Registration Dossier
Registration Dossier
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EC number: 228-973-9 | CAS number: 6381-77-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic information provided.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
- Principles of method if other than guideline:
- Ten fasted albino rats were administered >5000 mg/kg of sodium erythorbate in a 50% aqueous suspension. Clinical observations were noted at 3, 5 and 24 hrs post-dosing.
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone
- EC Number:
- 228-973-9
- EC Name:
- 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone
- Cas Number:
- 6381-77-7
- Molecular formula:
- C6H8O6.Na
- IUPAC Name:
- sodium (2R)-2-[(1R)-1,2-dihydroxyethyl]-4-hydroxy-5-oxo-2,5-dihydrofuran-3-olate
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Sodium Erythorbate
- Physical state: 50% aqueous suspension
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Clinical signs:
- other: The treated rats had soft, pasty stools within 3 hrs of dosing, followed in 2 hrs by marked diarrhea that persisted for 24 hrs.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was >5000 mg/kg bw in this study.
- Executive summary:
In an acute oral toxicity study, 10 fasted albino rats were given a single oral dose of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone in a 50% aqueous suspension at a doses of 5000 mg/kg bw.
Oral LD50 = > 5000 mg/kg bw
The treated rats had soft, pasty stools within 3 hrs of dosing, followed in 2 hrs by marked diarrhea that persisted for 24 hrs.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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