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Registration Dossier
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EC number: 203-529-7 | CAS number: 107-88-0
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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 951
- Report date:
- 1951
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 949
- Report date:
- 1949
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 948
- Report date:
- 1948
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 944
- 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 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
Constituent 1
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).
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