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Toxicological information

Acute Toxicity: oral

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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:
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:
1949
Report Date:
1949
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 oral toxicity test
GLP compliance:
no
Test type:
standard acute method
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:
other: Wistar or Sherman
Sex:
male
Details on test animals 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).