Registration Dossier
Registration Dossier
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- solid test substance was applied as a solution; humidity range (animal housing): 20-80 %
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2008-04-17
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium sulphite
- EC Number:
- 231-821-4
- EC Name:
- Sodium sulphite
- Cas Number:
- 7757-83-7
- IUPAC Name:
- disodium sulfite
- Details on test material:
- - Name of test material: Natriumsulfit wasserfrei food grade (E221)/(PRD30042389); (Sodium sulfite)
- Physical state: white solid
- Analytical purity: 98.1 %
- Batch No.: 83704888Q0
- Storage stability: stable under storage conditions
- Storage condition of test material: at room temperature; under N2; protected against humidity
- Homogeneity: the test substance was homogenous by visual inspection.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks old (males), approx. 12 weeks old (females)
- Weight at study initiation: animals of comparable weight (±20 % of the mean weight); mean weights: 255 g (males), 218 g (females)
- Housing: individually, in fully air-conditioned rooms in Makrolon type III cages. Bedding: H 15005-29; Ssniff Spezialitäten GmbH, 59494 Soest, Germany)
- Diet: VRF1(P); SDS (Special Diets Services), 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Enrichment: NGM E-022; ABEDD®LAB & VET Service GmbH, 1160 Wien, Austria
ENVIRONMENTAL CONDITIONS
- Temperature: 22–26 °C
- Relative humidity: 20–80 %
- Photoperiod: 12 hours dark / 12 hours light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 24 hours before administration the fur was clipped. Then a single application to the clipped epidermis (dorsal and dorsolateral parts of the trunk) was applied.
- % coverage: at least 10 % of the body surface (about 40 cm²)
- Type of wrap: covering of the application site with a semi-occlusive dressing (the bandage consisted of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG, Germany) for 24 hours, afterwards removal of the dressing
REMOVAL OF TEST SUBSTANCE
- Washing: the application site was rinsed with warm water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 10 mL/kg bw (application volume)
- Concentration: 20 g/100 mL
- Constant volume or concentration used: constant volume
- For solids, paste formed: no, a solution was used for application. The test substance preparation was produced for the application group shortly before application. The dose formulation was stirred continuously to ensure a homogeneous distribution of the test item in the vehicle.
VEHICLE: doubly distilled water - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Body weight determination: shortly before administration (day 0), weekly thereafter and on the last day of observation
- Signs and symptoms: recording of signs and symptoms several times on the day of application, at least once each workday for the individual animals
- Scoring of skin findings: individual readings 30–60 minutes after removal of the semi-occlusive dressing (day 1), as a rule weekly thereafter and on the last day of observation
- Mortality: a check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.
- Pathology: necropsy with gross-pathology examination on the last day of the observation period after sacrifice with carbon dioxide in a chamber with increasing concentrations over time
Assessment of skin reactions: The evaluation of skin reactions was performed according to Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States, Austin, Texas. Descriptions of any dermal findings not covered by this scale were recorded. - Statistics:
- The means and standard deviations were calculated by using MS Excel 2003.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: There was no mortality at the limit dose level.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical observations were noted. No local effects were observed.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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