Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-17 to 2018-04-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 13th April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.0256, 0.064, 0.16, 0.4, 1.0, 2.5, 6.25 and 15.6 mg/L
- Sampling method: For determination of the test item concentrations, samples were taken from each test concentration at the start and at the end of each water renewal period and from the controls at the start of the renewal periods. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The test solutions used in the test were prepared by mechanical dispersion without using of any solubilising agent. After the formulation procedure the test animals were immediately introduced into the test solutions.
Main Experiment:
For preparation of test solutions (at each renewal period) a stock solution of 10 mg/L (nominal concentration) was first prepared by dissolving an amount of 0.006 g test item in 600 mL ISO medium using 10 min ultrasonic bath. The test solutions of subsequent concentrations were prepared by appropriate dilution of this stock solution.
Complementary Experiment:
For preparation of test solutions (at each renewal period) a stock solution of 15.6 mg/L (nominal concentration) was first prepared by dissolving an amount of 0.0094 g (at the start of the test) and 0.0096 g (at the first renewal period) test item in 600 mL ISO medium using ultrasonic bath. The test solutions of subsequent concentrations were prepared by appropriate dilution of this stock solution. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: Daphnia magna (Straus)
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Age of parental stock: Less than 24 hours old
- Sex: Female
- Feeding during test: None
ACCLIMATION
Test animals were bred under similar conditions as that used during the exposure period, therefore additional acclimatisation before the test was not necessary.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 249 mg/L (as CaCO3)
- Test temperature:
- 19.8 – 20.8 °C (measured in the test vessels)
19.4 – 21.7 °C (within the climate chamber ) - pH:
- 7.95 – 8.20
- Dissolved oxygen:
- 7.80 – 8.42 mg/L
- Salinity:
- not applicable
- Conductivity:
- no data
- Nominal and measured concentrations:
- Main Experiment:
Nominal concentrations: 0.0256, 0.064, 0.16, 0.4 and 1.0 mg/L
Calculated geometric mean measured concentrations: 0.03, 0.04, 0.09, 0.21 and 0.36 mg/L.
Complementary Experiment:
Nominal concentrations: 2.5, 6.25 and 15.6 mg/L
Calculated geometric mean measured concentrations: 2.00, 5.11 and 14.04 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers of approximately 100 mL test medium
- Renewal rate of test solution (frequency/flow rate): 24-h renewal periods
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to OECD guideline.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light (artificial illumination) and 8 hours darkness
EFFECT PARAMETERS MEASURED:
The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile.
RANGE-FINDING STUDY:
- Test concentrations (Range-Finding Test): A non-GLP preliminary test was performed at the nominal concentations of 100, 10, 1, 0.1, and 0.01 mg/L in order to check the toxicity of the test item on the daphnids.
- Results used to determine the conditions for the definitive study:
In the Preliminary Range-Finding Test ten daphnids in the test concentrations and control were exposed for 48 hours (respectively). 0/10 daphnids were immobilised at the end of the test in the three highest test item concentrations (1, 10, 100 mg/L) and no immobilised daphnids were observed in the two lowest test concentrations (0.1 and 0.01 mg/L).
Based on the results of the non-GLP Preliminary Range-Finding Test five test concentrations in a geometric series (with a spacing factor of 2.5) were used in the main test. As just 5% immobility was observed in the test concentrations of 0.064 and 1 mg/L in this test the toxicity of test item was further investigated at higher concentrations in a complementary experiment to determine the EC50 value. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 2.19 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % conf. limits: 1.152 – 2.930
- Duration:
- 48 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- 2.98 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % conf. limits: 2.151 – 3.726
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 4.48 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % conf. limits: 3.729 – 5.581
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 5.11 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The 24h EC50: 1.53 mg/L (95% conf. limits: 1.30 – 1.78 mg/L)
- Reported statistics and error estimates:
- The 48-h ECx values were calculated by Probit analysis using SPSS software. The ECx values were calculated from the results of the following concentrations (nominal): 0.16, 0.4, 1.0, 2.5, 6.25 and 15.6 mg/L. The concentrations of 0.0256, 0.064 mg/L were excluded from the statistical evaluation as these concentration levels were not validated.
For the determination of the LOEC and NOEC, Dunnett t-Test (2-sided, α= 0.05) was used. - Validity criteria fulfilled:
- yes
- Conclusions:
- In this 48-hour acute toxicity test on Daphnia magna, the obtained results showed that the test item Methyl-isobutyl-ketone-peroxide (MIKP) had significant toxic effects on the mobility of Daphnia. The 48-h EC50 value was determined to be 4.48 mg/L. The 48-h NOEC was determined to be 2.00 mg/L and the 48-h LOEC was determined to be 5.11 mg/L. The results are based on measured test item concentrations.
- Executive summary:
The influence of the test item Methyl-isobutyl-ketone-peroxide (MIKP) on the mobility and survival of Daphnia magna was determined in an acute toxicity study according to OECD guideline 202 and EU method C.2.
Young Daphnia were exposed to aqueous test medium containing the test item at concentrations of 0.0256, 0.064, 0.16, 0.4 and 1.0 mg/L. The percentage of Daphnia being no longer capable of swimming at the end of the test or being dead was recorded for each test concentration. As just 5% immobility was observed in the test concentrations of 0.064 and 1 mg/L in this test the toxicity of test item was further investigated at higher concentrations of 2.5, 6.25 and 15.6 mg/L in a complementary experiment to determine the EC50 value.
The measured concentrations deviated more than 20 % from the nominal during the experiment therefore the geometric mean of the concentrations measured at the start and end of the water renewal periods were calculated to determine exposure concentrations. The corresponding calculated geometric mean test item concentrations were: 0.03, 0.04, 0.09, 0.21, 0.36, 2.00, 5.11 and 14.04 mg/L.
In this 48-hour acute toxicity test on Daphnia magna, the obtained results showed that the test item had significant toxic effects on the mobility of Daphnia. The 48-h EC50 value was determined to be 4.48 mg/L. The 48-h NOEC was determined to be 2.00 mg/L and the 48-h LOEC was determined to be 5.11 mg/L.
Reference
Analytical results
Concentrations of the test item were analytically determined at the start and at the end of each water renewal period.
The measured concentrations deviated more than 20 % from the nominal therefore the exposure concentrations were calculated as the geometric mean of the concentrations measured at the start and end of the water renewal periods
Table 1: Calculation of exposure concentrations
Nominal concentration |
Measured concentration[mg/L] |
|||||
1strenewal period |
2ndrenewal period |
Geometric mean |
||||
start |
end |
start |
end |
|||
Main Experiment |
Control |
not detected |
not measured |
not detected |
not measured |
Not Applicable |
0.0256* |
0.02 |
0.05 |
0.03 |
0.04 |
0.03 |
|
0.064* |
0.04 |
0.04 |
0.04 |
0.03 |
0.04 |
|
0.16 |
0.14 |
0.06 |
0.15 |
0.06 |
0.09 |
|
0.4 |
0.27 |
0.17 |
0.26 |
0.16 |
0.21 |
|
1.0 |
0.71 |
0.11 |
0.71 |
0.30 |
0.36 |
|
Complementary Experiment |
Control |
not detected |
not measured |
not detected |
not measured |
Not Applicable |
2.5 |
2.48 |
1.66 |
2.34 |
1.65 |
2.00 |
|
6.25 |
5.95 |
4.46 |
6.02 |
4.27 |
5.11 |
|
15.6 |
16.1 |
12.0 |
16.2 |
12.4 |
14.04 |
*this concentration level is not validated
In the Main Experiment:
The measured concentrations of the test item were in the range of 56
– 95 % of the nominal at the start and 11 – 68 % at the end of the
renewal periods.
In the Complementary Experiment:
The measured concentrations of the test item were in the range of 94
– 104 % of the nominal at the start and 66 – 79 % at the end of the
renewal periods.
Biological results:
Biological results are based on the measured test item concentrations.
Table 2: Immobilisation of the test animals (summary table)
Measured concentration |
Number of |
Number of immobilised |
% of immobilised |
||||
24 h |
48 h |
24 h |
48 h |
||||
Main Experiment |
Control |
20 |
0 |
0 |
0 |
0 |
|
0.03 |
20 |
0 |
0 |
0 |
0 |
||
0.04 |
20 |
1 |
1 |
5 |
5 |
||
0.09 |
20 |
0 |
0 |
0 |
0 |
||
0.21 |
20 |
0 |
0 |
0 |
0 |
||
0.36 |
20 |
1 |
1 |
5 |
5 |
||
Complementary Experiment |
Control |
20 |
0 |
0 |
0 |
0 |
|
2.00 |
20 |
0 |
1 |
0 |
5 |
||
5.11 |
20 |
0 |
13 |
0 |
65 |
||
14.04 |
20 |
0 |
20 |
0 |
100 |
Description of key information
In this 48-hour acute toxicity test on
Daphnia magna, the obtained results showed that the test item
Methyl-isobutyl-ketone-peroxide (MIKP) had significant toxic effects on
the mobility of Daphnia. The 48-h EC50 value was determined to be 4.48
mg/L. The 48-h NOEC was determined to be 2.00 mg/L and the 48-h LOEC was
determined to be 5.11 mg/L. The results are based on measured test item
concentrations.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 4.48 mg/L
Additional information
The influence of the test item
Methyl-isobutyl-ketone-peroxide (MIKP) on the mobility and survival of
Daphnia magna was determined in an acute toxicity study according to
OECD guideline 202 and EU method C.2.
Young Daphnia were exposed to aqueous test medium containing the test
item at concentrations of 0.0256, 0.064, 0.16, 0.4 and 1.0 mg/L. The
percentage of Daphnia being no longer capable of swimming at the end of
the test or being dead was recorded for each test concentration. As just
5% immobility was observed in the test concentrations of 0.064 and 1
mg/L in this test the toxicity of test item was further investigated at
higher concentrations of 2.5, 6.25 and 15.6 mg/L in a complementary
experiment to determine the EC50 value.
The measured concentrations deviated more than 20 % from the nominal
during the experiment therefore the geometric mean of the concentrations
measured at the start and end of the water renewal periods were
calculated to determine exposure concentrations. The corresponding
calculated geometric mean test item concentrations were: 0.03, 0.04,
0.09, 0.21, 0.36, 2.00, 5.11 and 14.04 mg/L.
In this 48-hour acute toxicity test on Daphnia magna, the obtained
results showed that the test item had significant toxic effects on the
mobility of Daphnia. The 48-h EC50 value was determined to be 4.48 mg/L.
The 48-h NOEC was determined to be 2.00 mg/L and the 48-h LOEC was
determined to be 5.11 mg/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.