Registration Dossier
Registration Dossier
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EC number: 228-973-9 | CAS number: 6381-77-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: 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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
- Principles of method if other than guideline:
- Sodium erythorbate powder (2000 mg/kg) was applied to the intact and abraded skin of six rabbits. Each test site was moistened with physiological saline just prior to dosing. After application of the test material, the exposure area was covered with a double layer of surgical gauze and a piece of rubber dam. The trunk of each rabbit was wrapped in a stockinette, which was secured to the body with tape. The dressings were removed after 24 hour, and the amount of residual sample and signs of localized irritation were noted. The exposure area was cleaned by thorough wiping, and the rabbits were observed for signs of toxicity for 48 and 72 hrs and 14 days.
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sodium Erythorbate
- Physical state: Powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- other: test site was moistened with physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- 2000 mg/kg
- Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 24hrs, 48hrs
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: edema score was not recorded.
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-6
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: no observed at 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-6
- Time point:
- 48 h
- Remarks on result:
- other: no observed at 48 hrs for No. 1-5, No. 6 was observed for fully reversible within 48 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Irritant / corrosive response data:
- A substantial amount of residual compound was observed 24 hours after dosing. No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight (1+) erythema at 24 hours that cleared by 48 hours (COLIPA 1982).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lacton is not a dermal irritant.
- Executive summary:
In a primary dermal irritation study, 6 rabbits were dermally exposed to 2000 mg/kg 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (test site moistened with physiological saline) to intact and abraded skin. Test sites were covered with an occlusive dressing for 24 hours.
No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight erythema at 24 hours that cleared by 48 hours. In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lacton is not a dermal irritant.
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