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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 January 2019 - 15 February 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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: 31/10/2020
- Purity test date:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (20 ± 5°C); Keep away from humidity
- Stability under test conditions: Stable
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Slovak Academy of Sciences Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation:
- Fasting period before study: 10-12 hours
- Housing: plastic cages suspended on stainless steel racks, 3 animals per cage in a room equipped with central air-conditioning.
- Diet (e.g. ad libitum): The laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was available at libitum.
- Water: ad libitum - The animals received tap water for human consumption.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.12 ± 0.24 °C
- Humidity (%): 54.92 ± 2.46 %
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark cycle
IN LIFE DATES: 24/01/2019 - 15/02/2019
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Aqua pro injectione
- Remarks:
- Aqua pro injectione is a common vehicle in toxicity studies like OECD TG 423
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/kg
- Amount of vehicle (if gavage): 5mL/kg bw
- Justification for choice of vehicle: Aqua pro injectione is a common vehicle in toxicity studies like OECD TG 423
- Lot/batch no. (if required): 18E2302
- Purity: certificate of analysis provided in study report.
CLASS METHOD
- Rationale for the selection of the starting dose:
The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Individual weights of animals were measured immediately prior to administration of the test item and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ appearance
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.
- Clinical signs:
- other: During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.
- Gross pathology:
- All animals were necropsied. During necropsy, no macroscopic findings were observed.
Any other information on results incl. tables
Clinical Observation
Observation |
Time After Administration |
||||||||||||||||||
Hour |
Day |
||||||||||||||||||
Immediately |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
Skin and Hair |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Tremor |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
-No observed signs
Body Weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
210 |
243 |
257 |
33 |
47 |
14 |
2 |
214 |
223 |
219 |
9 |
5 |
-4 |
||
3 |
219 |
234 |
243 |
15 |
24 |
9 |
||
4 |
244 |
261 |
324 |
17 |
80 |
63 |
||
5 |
238 |
252 |
268 |
14 |
30 |
16 |
||
6 |
238 |
252 |
267 |
14 |
29 |
15 |
Necropsy Results
Sex |
Dose |
ID |
Result |
Sex |
Dose |
ID |
Result |
♀ |
2000 mg/kg |
1 |
no finding |
♀ |
2000 mg/kg |
4 |
no finding |
2 |
no finding |
5 |
no finding |
||||
3 |
no finding |
6 |
no finding |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item “Potassium isobutyrate” is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item “Potassium isobutyrate” is according to to Regulation (EC) No 1272/2008 (EU CLP) unclassified with a LD50 cut off value of equal to or greater than 2000 mg/kg body weight, after single oral administration to Wistar rats. - Executive summary:
SUMMARY
The purpose of the study was to evaluate the potential toxic effect of the test item “Potassium isobutyrate”when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class(ATC)method was used.
A limit dose of 2000 mg/kg body weight was used as a starting dose.The test itemadministeredto 6 females at a limit dose did not cause death.The body weights of all animals increased during the study. A slight decrease of body weight in one animal was observed between the first and second week after administration of the test item.During necropsy, no macroscopic findings were observed.
The LD50 of the test item “Potassium isobutyrate”is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item “Potassium isobutyrate”is according to Regulation (EC) No 1272/2008 (EU CLP) unclassified with a LD50cut off value of equal to or greater than 2000 mg/kg body weight,after single oral administration to Wistar rats.
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.
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