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EC number: 205-126-1 | CAS number: 134-03-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12/2009 - 02/2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium ascorbate
- EC Number:
- 205-126-1
- EC Name:
- Sodium ascorbate
- Cas Number:
- 134-03-2
- Molecular formula:
- C6H8O6.Na
- IUPAC Name:
- sodium ascorbate
Constituent 1
- Specific details on test material used for the study:
- CAS number: 134-03-2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/ water 30/70
- Concentration:
- 5%, 10% or 25% (w/v) in ethanol/water (30/70)
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A calculation of the EC3 value was performed resulting in an EC3 value of 11.6% for the positive control substance.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 5 %
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 10 %
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 25 %
- Key result
- Parameter:
- EC3
- Value:
- < 3
- Remarks on result:
- other: A calculation of the EC3 value was not performed because no test concentrations produced a S.I. of 3 or higher.
Any other information on results incl. tables
No deaths occurred during the study period. Neither clinical signs on the ears of the animals nor systemic findings were observed during the study period.
The body weights of the animals, recorded at the start of acclimatisation, prior to the first application and prior to sacrifice, were within the range commonly recorded for animals of the strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not a skin sensitizer in this assay
- Executive summary:
The skin sensitising potential of Sodium Ascorbate Crystalline was examined in an OECD 429 guideline study under GLP conditions. Three groups of four female mice each were treated daily with the test item at concentrations of 5%, 10% and 25% (w/v) in ethanol/water (30/70) by topical application to the dorsum of each ear lobe for three consecutive days. A control group of four female mice was treated with the vehicle ethanol/water (30/70) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine, 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes were excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3HTdR measured in a ß-scintillation counter. All treated animals survived the scheduled study period. Neither clinical signs on the ears of the animals nor systemic findings were observed during the study period. The Stimulation Index (S.I.) was 11.6% for the positive control substance and less than 3% for any of the test item concentrations (Harlan, 2010).
Hence, the EC3 value was not reached even with the highest test substance concentration of 25%. Sodium ascorbate is therefore not a skin sensitizer and the GHS criteria for classification are not met.
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