Results and Validity – Toxicity – SESAMULS® OW
STATISTICS AND RESULTS
Biological Results of the Test Item
The following values were determined:
|NOEC (Growth Rate) 72 h||< 1.0 mg/L||not determinable|
|NOEC (Yield) 72 h||< 1.0 mg/L||not determinable|
|LOEC (Growth Rate) 72 h||1.0 mg/L||not determinable|
|LOEC (Yield) 72 h||1.0 mg/L||not determinable|
|72 h ErC50||10 – 100 mg/L||not determinable|
|72 h ErC50||< 1.0 mg/L||not determinable|
Biological Results of the Reference Study (14070902R301)
The results for the last study with the positive control K2Cr2O7 are presented in the following table. The study was performed under GLP conditions in August 2018.
|Parameter||Value||95%-confidence-interval||Range of interlaboratory test (EU C.3)|
|72h ErC50||0.99 mg/L||0.94 – 1.1 mg/L||0.60 – 1.03 mg/L|
|72h EyC50||0.55 mg/L||0.52 – 0.58 mg/L||none stated|
The cell concentration in the control should increase by a factor of at least 16 within 72h.
Daily Growth Rates
Mean coefficient of variation of daily growth rates should be 35% at the most. Coefficient of variation of average growth rate during the whole test period should be 7% at the most.
Values and assessment
The daily growth rates of the controls were calculated. Means, standard deviations and coefficients of variation were determined. Values and assessment can be found in the following tables.
|Growth rates||days 0 – 1||days 1 – 2||days 2 – 3||CV of sectional daily growth rates||days 0 – 3|
CV = Coefficient of Variation
|Parameter||Validity criteria||Observed value||Assessment|
|Increase factor biomass||factor 16 in 72 h||100||Valid|
|Mean coefficient of variation of daily growth rates||max. 35%||16||Valid|
|Coefficient of variation of average growth rate during the whole test period||max. 7%||4||Valid|
During the test exponential growth was given.
Change of pH
The pH of the control should not fluctuate by more than 1.5 units. The change was 0.8 units.