentrations
was performed and no loading rate was tested. In this study a test
solution of 100 mg/L was prepared and stirred for 48 h. This solution
was used for testing without further processing (e.g. filtration,
siphoning). In contrast to the key study these test solutions were clear
and colorless and no precipitate was recorded. No effects on growth rate
were observed after 72 h resulting in an EC50 (72 h) > 100 mg/L and a
NOEC (72 h) ≥ 100 mg/L.
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