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EC number: 204-145-2 | CAS number: 116-53-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other: TSCAT submission
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-methylbutyric acid
- EC Number:
- 204-145-2
- EC Name:
- 2-methylbutyric acid
- Cas Number:
- 116-53-0
- Molecular formula:
- C5H10O2
- IUPAC Name:
- 2-methylbutanoic acid
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-methylbutyric acid
- Analytical purity: 97.9%
- Impurities (identity and concentrations): valeric acid 1.8%; unidentified 0.3%
- Stability under test conditions: shell life > 6 months
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: overnight
- Diet: standard lab diet ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 4 mL/kg bw
- Doses:
- males: 1.0, 2.0, 4.0 mL/kg bw
females: 0.25, 0.5, 1.0, 2.0, 4.0 mL/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
- Frequency of observations and weighing: on days 0 (prior to treatment), 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 value was calculated using the moving average method (Thompson, 1947; Weil, 1983)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 750 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Using a density of 0.936 kg/L, the calculated LD50 of 1.87 mL/kg bw is equivalent to 1750 mg/kg bw
- Mortality:
- Most deaths occurred at 1.5 to 2 days. However, three females died at 10 to 14 days. Survivors recovered at one to three days.
Males: 0/5, 3/5 and 5/5 of the low, middle and high dose group died
Females: 0/5, 0/5, 1/5, 2/5, 5/5 of the 0.25, 0.5, 1, 2, 4 mL/kg bw dose group died, respectively - Clinical signs:
- Signs of toxicity included sluggishness, lacrimation, unkempt fur, kyphosis (in 2), prostration, a moribund appearance, diarrhea, red to brown discharge on perioral, perinasal and periurogenital fur.
- Body weight:
- Males: body weight gain at 1.0 mL/kg bw; bodyw eight reduced at 2.0 mL/kg bw
Females: no body weight gain at all dose levels - Gross pathology:
- Dead animals: stomach abnormalities (discoloration, brown liquid or gas, gastric collapse); discoloure dlungs; brown to dark red livers, intstines, and kidneys.
Survivors: small stomachs and spleens; rough stomach surfaces, adhesion of the stomach to liver or spleen, enlarged and mottled red kidneys.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 was 1750 mg/kg bw in male and female rats. Necropsy findings in survivors revealed irritation/corrosion of the stomach and intestines.
- Executive summary:
Oral toxicity was investigated in a study similar to OECD TG 401. Male and female rats (n=5 per sex per dose) were exposed against different doses of test substance up to 4 mL/kg bw (3744 mg/kg bw by calculation on basis of substance density of 0.936 kg/L). Exposed animals showed signs of toxicity including sluggishness, lacrimation, unkempt fur, kyphosis, prostration, a moribund appearance, diarrhea, red to brown discharge on perioral, perinasal and periurogenital fur. Female rats of all dose groups and male rats at doses >= 2 mL/kg bw did not gain body weight. The following findings were observed at necropsy of dead animals: stomach abnormalities (discoloration, brown liquid or gas, gastric collapse), discoloured lungs, brown to dark red livers, intstines, and kidneys. Necropsy of the surving animals revealed the following effects: small stomachs and spleens; rough stomach surfaces, adhesion of the stomach to liver or spleen, enlarged and mottled red kidneys.Using the moving average method an LD50 value of 1.87 mL/kg bw (corresponding to 1750 mg/kg bw) was calculated for male and female rats.
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