Registration Dossier
Registration Dossier
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EC number: 203-532-3 | CAS number: 107-92-6
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: Meets generally accepted scientific standards; basic data given; comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Pre-guideline study, but method used is comparable to OECD test guideline 401
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Butyric acid
- EC Number:
- 203-532-3
- EC Name:
- Butyric acid
- Cas Number:
- 107-92-6
- Molecular formula:
- C4H8O2
- IUPAC Name:
- butyric acid
- Details on test material:
- - Name of test material (as cited in study report): n-Buttersäure (Butanoic acid)
- Analytical purity: 99 %
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: male: 250 g (mean); female 178 g (mean)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10, 14.7, 21.5, 31.6, 46.4, and 68.1 % (v/v) - Doses:
- 1000, 1470, 2150, 3160, 4640, 6810 µl/kg (960, 1400, 2060, 3030, 4450, and 6520 mg/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 632 mg/kg bw
- Remarks on result:
- other: reported LD50 = 1700 µL/kg bw
- Mortality:
- see tables
- Clinical signs:
- other: dyspnea, apathy, atonia, abdominal position , stagger, reduced general condition, spastic gait, exsiccosis
- Gross pathology:
- Animals that died:
Heart: acute dilatation, acute congestion hyperemia
stomachic:
intestinal:
sacrificed animals: NAD
Any other information on results incl. tables
Mortality
| Dose (µl/kg) | Conc. (%) | No. of animals | 1h | 24 h | 48 h | 7 days | 8 days |
| 6810 | 68.1 | 5 male | 5/5 | 5/5 | 5/5 | 5/5 | 5/5 |
| 5 female | 5/5 | 5/5 | 5/5 | 5/5 | 5/5 | ||
| 4640 | 46.4 | 5 male | 2/5 | 4/5 | 4/5 | 5/5 | 5/5 |
| 5 female | 1/5 | 5/5 | 5/5 | 5/5 | 5/5 | ||
| 3160 | 31.6 | 5 male | 0/5 | 2/5 | 3/5 | 5/5 | 5/5 |
| 5 female | 0/5 | 3/5 | 4/5 | 5/5 | 5/5 | ||
| 2150 | 21.5 | 5 male | 0/5 | 2/5 | 3/5 | 4/5 | 4/5 |
| 5 female | 0/5 | 3/5 | 3/5 | 3/5 | 3/5 | ||
| 1470 | 14.7 | 5 male | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 |
| 5 female | 0/5 | 1/5 | 2/5 | 2/5 | 2/5 | ||
| 1000 | 10.0 | 5 male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| 5 female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
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 determined to be ca. 1632 mg/kg bw in male and female rats in an study similar to OECD TG 401. According to EU regulation (Regulation (EC) No 1272/2008) classification to acute toxicity category 4 is required.
- Executive summary:
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.
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 oral LD50 was determined to be 1630 mg/kg bw in male and female rats (BASF, 1978)
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