Heptanoic acid

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: 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