Registration Dossier
Registration Dossier
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EC number: 627-063-2 | CAS number: 1134960-41-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU/OECD-guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
- EC Number:
- 627-063-2
- Cas Number:
- 1134960-41-0
- Molecular formula:
- C6H5O5Na
- IUPAC Name:
- sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 animals, 3 animals/group
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test substance did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Treatment with the test substance did not cause any clinical signs during the 14 days observation period.
- Gross pathology:
- No macroscopic observations were seen in animals dosed at 2000 mg/kg bw and terminated on Day 14.
Any other information on results incl. tables
Mortality
BYI 02960-BCS-CL71543 (Na-CMTS) did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical observations
Treatment with BYI 02960-BCS-CL71543 (Na-CMTS) did not cause any clinical signs during the 14 days observation period.
Body weight and body weight gain
Body weight and body weight gain of BYI 02960-BCS-CL71543 (Na-CMTS) treated animals showed no indication of a treatment-related effect.
Macroscopic Findings
No macroscopic observations were seen in animals dosed at 2000 mg/kg bw and terminated on Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
The test substance is non-toxic after acute oral administration at dose level of 2000 mg/kg bw.
The study result triggers the following classification/labelling:
- EU Directive 1999/45/EC (as amended): none
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 4) 2011: unclassified
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