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EC number: 207-975-3 | CAS number: 503-74-2
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guideline studies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isovaleric acid
- EC Number:
- 207-975-3
- EC Name:
- Isovaleric acid
- Cas Number:
- 503-74-2
- Molecular formula:
- C5H10O2
- IUPAC Name:
- 3-methylbutanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Isovaleriansäure; substance No. 77/520
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: males 184 g ; females 162 g (means)
- Fasting period before study: 15-20 hr
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% and 1-2 drops of Chremophore El.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:6.8 - 50%
- Amount of vehicle (if gavage): dose volume: 10 mL/kg bw
- Justification for choice of vehicle: aqueous solution of 0.5% CMC
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 681, 1000, 1470, 2150, 2610, 3160, 3830, and 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not needed
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: on days 0, 2-4, 7, and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- see table below
- Clinical signs:
- other: Dyspnea, apathy, unkempt fur, and poor condition was seen at 1000 mg/kg bw and above. Cyanosis, atony, unsteady gait was seen at 1470 mg/kg bw and above; narcosis, impaired pain reflexes, trembling, exsiccation and exophthalmia was seen at 2610 mg/kg bw a
- Gross pathology:
- Dead animals: heart: hyperaemic congesting; glandular stomach: haemorrhage, gastritis; intestine: reddened mucosa, injected vessels.
Surviving animals: forestomach: button formation (in groups 1470-3160 mg/kg bw; wall thickened in animals at 215ß-3160 mg/kg bw. No changes in animals at 681-1000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of isovaleric acid was approx. 2500 mg/kg bw in male and female rats
- Executive summary:
The acute oral toxicity of isovaleric acid was determined in male and female Sprague-Dawley similar to OECD 401 (5 rats/sex; oral gavage; test substance at 681, 1000, 1470, 2150, 2610, 3160, 3830, and 5000 mg/kg bw in 0.5% CMC; observation period 14 days). Signs of toxicity were seen at 1000 mg/kg bw and above in a dose-dependent manner. No deaths occurred at doses up to and including 2150 mg/kg bw, with a steep increase of mortality at higher doses. The LD50was ca. 2500 mg/kg bw for male and female rats. Necropsy revealed lesions in the stomach and intestine that are attributable to the irritating property of the isovaleric acid (BASF, 1980).
The study is considered to be valid and suitable for assessment.
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