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EC number: 228-973-9 | CAS number: 6381-77-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute Oral Toxicity: LD50 = >5000 mg/kg bw
Acute Dermal Toxicity: LD50 = >2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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.
- 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
- Species:
- rat
- Strain:
- other: albino
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The key study was the only study available and was assigned a Klimisch score of 2.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic information provided.
- Principles of method if other than guideline:
- Sodium erythorbate(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 signs of toxicity for 48 and 72 hrs and 14 days.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- test site was moistened with physiological saline just prior to dosing
- Details on dermal exposure:
- TEST SITE
- Area of exposure:Intact and abraded skin
- Type of wrap if used: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
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure area was cleaned by thorough wiping
- Time after start of exposure: After 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: no - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 animals
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No signs of toxicity were observed.
- Clinical signs:
- other: Beahavour was normal and no signs of toxicity were observed.
- Other findings:
- - 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.
- Consumption of feed and water were normal. - Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 was >2000 mg/kg bw in this study.
- Executive summary:
In an acute dermal toxicity, 6 rabbits were dermally exposed (intact and abraded skin; occlusive exposure) to 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone for 24 hours at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 = > 2000 mg/kg bw
Behaviour, body weight gain, and consumption of feed and water were normal, and no signs of toxicity were observed. 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The key study was the only study available and was assigned a Klimisch score of 2.
Additional information
Acute inhalation toxicity is waived as the test substance has very low vapor pressure and high melting point, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed. Both acute oral and dermal studies (basic methodological details provided) had a Klimisch score of 2 and the results from both studies are acceptable to use in the human health risk assessment.
Justification for selection of acute toxicity – oral endpoint
Only 1 key study available.
Justification for selection of acute toxicity – inhalation endpoint
The test substance has very low vapor pressure and high melting point, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.
Justification for selection of acute toxicity – dermal endpoint
Only 1 key study available.
Justification for classification or non-classification
Based on the available information in the dossier, the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.
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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