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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
Skin irritation: Not irritating
Serious eye damage/eye irritation: Not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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
- Species:
- rabbit
- Strain:
- other: albino
- 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
- 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).
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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.
- Principles of method if other than guideline:
- Sodium erythorbate powder (100 mg) was instilled into the conjunctival sac of albino rabbits (10 male and 2 female). The eyes of half of the treated rabbits were rinsed after 5 seconds. Reactions were compared between rinsed and unrinsed eyes and the following irritation parameters were noted: iris, conjunctival redness.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Rinsed eyes: 5 Seconds
Unrinsed eyes: Continuous - Observation period (in vivo):
- 1hr, 24hr, 48hr
- Number of animals or in vitro replicates:
- 12 (10 male, 2 female)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: chemosis score was not specific, but the overall irritation score was recorded.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: conjunctivae score was not specific, but the overall irritation score was recorded.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: iris score was not specific, but the overall irritation score was recorded.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: cornea opacity score was not specific, but the overall irritation score was recorded.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.33
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.17
- Remarks on result:
- other: rinsed eyes
- Irritant / corrosive response data:
- Reactions were comparable in rinsed and unrinsed eyes, and were slight and transient in nature.
One hour after dosing, two of six unrinsed eyes had congestion of the iris, but the iris reacted normally to light. Varying degrees of redness were observed in the lids of all unrinsed eyes. Slight redness of the nictitating membrane or palpebral conjunctiva at the medial canthus was observed in two unrinsed eyes.
At one hour, 1+ iritis was observed in one rinsed eye. Five of six rinsed eyes had slight redness that was limited to only the nictitating membrane in three cases. At 24 hours, all eyes were normal, with the exception of one that had slight reddening of the conjunctiva at the medial canthus. All eyes, rinsed and unrinsed, were normal at 48 hours.
The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes) (COLIPA 1982). - Interpretation of results:
- not irritating
- Executive summary:
In a primary eye irritation study, 100 mg of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone powder was instilled into the conjunctival sac of albino rabbits (10 male and 2 female). The eyes of half of the treated rabbits were rinsed after 5 seconds. Animals were then observed for 2 days. Irritation was scored by the method of Draize.
One hour after dosing, two of six unrinsed eyes had congestion of the iris, but the iris reacted normally to light. Varying degrees of redness were observed in the lids of all unrinsed eyes. Slight redness of the nictitating membrane or palpebral conjunctiva at the medial canthus was observed in two unrinsed eyes.
At one hour, 1+ iritis was observed in one rinsed eye. Five of six rinsed eyes had slight redness that was limited to only the nictitating membrane in three cases. At 24 hours, all eyes were normal, with the exception of one that had slight reddening of the conjunctiva at the medial canthus. All eyes, rinsed and unrinsed, were normal at 48 hours. The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes).
In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone is not an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
An in vivo skin irritation study (basic methodological details provided) was available. Animals were exposed (abraded and intact skin) under occlusive conditions for 24 hours. Skin reactions were evaluated at 24h, 48h and 72 hrs after exposure and no scoring scale was indicated. One rabbit (abraded skin) had slight erythema at 24 hours that cleared by 48 hours. Based on the results from the in vivo study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was classified as non- irritating. The results from this study are acceptable to use in the human health risk assessment.
Serious eye damage/eye irritation:
An in vitro eye irritation study was not required as an in vivo study was available. The in vivo study (basic methodological details provided) was conducted according to an older test method and six albino rabbits were used for each treatment (rinsed and unrinsed). The CLP regulation does not provide criteria for the evaluation of such studies. The current US EPA/UN Recommendations were considered as indicated in ‘Guidance on the application of the CLP criteria’, version 3.0, November 2012. Transient reactions (iritis, redness) were noted in unrinsed and rinsed eyes. All eyes, rinsed and unrinsed, were normal at 48 hours. The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes). Based on these criteria, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone is not an eye irritant. The results from this study are acceptable to use in the human health risk assessment.
Justification for selection of skin irritation / corrosion endpoint:
Only 1 key study available
Justification for selection of eye irritation 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 classified for skin irritation/corrosion and does not need to classified for serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.
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