α-acetyl-γ-butyrolactone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: usual manner

Principles of method if other than guideline:

The test substance is administered orally by gavage in graduated doses to several groups of experimental animals for 5 days, one dose being used per group. Subsequently observations of effects and deaths are made after 24 hours, 2 days, 3 days, 4 days, 5 days followed by an post observation period of 10 days (= 15 days after the first dosage).

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

α-acetyl-γ-butyrolactone

EC Number:

208-235-2

EC Name:

α-acetyl-γ-butyrolactone

Cas Number:

517-23-7

Molecular formula:

C6H8O3

IUPAC Name:

3-acetyloxolan-2-one

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

no further information available

Doses:

1000, 2000, 4000 and 8000 mg/kg bw

No. of animals per sex per dose:

10 animals per dosage group

Control animals:

no

Details on study design:

no further information available

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Remarks:

observation period: 24 hours

Effect level:

5 640 mg/kg bw

Effect levels 2

Sex:

not specified

Dose descriptor:

other: LD90

Remarks:

observation period: 24 hours

Effect level:

7 080 mg/kg bw

Effect levels 3

Sex:

not specified

Dose descriptor:

other: LD10

Remarks:

observation period: 24 hours

Effect level:

4 500 mg/kg bw

Effect levels 4

Sex:

not specified

Dose descriptor:

discriminating dose

Remarks:

treatment over 5 days and 10 days post observation period

Effect level:

3 000 mg/kg bw

Mortality:

24 hours after the first administration:
8000 mg/kg bw: 10/10 dead
4000 mg/kg bw: 0/10
2000 mg/kg bw: 0/10
1000 mg/kg bw: 0/10

Clinical signs:

other: sedation, hypoventilation

Gross pathology:

not examined

Any other information on results incl. tables

Although the LD50 value was calculated from a study with repeated administration (5 days), taken the mortality data 24 hours after the first administration, this value allows for a reliable assessment of the acute oral toxicity. The LD50 value is still above 2000 mg/kg bw even if the dosage was extented over five days (post observation period: 10 days).

Applicant's summary and conclusion

Executive summary:

The tests were carried out in the usual manner (oral, gavage), 10 animals per dosage group. The lethal doses were determined by the computer method developed by Dr S. Wolf. The LD 10, LD 50, and LD 90 are calculated on the basis of the mortality data reported 24 hours after administration of a single dose. the LD 50 value for the test substance was reported to be > 2000 mg/kg bw.