Butane-1,3-diol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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:

1948

Report date:

1948

Reference 3

Reference Type:

publication

Title:

Unnamed

Year:

1944

Report date:

1944

Materials and methods

Principles of method if other than guideline:

acute inhalation toxicity test, similar to the inhalation hazard test described in OECD guideline 403.

GLP compliance:

no

Test type:

other: inhalation hazard test

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:

Wistar

Sex:

male

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

exposure to saturated vapour

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 8 h

Concentrations:

saturated vapour, concentration not stated in the publication; a concentration of about 78 ppm (292 mg/m3) can be estimated based on a vapour pressure of 0.08 hPa at 20 °C.

No. of animals per sex per dose:

6 males

Control animals:

not specified

Details on study design:

The animals were exposed for up to 8 h (geometric time series with a factor of 2) to a stream of air, saturated with vapours of the test substance. The saturation was performed by passing the air through a fritted disc bubbler at room temperature. The duration of observation period following administration was 14 days.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

not specified

Dose descriptor:

LC0

Effect level:

78 ppm

Based on:

other: saturated vapour

Exp. duration:

8 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Effect levels 2

Key result

Sex:

not specified

Dose descriptor:

LC0

Effect level:

292 mg/m³ air

Based on:

other: saturated vapour

Remarks:

calculated based on a vapour pressure of 0.08 hPa at 20 °C

Exp. duration:

8 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Any other information on results incl. tables

No deaths occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A single 8 h exposure to saturated vapour (concentration not stated, about 78 ppm or 292 mg/m3) produced no mortality in male rats.

Executive summary:

No lethal effects were observed in male rats after a single 8 h of exposure to saturated vapour (concentration not stated, about 78 ppm or 292 mg/m3) (Smyth et al., 1951).