Valeric acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1987

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:

BASF-Test to determine acute oral toxicity in rats

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Valeric acid

EC Number:

203-677-2

EC Name:

Valeric acid

Cas Number:

109-52-4

Molecular formula:

C5H10O2

IUPAC Name:

pentanoic acid

Constituent 2

Reference substance name:

n-valeric acid

IUPAC Name:

n-valeric acid

Details on test material:

- Name of test material (as cited in study report): Valeric acid, substance ID: 77/505
- Physical state: clear liquid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht Extertal, Germany
- Mean weight at study initiation: males: 195 g, females 193 g
- Fasting period before study: no data
- Diet: Herilan MRH ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

VEHICLE
- Concentration in vehicle: 10, 21.5, 31.6, 46.4 and 50 %

Doses:

2150, 3160, 4640, 6810 mg/kg bw

No. of animals per sex per dose:

10 animals (5 males, 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis (Finney)

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 600 mg/kg bw

Mortality:

Males /females:
6810 mg/kg bw: 4/5 out of 5
4640 mg/kg bw: 2/4 out of 5
at lower dose levels no death occurred

Clinical signs:

other: irregular respiration, apathy, abdominal position, staggering, atony, narcosis-like state, absent pain reflex, piloerection, diarrhea, exsiccosis, bloody excrements; local signs of irritation, salivation, bad general condition

Gross pathology:

4640 and 6810 mg/kg dosing groups: acute dilatation of the right ventricle, gastritis, local adhesions of stomach and liver;
2150 and 3160 mg/kg dosing groups: organs without findings

Other findings:

Not applicable

Any other information on results incl. tables

Results of the preliminary study involving 3 males and 3 females per dosing group:

1000 mg/kg bw. 0/2 females died

2000 mg/kg bw: 3/3 males and 2/3 females died

4000 mg/kg bw: no death occurred within the study period of 14 days.

The preliminary study was conducted under the same conditions as the main study. Clinical signs of toxicity are comparable to the clinical signs observed in the main study. No other signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for male and female rats was 4600 mg/kg.