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EC number: 201-195-7 | CAS number: 79-31-2
- 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:
- 20.08.1985 - 10.09.1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isobutyric acid
- EC Number:
- 201-195-7
- EC Name:
- Isobutyric acid
- Cas Number:
- 79-31-2
- Molecular formula:
- C4H8O2
- IUPAC Name:
- 2-methylpropanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Meprosan
- Physical state: liquid
- Analytical purity: >99 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: WISW (SPF THO)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen, Germany
- Weight at study initiation: male: 124 g; female: 107 g
- Fasting period before study: 16 hrs
- Housing: 1 -5 animals each cage (Makrolon Typ III)
- Diet (e.g. ad libitum): R10 Alleindiät für Ratten, Ssniff Spezialfutter GmbH, 4770 Soest, ad libidum
- Water (e.g. ad libitum): tap water, ad libidum
- Acclimation period: 4-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15x
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.09 - 3.33 cm3/kg
- Doses:
- 1990, 2510, 2835, 3160 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Animals were weighed before treatment and on day 1, 7 and 14; observations were recorded up to 6 hrs following treatment and daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Determination of LD50 according to Litchfield and Wilcoxon (J. Pharmacol. Exp. Ther. 96, 1949, p. 99)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 230 mg/kg bw
- 95% CL:
- 2 009 - 2 475
- Mortality:
- 1990 mg/kg bw: 2/5 (male), 1/5 (female) within 4 days; 2510 mg/kg bw: 3/5 (male), 5/5 (female) within 11 days
2835 mg/kg bw: 5/5 (male), 4/5 (female) within 11 days; 3160 mg/kg bw: 3/5 (male), 5/5 (female) within 4 hours - Clinical signs:
- other: 5 - 30 min after treatment, the animals showed slight to severe sedation and ataxia, lateral and prone position, labored breathing, staggering. Later on hypothermia, ruffled fur, trembling, bloody noses and snouts, and blood in the urine. Signs persist
- Gross pathology:
- Animals that died: hyperemia and distension was noted in the stomach, small intestine, and the bladder, and bloody contents were noted in these organs. Corrosion of the stomach wall was noted in some of the animals.
Animals sacrificed at termination: hyperemia, discoloring of the instestinal mucosa, swelling of the stomach mucosa was noted in some instances. Adhesions of the stomach, liver and spleen were noted in 3 survivors.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 was 2230 mg/kg bw in male and female rats in an OECD 401 study.
- Executive summary:
The acute oral toxicity was determined in a valid OECD 401 study in groups of 5 male and female rats, receiving a dose of 1990, 2510, 2835, 3160 mg/kg bw by oral gavage.
The clinical signs. i.e. sedation, ataxia, ruffled fur, hypothermia and staggering, persisted in some animals until the end of the 14-day observation period. Dead animals suffered from gastro-intestinal hemorrhage as result of the corrosive activity of the isobutyric acid.
The oral LD50 was 2230 (2009 - 2475) mg/kg bw (Hüls AG, 1985).
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