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EC number: 243-077-8 | CAS number: 19455-20-0
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 December - 05 December 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 13 April 2004
- Deviations:
- yes
- Remarks:
- M4-medium (husbandry) was switched to Dilution water (test). See justification below.
- Principles of method if other than guideline:
- Deviations from the Guideline
Switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test daphnia, therefore no acclimation period of 48 h was performed. This is a deviation from OECD Guideline No. 202 and EU-Method C.2, which can be considered uncritical. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium isobutyrate
- EC Number:
- 243-077-8
- EC Name:
- Potassium isobutyrate
- Cas Number:
- 19455-20-0
- Molecular formula:
- C4H8O2.K
- IUPAC Name:
- potassium 2-methylpropanoate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / 181101001
- Expiration date of the lot/batch: 31 Oct 2020
- Purity test date: 01 Nov 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in the test facility in a closed vessel at room temperature (16.2 – 23.7 °C) away from humidity and under inert gas.
- Solubility and stability of the test substance in the solvent/vehicle:
Stability: H2O: 96h; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility: H2O: > 1 g/L; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The test item was solid, because of its hygroscopic properties, and therefore, it was dried overnight at 145 °C.
A test solution containing 101.6 mg/L test item in dilution water was prepared for the test.
- Final preparation of a solid: as above.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : In solution
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: Sample preparation: Before measurement the taken samples were diluted (10 fold) with dilution water, to stay in the calibrated range.
On each sampling day, validity of calibration was controlled by measuring QC samples (10 mg/L).
At the beginning of the study a new calibration was performed. The measured QC sam-ples were not taken into account. The mean QC value at the end of the experiment (107.7 %, mean of 108.7 %, 105.9 %, 108.0 %, 107.7 %, 107.4 % and 108.3 %) was higher than ± 3 % and therefore, taken into account.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- A test solution containing 101.6 mg/L test item in dilution water was prepared for the test.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: STRAUS
- Age at study initiation (mean and range, SD): 0-24 hours
- Method of breeding: Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical
- Source: Umweltbundesamt Berlin
- Feeding during test : No
- Food type: green algae (Desmodesmus subspicatus)
- Frequency: twice a week
ACCLIMATION
- Acclimation period: None
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 24 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- Not reported
- Test temperature:
- 18.1-20.5
- Nominal and measured concentrations:
- 100 mg/L (nominal concentration)
The concentrations to be tested are based on the result of a non-GLP pre-test. - Details on test conditions:
- TEST SYSTEM
- Test vessel: flask
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass beakers, nominal volume 50 mL, tall shape
- Volume of solution: 50 mL
- Aeration: test system was not aerated. Dilution water was aerated after preparation.
- Renewal rate of test solution (frequency/flow rate): N/A
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 vessels, each containing 20 ± 5 mL test solution and 5 daphnia
- No. of vessels per vehicle control (replicates): 4 vessels, each containing 20 ± 5 mL test solution and 5 daphnia
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water (Daphnia medium) with the following specification was used (stated in SOP 11800201)
Parameter Concentration in mg/L
CaCl2*2H2O 293.80
MgSO4*7H2O 123.30
NaHCO3 64.80
KCl 5.80
Deviations from the nominal weighted loads were less than 5 %. Exact values are record-ed in the raw data. After preparation, the dilution water was aerated and the pH was measured. The pH was 7.7.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16/8 hours using neon tubes
- Light intensity: not recorded
VEHICLE CONTROL PERFORMED: yes
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study (201910R201).
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Results with reference substance (positive control):
- The 24h-EC50 value was determined as 2.07 mg/L. The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium dichromate K2Cr2O7 as speci-fied in the OECD guideline.
- Reported statistics and error estimates:
- Calculation of results was performed with the help of validated software (Microsoft Excel®).
Any other information on results incl. tables
Findings
Immobility
In the blank control, none of the daphnia was immobilised (see table below).
Table 4. Immobility
Nominal Concentration in mg/L |
Immobility 24 hours |
Immobility 48 hours |
||||||||
absolute |
in % |
absolute |
in % |
|||||||
Blank control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
pH and O2
The pH values and the concentration of dissolved oxygen in the test media and the blank control are given in the following table:
Table 5.pH and O2-values
Nominal Concentration in mg/L |
pH |
O2-Concentration in mg/L |
||
0 h |
48 h |
0 h |
48 h |
|
Blank control |
7.6 |
7.6 |
8.2 |
9.1 |
100 |
7.7 |
7.6 |
8.1 |
9.1 |
Analytical Determinations
At the beginning and at the end of the test, the content of the test item in the test solutions was determined usingHPLC-UV-determination. The concentration determined at the start of the test was 102 % of the nominal concentration. At the end of the test the determined concentration was 113 % of the nominal concentration. Therefore, the determination of the biological results was based on the nominal concentration (see Guidance Doc. No.23 (§176)).
At the beginning of the test, a new calibration was performed.
Detailed data are given in the following tables:
Table 6.Measured Concentrations at 0 h
Nominal |
Area |
Measured Concentration |
QC recovery |
Dilution factor |
Calculated Concentration |
Mean (including accuracy of 102.2 %) |
mg/L |
mAU*min |
mg/L |
% |
-- |
mg/L |
mg/L |
Blank control |
n. a. |
-- |
-- |
-- |
-- |
-- |
100 |
0.2910 |
10.11 |
-- |
10 |
101.10 |
101.72 |
0.3082 |
10.68 |
-- |
10 |
106.82 |
Table 7.Measured Concentrations after 48 h
Nominal |
Area |
Measured Concentration |
QC recovery |
Dilution factor |
Calculated Concentration |
Mean (including accuracy of 102.2 %) |
mg/L |
mAU*min |
mg/L |
% |
-- |
mg/L |
mg/L |
10 (QC sample) |
0.1528 |
5.43 * |
108.7 |
-- |
5.00 |
-- |
0.1488 |
5.30 * |
105.9 |
-- |
5.00 |
||
0.1518 |
5.40 * |
108.0 |
-- |
5.00 |
||
0.1514 |
5.39 * |
107.7 |
-- |
5.00 |
||
Blank control |
n. a. |
-- |
107.7 |
-- |
-- |
-- |
100 |
0.3637 |
12.52 |
107.7 |
10 |
116.26 |
112.95 |
0.3583 |
12.34 |
107.7 |
10 |
114.61 |
||
10 (QC sample) |
0.1510 |
5.37 * |
107.4 |
-- |
5.00 |
-- |
0.1523 |
5.42 * |
108.3 |
-- |
5.00 |
* Because of a sample preparation error, the real concentration of the QC sample was 5 mg/L.
Table 8.% of Nominal Concentration
Nominal |
% of Nominal Concentration |
|
mg/L |
t = 0 h |
t = 48 h |
Blank control |
-- |
-- |
100 |
102 |
113 |
Biological Results
The biological results are presented in the following table:
Table 9. Biological Results Test Item
Parameter |
Value |
24h EC50 |
> 100 mg/L |
48h EC50 |
> 100 mg/L |
48h NOEC |
≥100 mg/L |
48h LOEC |
> 100 mg/L |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- One valid experiment was performed.
The study was performed as a limit test with the nominal concentration of 100 mg/L. For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 23.5 and 48 hours, the immobilised daphnia were counted.
None of the animals was immobilised in the blank control and the test concentration.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.
At the beginning and at the end of the test, the content of the test item in the test solutions was determined using HPLC-UV-determination. The concentration determined at the start of the test was 102 % of the nominal concentration. At the end of the test the determined concentration was 113 % of the nominal concentration. Therefore, the determination of the biological results was based on the nominal concentration (see Guidance Doc. No.23 (§176)).
No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.
The result of the test is considered valid. - Executive summary:
Findings and Results:
One valid experiment was performed.
The study was performed as a limit test with the nominal concentration of 100 mg/L. For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.
None of the animals was immobilised in the blank control and the test concentration.
Potassium dichromate K2Cr2O7(CAS No. 7778-50-9) was used as positive controlin a current reference study to assure that the test conditions are reliable.
At the beginning and at the end of the test, the content of the test item in the test solutions was determined usingHPLC-UV-determination. The concentration determined at the start of the test was 102 % of the nominal concentration. At the end of the test the determined concentration was 113 % of the nominal concentration. Therefore, the determination of the biological results was based on the nominal concentration (see Guidance Doc. No.23 (§176)).
The following results were determined for the test itemPotassium isobutyrate (species:Daphnia magna).
48h-NOEC≥100 mg/L
48h-LOEC> 100mg/L
24h-EC50> 100 mg/L
48h-EC50> 100 mg/L
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