Registration Dossier

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:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1951
Report Date:
1951
Reference Type:
publication
Title:
Unnamed
Year:
1948
Report Date:
1948
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

Reference
Name:
Unnamed
Type:
Constituent
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 levelsopen allclose all
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
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).