Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
This endpoint study record is the experimental source record for the registered target substance.

Data source

Reference
Reference Type:
publication
Title:
RANGE-FINDING TOXICITY DATA: LIST IV
Author:
Smyth HF, Carpenter CP & Weil CS
Year:
1951
Bibliographic source:
AMA Arch Ind Hyg Occup Med (1951) 4:199-122

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Lacking details in methodology and results
GLP compliance:
no
Remarks:
Study pre-dates GLP requirements
Limit test:
no

Test material

Constituent 1
Chemical structure
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:
no impurities described

Test animals

Species:
rat
Strain:
other: albino
Sex:
male

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
clean air
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
saturated vapour concentration
No. of animals per sex per dose:
6 males/dose
Control animals:
not specified
Details on study design:
The animals were exposed for up to 8 hours 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
Sex:
male
Dose descriptor:
LC0
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
No deaths were reported following exposure to a saturated vapour
Mortality:
No deaths occurred.
Clinical signs:
other: Not reported
Body weight:
Not reported
Gross pathology:
Not reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single 8-hour exposure to a saturated vapour produced no mortality.
Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.

No lethal effects were observed in rats after a single 8-hour exposure to a saturated vapour.