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EC number: 942-932-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-17 to 2018-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- adopted 23 March 2006 (Annex 5 corrected 28 July 2011)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- 01 March 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 10.0, 3.70 1.37, 0.51, 0.19 mg/L.
- Sampling method: For determination of the test item concentrations samples were taken from each test concentration and from the control at the start of the test and from each test concentrations after 24 h, 48 h and at the end of the test. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The test solutions used in the test were prepared by mechanical dispersion. For preparation of the test solutions a stock solution (10 mg/L) was first prepared by dissolving an amount of 0.01 g test item into 1000 mL test medium (OECD medium). This stock solution was placed into an ultrasonic bath for 10 min. The test solutions of subsequent lower test concentrations were prepared by appropriate diluting of this stock solution.
After the formulation procedure algal cells were immediately introduced into the test solutions.
Untreated control ran parallel in the test. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Raphidocelis subcapitata (formerly known as Pseudokirchneriella subcapita and Selenastrum capricornutum) (Printz-Starr).
- Source: The algae were supplied by the SAG: Collection of Algal Cultures, Inst. Plant Physiology, University of Göttingen, Untere Karspüle 2, D-37073 Göttingen, Germany.
- Method of cultivation: The stock cultures are small algal cultures that are regularly planted on agar. These are transferred to fresh medium at least once every two months under standardised conditions according to the test guidelines.
The pre-culture is intended to give an amount of algae suitable for the inoculation of test cultures. The pre-culture was prepared with Algal Mineral Salts Culture Medium, incubated under the conditions of the test and used when still exponentially growing, normally after an incubation period of 2 - 4 days. (The pre-culture was incubated for four days at this test.)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- none
- Hardness:
- no data
- Test temperature:
- 22.4 – 23.2 °C
- pH:
- 7.96 – 8.95
- Dissolved oxygen:
- no data
- Salinity:
- not applicable
- Conductivity:
- no data
- Nominal and measured concentrations:
- Nominal concentrations: 10.0, 3.70 1.37, 0.51, 0.19 mg/L.
Calculated geometric mean concentrations: 6.03, 2.10, 1.04, 0.15 and 0.06 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel (material, size, fill volume): Erlenmeyer flasks of ~250 mL volume with 100 mL test medium.
- Aeration: No
- Initial cells density: 10^4 cells/mL
- Control end cells density: 95.0 × 10^4 cells/mL (mean value) after 72 hours.
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
The test was performed with 2 extra replicates per test concentrations for analytical determinations.
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to OECD guideline
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 24 hours illumination.
- Light intensity and quality: Average light intensity of 8026 lux, which was ensured with fluorescent lamps (with a spectral range of 400 - 700 nm).
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: The cell numbers were determined at 24, 48 and 72 hours after starting the test by manual cell counting using a microscope with counting chamber.
- Other: The morphological changes of algal cells compared to the control were examined at 24, 48 and 72 hours after starting the test using a microscope.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.7
- Range finding study: A non-GLP preliminary test was performed at the nominal concentrations of 100, 10, 1, 0.1, and 0.01 mg/L. Untreated control ran parallel in the test. Algal cells were exposed to each concentration of the test item plus control, for 72 hours. The test was performed with two replicates in treatment groups and three replicates in the control. For preparation of test solution 0.04 g test item was dissolved in 400 mL OECD medium using 10 min ultrasonic dispersion. The test solutions of subsequent lower test concentrations were prepared by appropriate diluting of this stock solution. In the preliminary range-finding test 100% inhibition was determined in the two highest test concentrations.
- Results used to determine the conditions for the definitive study: Based on a non-GLP Preliminary Range-Finding Test (see above), five test concentrations in a geometric series (with a spacing factor of 2.7) were used in the main test. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.94 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% conf. limits: 0.814 – 1.028
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 1.07 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% conf. limits: 0.976 – 1.158
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.33 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% conf. limits: 1.237 – 1.455
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.65 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% conf. limits: 0.426 – 0.761
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 0.78 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% cong. limits: 0.626 – 0.869
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.04 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% conf. limits: 0.963 – 1.121
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.15 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and biomass
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 1.04 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and biomass
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities: No
- Shape of the Algal Cells: No morphological abnormalities were observed in the control and in the concentrations of 0.06 and 0.15 mg/L (measured) during the test. Some swollen and thin cells were observed together with the normal cells in the concentration of 1.04 mg/L (measured) at the 48-h and 72-h observation period. In the concentrations of 2.10 and 6.03 mg/L (measured) thin cells were observed and in the highest concentration (in two replicates) the shape of algal cells could not be evaluated at 72 hours due to the absence of cells. - Results with reference substance (positive control):
- The 72h ErC50: 0.82 mg/L, (95 % confidence limits: 0.57 – 1.25 mg/L)
The 72h EyC50: 0.51 mg/L, (95 % confidence limits: 0.45 – 0.57 mg/L) - Reported statistics and error estimates:
- For the determination of the LOEC and NOEC, Dunnett T3 test (α = 0.05) was used and for the determination of the ECx values Probit analysis was used (by SPSS software).
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this 72-h algal growth inhibition test with Raphidocelis subcapitata, the obtained results showed that the test item MIKP had significant toxic effects on the growth of Raphidocelis subcapitata.
The 72-h EC10, EC20, EC50 for growth rate were determined to be 0.94, 1.07 and 1.33 mg/L, respectively. The 72-h EC10, EC20, EC50 for yield were determined to be 0.65, 0.78 and 1.04 mg/L, respectively. The LOEC values based on growth rate and yield were determined to be 1.04 mg/L. The 72-h NOEC for growth rate and yield was determined to be 0.15 mg/L. The results are based on measured geometric mean test item concentrations. - Executive summary:
In a growht inhibition test according to OCCD guideline 201 and EU method C.3, the effect of the test item Methyl-isobutyl-ketone-peroxide (MIKP) on the growth of a unicellular green algal species was evaluated. Exponentially growing cultures of Raphidocelis subcapitata were exposed to the nominal test item concentrations of 10.0, 3.70 1.37, 0.51, 0.19 mg/L under defined conditions. Corresponding calculated geometric mean measured concentrations were: 0.06, 0.15, 1.04, 2.10 and 6.03 mg/L. The algal growth in relation to a control culture was determined over a fixed test period of 72 hours and, thus, over several algal generations. Biological results are based on the measured geometric mean test item concentrations as the analytically measured test item concentrations were not within the range of ± 20 % of the nominal over the test period of 72 hours.
In this 72-h algal growth inhibition test with Raphidocelis subcapitata, the obtained results showed that the test item Methyl-isobutyl-ketone-peroxide (MIKP) had significant toxic effects on the growth of Raphidocelis subcapitata. The 72-h EC10, EC20, EC50 for growth rate were determined to be 0.94, 1.07 and 1.33 mg/L, respectively. The 72-h EC10, EC20, EC50 for yield were determined to be 0.65, 0.78 and 1.04 mg/L, respectively. The LOEC values based on growth rate and yield were determined to be 1.04 mg/L. The 72-h NOEC for growth rate and yield was determined to be 0.15 mg/L. All validity criteria were met. The results are based on measured geometric mean test item concentrations.
Reference
Analytical Results
Five test concentrations in a geometric series (with a spacing factor of 2.7) as a dilution series of a stock solution were investigated in the main test and analysed by HPLC method with UV detection at the start, after 24 h, 48 h and and at the end of the test.
Exposure concentrations were calculated as the geometric mean of the measured concentrations.
Table 1: Calculation of exposure concentrations
Nominal concentrations (mg/L) |
Measured concentration [mg/L] |
Geometric mean [mg/L] |
|||
start |
24 h |
48 h |
end |
||
Control |
not detected |
- |
- |
- |
– |
0.191 |
0.13 |
0.08 |
0.08 |
0.01* |
0.06 |
0.512 |
0.50 |
0.14 |
0.15 |
0.05** |
0.15 |
1.37 |
1.20 |
1.22 |
0.91 |
0.88 |
1.04 |
3.70 |
3.16 |
2.68 |
1.81 |
1.28 |
2.10 |
10.0 |
9.23 |
6.51 |
6.68 |
3.30 |
6.03 |
Remark: LOQ= 0.50 mg/L.
1: Due to the analytical sampling preparation (see Table 1 Appendix 2) at this concentration level the LOQ corresponds to LOQ/20
2: Due to the analytical sampling preparation (see Table 1 Appendix 2) at this concentration level the LOQ corresponds to LOQ/5
* (LOQ/20)/2
** (LOQ/5)/2
The analytically measured test item concentrations were not within the range of ± 20 % of the nominal over the test period of 72 hours.
Description of key information
In an algal growth inhibition test with Raphidocelis subcapitata, the 72-h EC10, EC20, EC50 for growth rate for MIKP were determined to be 0.94, 1.07 and 1.33 mg/L, respectively. The 72-h EC10, EC20, EC50 for yield were determined to be 0.65, 0.78 and 1.04 mg/L, respectively. The LOEC values based on growth rate and yield were determined to be 1.04 mg/L. The 72-h NOEC for growth rate and yield was determined to be 0.15 mg/L. The results are based on measured geometric mean test item concentrations.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 1.33 mg/L
- EC10 or NOEC for freshwater algae:
- 0.94 mg/L
Additional information
In a growth inhibition test according to OCCD guideline 201 and EU method C.3, the effect of the test item Methyl-isobutyl-ketone-peroxide (MIKP) on the growth of a unicellular green algal species was evaluated. Exponentially growing cultures of Raphidocelis subcapitata were exposed to the nominal test item concentrations of 10.0, 3.70 1.37, 0.51, 0.19 mg/L under defined conditions. Corresponding calculated geometric mean measured concentrations were: 0.06, 0.15, 1.04, 2.10 and 6.03 mg/L. The algal growth in relation to a control culture was determined over a fixed test period of 72 hours and, thus, over several algal generations. Biological results are based on the measured geometric mean test item concentrations as the analytically measured test item concentrations were not within the range of ± 20 % of the nominal over the test period of 72 hours.
In this 72-h algal growth inhibition test with Raphidocelis subcapitata, the obtained results showed that the test item Methyl-isobutyl-ketone-peroxide (MIKP) had significant toxic effects on the growth of Raphidocelis subcapitata. The 72-h EC10, EC20, EC50 for growth rate were determined to be 0.94, 1.07 and 1.33 mg/L, respectively. The 72-h EC10, EC20, EC50 for yield were determined to be 0.65, 0.78 and 1.04 mg/L, respectively. The LOEC values based on growth rate and yield were determined to be 1.04 mg/L. The 72-h NOEC for growth rate and yield was determined to be 0.15 mg/L. All validity criteria were met. The results are based on measured geometric mean test item concentrations.
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