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Diss Factsheets
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EC number: 244-169-0 | CAS number: 21049-70-7
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reasonably well-documented paper on morphologic changes in the nasal cavity
Data source
Reference
- Reference Type:
- publication
- Title:
- Morphologic effects of a Sulfur (IV) aerosol on the nasal cavity of beagle dogs
- Author:
- Takenaka S, Fürst G, Heilmann P, Heini A, Heinzmann U, Karg E, Murray AB, Ruprecht L and Heyder J
- Year:
- 1 994
- Bibliographic source:
- Toxicology Letters 72: 145-150
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Eight beagle dogs (35 months of age) were continuously whole body exposed to a Metabisulphite aerosol of 1 mg/m³ (equivalent to 0.6 mg/m³ as SO2) for 290 days. The aerosol was generated from an aqueous 3.5 % solution of Disodium disulfite (Na2S2O5) adjusted to pH 7. Three dogs served as control. At the end of the exposure period, the animals were sacrificed and the nasal cavity was prepared for histological examination.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Disodium disulphite
- EC Number:
- 231-673-0
- EC Name:
- Disodium disulphite
- Cas Number:
- 7681-57-4
- IUPAC Name:
- disodium disulphite
- Details on test material:
- - Name of test material: Sodium metabisulfite (Disodium disulfite)
- Molecular formula: Na2S2O5
- Molecular weight: 190.1 g/mol
- Substance type: technical product
- Physical state: solid, white powder
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 35 months old
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- - The aerosol was generated by nebulization of an aqueous 3.5 % solution of Disodium disulfite (Na2S2O5) adjusted to pH 7.
- Details on exposure were reported in Karg et al. (1992) and Heyder et al. (1992).
References
- Karg E, Tuch T, Ferron GA, Haider B, Kreyling WG, Peter J, Ruprecht L and Heyder J (1992). Design, operation and performance of whole body chamber for long-term aerosol exposure of large experimental animals. Journal of Aerosol Science 23: 279-290.
- Heyder J, Beck-Speier I, Ferron GA, Heilmann P, Karg E, Kreyling WG, Lenz AC, Maier K, Schulz H, Takenaka S and Tuch T (1992). Early response of the canine respiratory tract following long-term exposure to Sulfur (IV) aerosol at low concentration. I. Rationale, design, methodology, and summary. Inhalation Toxicology 4: 159-174. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 290 days
- Frequency of treatment:
- Continuous exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1 mg/m³
Basis:
nominal conc.
- No. of animals per sex per dose:
- 8 animals in total (exposure group)
3 animals in total (control group) - Control animals:
- yes
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- All animals were sacrificed after the exposure period under deep anethesia.
GROSS PATHOLOGY
- Nasal cavity
HISTOPATHOLOGY
- The nasal cavity was prepared for histological examination.
- During fixation of the lung the nasal cavity was removed and flushed with fixative via the pharygeal isthmus.
- After complete fixation, the nasal cavity was decalcified with 13 % Formic acid.
- Cross sections of the nasal cavity were dehydrated in a graded series of alcohols and embedded in paraplat; deparaffinized sections were stained. - Statistics:
- no data
Results and discussion
Results of examinations
- Details on results:
- GROSS PATHOLOGY
- Macroscopic changes were observed in the upper posterior part of the nasal cavity of exposed dogs.
- Focal thickness of the turbinal wall was observed macroscopically.
HISTOPATHOLOGY: NON-NEOPLASTIC
- Histologic changes were observed in the upper posterior part of the nasal cavity of exposed dogs.
- Histological sections showed that the changes were limited to the respiratory mucosa.
- The changes were characterized by a thickened epithelial layer resulting from epithelial proliferation, by a decrease in secretory material, and by a moderate mononuclear cell infiltration in the subepithelial region.
OTHER FINDINGS
- The changes were attributed to the exposure to Metabisulfite although the aerosol was contaminated by a low concentration of SO2 (0.18 mg/m³).
Effect levels
- Dose descriptor:
- NOAEC
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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