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EC number: 228-973-9 | CAS number: 6381-77-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- 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:
- Final Report on the Safety Assessment of Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate, Erythorbic Acid, and sodium Erythorbate
- Author:
- F. Alan Andersen, Cosmetic Ingredient Expert Review Panel
- Year:
- 1 999
- Bibliographic source:
- International Journal of Toxicology 1999 18 (suppl. 3): 1-26
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male F344 rats (five per group, 6-week-old) were given 5% Sodium Erythorbate in feed for 22 weeks. Urine pH, osmolality and metabolic breakdown products were examined.
- GLP compliance:
- not specified
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
- Details on test material:
- - Name of test material (as cited in study report):Sodium erythorbate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 week old
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- 22 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5%
- No. of animals per sex per dose / concentration:
- 5 animals
- Control animals:
- yes, plain diet
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled (delete / add / specify): urine
Results and discussion
Main ADME resultsopen allclose all
- Type:
- metabolism
- Results:
- The rats eliminated totals of 203.3 ± 33.2 mg/100 mL erythorbic acid and 9.0 ± 5.1 mg/100 mL dehydroerythorbic acid during the study. Ascorbic acid and dehydroascorbic acid were not detected.
- Type:
- excretion
- Results:
- Test substance - Urine pH: 6.98 ±0.31; Urine osmolarity: 1378 ± 277 mOsmol/kg. Basal diet alone - Urine pH: 6.31 ± 0.18 (p < 0.05); Urine osmolarity :1756 ± 200 mOsmol/kg H20
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Urine pH was 6.98 ±0.31, which was significantly different from that of rats given basal diet alone (6.31 ± 0.18; p < 0.05). Urine osmolarity also differed significantly from controls; osmolarity was 1378 ± 277 mOsmol/kg H20 in rats given Sodium Erythorbate and 1756 ± 200 mOsmol/kg H20 in rats of the control group. Crystals were detected in urine of rats given basal diet and Sodium Erythorbate or basal diet alone.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The rats eliminated totals of 203.3 ± 33.2 mg/100 mL erythorbic acid and 9.0 ± 5.1 mg/100 mL dehydroerythorbic acid during the study. Ascorbic acid and dehydroascorbic acid were not detected.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
- Executive summary:
In a dietary study, 3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was administered to male F344 rats (five per group) at dose levels of 5% for 22 weeks.
The rats eliminated totals of 203.3 ± 33.2 mg/100 mL erythorbic acid and 9.0 ± 5.1 mg/100 mL dehydroerythorbic acid during the study. Ascorbic acid and dehydroascorbic acid were not detected. Urine pH was 6.98 ±0.31, which was significantly different from that of rats given basal diet alone (6.31 ± 0.18; p < 0.05). Urine osmolarity also differed significantly from controls; osmolarity was 1378 ± 277 mOsmol/kg H20 in rats given Sodium Erythorbate and 1756 ± 200 mOsmol/kg H20 in rats of the control group. Crystals were detected in urine of rats given basal diet and Sodium Erythorbate or basal diet alone.
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