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Toxicological information

Acute Toxicity: oral

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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:
1978
Report date:
1978
Reference Type:
other company data
Title:
Unnamed
Year:
1990
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

Constituent 1
Chemical structure
Reference substance name:
Butyric acid
EC Number:
203-532-3
EC Name:
Butyric acid
Cas Number:
107-92-6
Molecular formula:
C4H8O2
IUPAC Name:
butanoic acid
Details on test material:
- Name of test material (as cited in study report): n-Buttersäure (Butanoic acid)
- Analytical purity: 99 %

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:
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)