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EC number: 203-383-4 | CAS number: 106-31-0
- 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
Endpoint summary
Administrative data
Description of key information
The oral LD50 of butyric acid was determined to be 1632 mg/kg bw in rats (BASF, 1978).
Hydrolysis study data, provided in section 5.1.2 will be used to demonstrate that butyric anhydride in an aqueous environment will undergo almost immediate hydrolysis to butyric acid. Thus, study data from butyric acid will be used to satisfy all data points in section 7, as water will be present in all of the studies.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 632 mg/kg bw
Additional information
Acute toxicity: oral
For assessment of the acute oral toxicity of butyric acid three valid studies are available. Two of them (Smyth, 1951 and 1954) originate from the same laboratory and were performed basically using the same method but with male and female rats at different times respectively. The LC50 for male rats is much lower than for females. The third study used rat of both sexes. No differences were notice. In this study the lowest LD50 was determined. This study is taken as key study.
BASF 1978 (key study)
In an acute oral toxicity study, groups of 5 male and 5 female Sprague-Dawley rats were given a single oral dose of butyric acid (purity ≥ 99%) in water at doses of 960, 1400, 2060, 3030, 4450, and 6520 mg/kg bw. Test animals were then observed for 14 days.
There were no obvious differences between sexes. Clinical signs were dyspnea, apathy, atonia, abdominal position, stagger, reduced general condition, spastic gait, exsiccosis. Dead animals showed acute dilatation and acute congestion hyperemia of the heart. In the stomach, fibrinous hemorrhagic caustic gastritis was noticed. Intestine content was hemorrhagic and loose. In the organs of sacrificed animals, no abnormalities were detected.
The acute oral LD50 was determined to be 1630 mg/kg bw in male and female rats (BASF, 1978)
Smyth 1951
The acute oral toxicity of butyric acid was determined in groups of 5 male Sherman rats receiving each a single oral dose of the test substance by gavage. The doses were spaced by a factor of 2 (geometrical series, at least four graduate doses, individual doses not specified). The observation period was 14 days. The LD50 and a range of ± 1.96 SD was calculated according to the method of Thomson (1947). Overall, the study was conducted similar to the recently retracted OECD test guideline 401.
The acute oral LD50 was 2940 mg/kg bw in male rats (Smyth, 1951).
Smyth 1954
The acute oral toxicity of butyric acid was determined in groups of 5 female Carworth-Wistar rats receiving each a single oral dose of the test substance by gavage. The doses were spaced by a factor of 2 (geometrical series, at least four graduate doses, individual doses not specified). The observation period was 14 days. The LD50 and a range of ± 1.96 SD was calculated according to the method of Thomson (1947). Overall, the study was conducted similar to the recently retracted OECD test guideline 401.
The acute oral LD50 was 8790 mg/kg bw in female rats (Smyth, 1954).
Justification for classification or non-classification
Acute oral toxicity
The LD50 of the key study (lowest reported LD50) was 1632 mg/kg bw in rats. According to Regulation (EC) No 1272/2008 classification as acute toxic Category 4 is required.
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