Butane-1,3-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1951

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study with sufficient details reported in former publications, but purity of the substance not stated and some study details are lacking.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1951

Report date:

1951

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1949

Report date:

1949

Reference 3

Reference Type:

publication

Title:

Unnamed

Year:

1948

Report date:

1948

Reference 4

Reference Type:

publication

Title:

Unnamed

Year:

1944

Report date:

1944

Materials and methods

Principles of method if other than guideline:

acute oral toxicity test

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,3-diol

EC Number:

203-529-7

EC Name:

Butane-1,3-diol

Cas Number:

107-88-0

Molecular formula:

C4H10O2

IUPAC Name:

butane-1,3-diol

Test material form:

liquid

Details on test material:

Name of test material (as cited in study report): 1,3-butanediol

Test animals

Species:

rat

Strain:

other: Wistar or Sherman

Sex:

male

Details on test animals or test system and environmental conditions:

- Age at study initiation: 90-120 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

geometrical series of dosis, e.g. 1, 2, 4 and 8 g/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Single oral administration was performed in non-fasted animals with an initial start dose, derived from "experience with other substances". One week later other doses were tested with new groups of animals until two doses (differing by a factor of 10) were determined which kill some or all animals and some or no animal, respectively. The duration of observation period following administration was 14 days.

Statistics:

LD50 values (designated as "range finding LD50") were calculated bya method of Thompson (reference stated) and reported +/- 1.96 standard deviations (SD)

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

22 800 mg/kg bw

Remarks on result:

other: LD50 +/- 1.96 SD: 21800-23900

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity in male rats was low (LD50: 22800 mg/kg bw).

Executive summary:

Non-fasted male rats were given single oral doses of the test item. The LD50 (observation period: 14 days) was 22800 mg/kg bw (Smyth et al., 1951).