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EC number: 233-321-1 | CAS number: 10117-38-1
- 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 irritation / corrosion
Administrative data
- 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:
- guideline study with acceptable restrictions
- Remarks:
- Minor deviations with no effect on the results: - Purity and stability were not stated. - According to guideline, the observations should be made at 30-60 minutes and at 24, 48, and 72 hours after patch removal and not 24 hours, 48 hours and 72 days after start of exposure. - A modified Draize scoring system was used in this study. - According to the guideline the test substance should be moistened with water. In this study the test patch was moistend with water for application instead of the test substance. - The water supply was not unrestricted. - in the study report it was stated that observations were made at 30-60 minutes after patch removal. In the result table data were listed for an observation at 4-hours.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981-05-12
- Deviations:
- yes
- Remarks:
- , see "rationale for reliability"
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Potassium sulphite
- EC Number:
- 233-321-1
- EC Name:
- Potassium sulphite
- Cas Number:
- 10117-38-1
- Molecular formula:
- K2SO3
- IUPAC Name:
- potassium sulphite
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Potassium sulphite
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Savo; Med. Versuchstierzuchten GmbH; 7964 Kisslegg/Allgäu FRG
- Weight at study initiation: mean weight 2.56 kg (Individual weights of the three test animals:2.78 kg, 2.22 kg, and 2.68 kg)
- Housing: The animals were individually housed. The animals were housed in fully air-conditioned rooms. Cage made of stainless steel with wire mesh walk floors. Floor area: 40 cm X 51 cm. No bedding in the cages.Sawdust in the waste trays.
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH- 4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 ml tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study; same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A dose of 0.5 g of the unchanged test substance. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours; Readings of skin irritation at 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after the beginning of application.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
The fur of the rabbits was clipped at least 15 hours before the beginning of the study.The application area was 2.5 cm X 2.5 cm on the upper third of the back or flanks. The test patch (2.5 cm X 2.5 cm) was covered with a dose of 0.5 g of the unchanged test substance and has been moistened with aqua dest.. Test patches were secured in position with a porous dressing (four layers of absorbant gauze and porous bandage). The untreated skin sites of the same animals was used as negative control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with lutrol and lutrol/water (1:1).
- Time after start of exposure: At the end of the exposure period
SCORING SYSTEM: Modified Draize scoring system
Evaluation of erythema (R) and oedema (ED):
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The readings were made 24 h, 48 h and 72 h after the beginning of application
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The readings were made 24 h, 48 h and 72 h after the beginning of application
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The readings were made 24 h, 48 h and 72 h after the beginning of application
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The readings were made 24 h, 48 h and 72 h after the beginning of application
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The readings were made 24 h, 48 h and 72 h after the beginning of application
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was observed in two animals at the 4-hour reading, which had disappeared at the 24 hour reading.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
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