γ-valerolactone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not available, publication received 1945-05-31

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Observations on the effects of gamma-valerolactone upon experimental animals

Author:

Deichmann WM. B., Hirose R., Witherup S.

Year:

1945

Bibliographic source:

Journal of industrial hygiene and toxicology, 27: No. 9

Report date:

1945

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: The purpose of this investigation was to determine the immediate toxicity of the test item by oral administration to rats and its effects upon respiration and blood pressure.

- Short description of test conditions: Rats were treated with different volumes of the test item by gavage. No details about sex, environmental conditions or time schedule of the experiment are given.

- Parameters analysed / observed: Clinical signs, blood pressure and mortality

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

γ-valerolactone

EC Number:

203-569-5

EC Name:

γ-valerolactone

Cas Number:

108-29-2

Molecular formula:

C5H8O2

IUPAC Name:

5-methyloxolan-2-one

Specific details on test material used for the study:

No details given.

Test animals

Species:

rat

Strain:

Wistar

Sex:

not specified

Details on test animals or test system and environmental conditions:

IN-LIFE DATES: At least 36 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
16 mL/kg bw

Doses:

4.7, 7.0, 10.0, 16.0 mL/kg bw

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 36 hours
- Necropsy of survivors performed: No
- Clinical signs: Locomotor system, state of consciousness, respiration
- Other examinations: Blood pressure was recorded by means of a kymograph

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

9 249 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Effect level was converted from 8.8 mL/kg bw to 9249 mg/kg bw

Mortality:

10% mortality at 4.7 mL/kg bw (survival time 36 hours), 20% mortality at 7.0 mL/kg bw (survival time 10-14 hours), 70% mortality at 10 mL/kg bw (survival time 1-6 hours), 90% mortality at 16 mL/kg bw (survival time 35 min to 12 hours)

Clinical signs:

other: Clinical signs were marked muscular weakness, mild anesthesia, increase in the rate of respiration, followed by dyspnea and occasionally by mild asphyxial convulsions. Death resulted from combined effects of circulatory and respiratory failure.

Gross pathology:

No information given

Other findings:

No information given

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met