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EC number: 231-890-0 | CAS number: 7775-14-6
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Deviations from guideline: - physical nature and purity of the test substance were missing - only three strains of bacteria were used - TA1538 is not a strain mentioned by the guideline - no historical control data - only one concentration was test in the plate test and two concentrations were tested in the suspension test - only duplicate testing (plate test) - duration of incubation was four days during the plate test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1997-07-21
- Deviations:
- yes
- Remarks:
- , please refer to the field "Rationale for reliability incl. deficiencies" above
- GLP compliance:
- no
- Remarks:
- GLP was not compulsory at time of study conduct
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): compound FDA 73-43 (sodium sulfite) (Allied Chemicals No. H028)
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- tissue homogenates were prepared from liver, lung and testes of mice (ICR random bred; adult males), rat (Sprague-Dawley; adult males), and primate (Macaca mulatta; adult males)
- Test concentrations with justification for top dose:
- Plate tests: 0.028%
Suspension tests: 2.5% and 5.0% - Vehicle / solvent:
- All tests were conducted in an aqueous environment.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- ethylmethanesulphonate
- other: Quinacrine or Quinacrine mustard & Dimethylnitrosamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate test & suspension test
1) Plate test
In the non-activation procedure, cells of the bacterial strains were spread over the surface of a minimal plate, and a measured amount of the test chemical was placed in the center of the test plate. In activation tests, the test chemical was added to the cells, and an aliquot of the mixture was spread on the surface of the test plate. The reaction mixture (0.1 mL; tissue homogenate from liver, lung, and testes of mouse, rat and primate) plus tissue extract was then spotted on the surface of the plate. All plates were incubated at 37°C for four days and then scored. Each compound was done in duplicate.
2) Suspension test
Non activation:
Log-phase bacteria of the indicator organisms were grown in complete broth, washed and resuspended in 0.9% saline to densities of 1 X 10^9 cells/mL. This constituted the working stock for tests of a group of test chemicals and their respective controls. Tests were conducted in 30 mL plastic tissue culture flasks. Cells plus appropriate volume(s) of the test chemical were added to the flasks to give a final volume of 2 mL. Solvent replaced the test chemical in the negative controls. Treatment was at 37°C for one hour for bacterial tests. All flasks were shaken during treatment. Following treatment, the flasks were set in ice. Aliquots of cells were removed, diluted in sterile saline (4°C) and plated on the appropriate complete media. Undiluted samples from flasks containing the bacteria were plated on minimal selective medium. Bacterial plates were scored after incubation for 48 hours at 37°C.
Activation:
Bacteria were grown and prepared as described in the non-activation tests except that the cell densities were increased approximately five-fold for working stock suspensions. Measured amounts of the test and control chemicals plus 0.25 ml of the stock cell suspension were added to a 30 mL plastic tissue homogenate (tissue homogenate from liver, lung, and testes of mouse, rat and primate). All flasks (bacteria) were incubated at 37°C with shaking. The treatment times as well as the dilutions, plating procedures and soring of the plates were the same as described for non-activation tests.
Following the specified incubation periods all population plates were scored by an automatic colony counter.
DETERMINATION OF CYTOTOXICITY
The toxicity for all chemicals were determined prior to screening.
Each chemical was tested for survival against strain TA 1537 over a range of doses (test compound: 0.1, 0.5, 1.0, 2.5, and 5.0%) to determine the 50% survival dose. Bacteria were tested in phosphate buffer, pH 7.4, for one hour at 37°C on a shaker. The 50% survival dose was determined from the survival curve and the 1/4 and 1/2 50% doses calculated.
If no toxicity was obtained for a chemical with a given strain, then a maximum dose of 5% (w/v) was used against the strain.
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- no data
- Statistics:
- Frequencies were mechanically calculated and double checked.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, and TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥0.1% concentration
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Additional information on results:
- Compound FDA 73-43, sodium sulfite, did not exhibit genetic activity.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The following results were obtained when determining the 50% survival level for the test compound:
Control: 100% survival
0.1% concentration: 19% survival
0.5% concentration: 6% survival
1.0% concentration: 0.5% survival
2.5% concentration: 0.8% survival
5.0% concentration: 0% survival
Applicant's summary and conclusion
- Conclusions:
- The test substance did not appear to be mutagenic under given test conditions.
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