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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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Industrial Biotest Laboratory was found to use fraudulent practices in some of their studies and reports. Since these studies were performed before the implementation of Good Laboratory Practices, it is not possible to verify the scientific credibility of most of these studies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptanoic acid
EC Number:
203-838-7
EC Name:
Heptanoic acid
Cas Number:
111-14-8
Molecular formula:
C7H14O2
IUPAC Name:
heptanoic acid
Details on test material:
substance: heptanoic acid (SN-1767)
physical state : a clear, colorless liquid.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:no data
- Age at study initiation:no data
- Weight at study initiation: no data
- Fasting period before study: yes, during the 16-hour period immediately prior to oral intubation
- Housing: in stock cages
- Diet (e.g. ad libitum): standard laboratory died, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS : no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1350, 4556, 6834, 10250 and 15380 mg/kg bw
No. of animals per sex per dose:
2 animals/sexe/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at the biginning and at 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 370 mg/kg bw
Remarks on result:
other: SD +/- 1203 mg/kg
Mortality:
1350 mg/kg bw : no mortality
4556 mg/kg bw: no mortality
6834 mg/kg bw: 1 died animal (1F)
10250 mg/kg bw: 3 died (1M, 2F)
15380 mg/kg bw: 4/4 died
Clinical signs:
Hypoactivity and salvation were observed at all doses.
At 4556 mg/kg and above : labored breathing, muscular weakness, prostation.
At 6834 mg/kg and above : vasoconstriction, diuresis
At 10250 mg/kg and above : diarrhea
Gross pathology:
none
Other findings:
Necropsy examination of the animals that died revealed red and/or hemorrhaged lungs.
In addition, the rats at the 10250 and 15380 mg/kg dose levels exhibited chemical byrns in the gastrointestinal tracts and blood in the urinary bladders.

Applicant's summary and conclusion

Conclusions:
Heptanoic acid is pratically non toxic with a LD50 of 8370 mg/kg