Registration Dossier
Registration Dossier
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EC number: 443-800-9 | CAS number: 40031-31-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Method B.1 of Commission Directive 92/69/ EEC (which constitutes Annex V of Council Directive 67/548/EEC)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 443-800-9
- EC Name:
- -
- Cas Number:
- 40031-31-0
- Molecular formula:
- C4H8O4
- IUPAC Name:
- (3S)-1,3,4-trihydroxybutan-2-one
- Test material form:
- liquid: viscous
- Details on test material:
- NA
Constituent 1
impurity 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley strain rats.
At the start of the main study the males weighed 140 159g, and the females 137 - 160g, and were approximately five to eight weeks old.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- NA
- Doses:
- single dose: 2000 mg/kg
- No. of animals per sex per dose:
- 5 female
5 male - Control animals:
- no
- Details on study design:
- NA
- Statistics:
- NA
Results and discussion
- Preliminary study:
- NA
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study.
- Gross pathology:
- NA
- Other findings:
- Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
There were no deaths.
No signs of systemic toxicity were noted during the study.
All animals showed expected gain in bodyweight during the study.
No abnormalities were noted at necropsy. - Executive summary:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
There were no deaths.
No signs of systemic toxicity were noted during the study.
All animals showed expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
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