Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 233-333-7 | CAS number: 10124-41-1
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Experimental work started on 21 July 2010 and was completed on 20 September 2010.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Ammonium thiosulphate
- EC Number:
- 231-982-0
- EC Name:
- Ammonium thiosulphate
- Cas Number:
- 7783-18-8
- Molecular formula:
- H3N.1/2H2O3S2
- Reference substance name:
- ammonium thiosulfate
- IUPAC Name:
- ammonium thiosulfate
- Details on test material:
- - Name of test material (as cited in study report): ammonium thiosulfate
- Molecular formula (if other than submission substance): (NH4)2S2O3
- Molecular weight: 148.2 g/mol
- Physical state: solid, white powder
- Storage condition of test material: stored at 15-25°C in the dark
Constituent 1
Constituent 2
Method
- Target gene:
- hprt
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 media containing 2.5 µg/mL Amphotericin B, 100 µg/mL Streptomycin, 100 units/mL Penicillin, 0.5 µg/mL Pluronic (ecxept for RPMI 20) and 0%, 10% or 20% (v/v) heat inactivatet horse serum for RPMI A, RPMI 10 and RPMI 20, respectively.
The master stock of L5178Y tk+/- mouse lymphoma cells originated from Dr Donald Clive, Burroughs Wellcome Co.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes; each batch of frozen cells was confirmed to be mycoplasma free.
- Periodically checked for karyotype stability: yes; each batch of frozen cells was purged of mutants.
- Periodically "cleansed" against high spontaneous background: yes
For each experiment, at least one vial was thawed rapidly, the cells diluted in RPMI 10 and incubated in a humidified atmosphere of 5% v/v CO2 in air. When the cells were growing well, subcultures were established in an appropriate number of flasks. - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Range-finder experiment:
- with and without S9-mix: 46.31, 92.63, 185.3, 370.5, 741 and 1482 µg/mL
Concentrations selected for the Mutation Experiments were based on the results of this cytotoxicity Range-Finder Experiment.
Experiment I:
- with and without S9-mix: 200, 400, 600, 800, 1000, 1200, 1350 and 1482 µg/mL
Experiment II:
- with and without S9-mix: 100, 300, 600, 900, 1100, 1300 and 1482 µg/mL
Cultures selected for mutation assessment:
Experiment I:
- with and without S9-mix: 200, 400, 600, 800, 1000, 1200, 1350 and 1482 µg/mL
Experiment II:
- with and without S9-mix: 300, 600, 900, 1100, 1300 and 1482 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: purified water
- Justification for choice of solvent/vehicle: Preliminary solubility data indicated that ammonium thiosulfate was soluble in water for irrigation (purified water) at concentrations up to at least 34.99 mg/mL.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- treatment with the vehicle (purified water) diluted 10 fold in the treatment medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitroquinoline-1-oxide; 0.1 and 0.15 µg/mL (dissolved in DMSO)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- treatment with the vehicle (purified water) diluted 10 fold in the treatment medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 2 and 3 µg/mL (dissolved in DMSO)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 hours at 37°C
- Expression time (cells in growth medium): 7 days during which the hprt mutation would be expressed: After the incubation period, cultures were centrifuged (200 g), washed and resuspended in RPMI 10. Cells were transferred to flasks for growth throughout the expression period or were diluted to be plated for survival (scoreable after 7 days).
- Selection time (if incubation with a selection agent): 12 to 14 days: At the end of the expression period, aliquots of cell suspension were placed into each well of 4 x 96 well microtitre plates (384 wells at 2 x 104 cells/well). Plates were incubated at 37ºC in a humidified incubator gassed with 5% v/v CO2 in air and wells containing clones were identified and counted.
SELECTION AGENT (mutation assays): 6-thioguanine (6TG)
NUMBER OF REPLICATIONS: 2
EVALUATION: wells containing clones were identified and counted
DETERMINATION OF CYTOTOXICITY
- Method: relative survival:
Treatment and post treatment dilution of cell cultures for the cytotoxicity Range Finder Experiment was as described for the Mutation Experiments. However, single cultures only were used and positive controls were not included.
Following treatment, cells were centrifuged (200 g) washed with tissue culture medium and resuspended. Cells were plated into each well of a 96 well microtitre plate for determination of relative survival. The plates were incubated at 37ºC in a humidified incubator gassed with 5% v/v CO2 in air for 7 days. Wells containing viable clones were identified by eye using background illumination and counted.
OTHER:
- Probable number of clones/well (P) = -ln (empty wells (without clones) /total of TW),
- Plating efficiency (PE) = P/No of cells plated per well,
- Percentage relative survival (% RS) = % RS = [PE (test)/PE (control)] x 100,
- Mutant frequency (MF) = [PE (mutant)/PE (viable)] x 10^6. - Evaluation criteria:
- For valid data, the test article was considered to induce forward mutation at the hprt locus in mouse lymphoma L5178Y cells if:
1. The mutant frequency at one or more concentrations was significantly greater than that of the negative control (p<0.05).
2. There was a significant concentration relationship as indicated by the linear trend analysis (p<0.05).
3. The effects described above were reproducible.
Results that only partially satisfied the assessment criteria described above were considered on a case-by-case basis. - Statistics:
- Statistical significance of mutant frequencies was carried out according to the UKEMS guidelines. The control log mutant frequency (LMF) was compared with the LMF from each treatment concentration and the data were checked for a linear trend in mutant frequency with test article treatment. These tests require the calculation of the heterogeneity factor to obtain a modified estimate of variance.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No statistically significant increases in mutant frequency were observed following treatment with ammonium thiosulfate at any concentration tested and there were no significant linear trends.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
Osmolality and pH measurements on post-treatment media were taken in the cytotoxicity Range-Finder Experiment.
- Effects of pH and osmolality: No marked changes in osmolality or pH were observed in the Range-Finder at the highest concentrations analysed (1482 µg/mL) as compared to the concurrent vehicle controls (individual data not reported).
RANGE-FINDING/SCREENING STUDIES: 6 concentrations were tested in the absence and presence of S9 ranging from 46.31 to 1482 µg/mL (equivalent to 10 mM at the highest concentration tested). The highest concentration analysed was 1482 µg/mL, which gave 103% and 65% RS in the absence and presence of S9, respectively.
COMPARISON WITH HISTORICAL CONTROL DATA: yes; comparison of controls with historical means of the positive control substances.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In Experiment I, 8 concentrations, ranging from 200 to 1482 g/mL, were tested in the absence and presence of S9. 7 days after treatment, the highest concentration analysed gave 107% and 95% RS in the absence and presence of S9 respectively.
In Experiment II, 7 concentrations, ranging from 100 to 1482 µg/mL, were tested in the absence and presence of S9. 7 days after treatment, the highest concentration analysed gave 68% and 107% RS, respectively. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that ammonium thiosulfate did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells when tested under the conditions employed in this study in the absence and presence of a rat liver metabolic activation system (S9). - Executive summary:
Ammonium thiosulfate was assayed for the ability to induce mutation at the hypoxanthine-guanine phosphoribosyl transferase (hprt) locus (6-thioguanine [6TG] resistance) in mouse lymphoma cells. The study consisted of a cytotoxicity Range-Finder experiment followed by two independent experiments, each conducted in the absence and presence of metabolic activation (S9).
The test article was formulated in water for irrigation (purified water). A 3 -hour treatment incubation period was used for all experiments.
In the cytotoxicity Range-Finder Experiment, 6 concentrations were tested in the absence and presence of S9, ranging from 46.31 to 1482 mg/mL (equivalent to 10 mM at the highest concentration tested). The highest concentration analysed was 1482 mg/mL, which gave 103% and 65% relative survival (RS) in the absence and presence of S‑9, respectively.
In Experiment I, concentrations, ranging from 200 to 1482 mg/mL, were tested in the absence and presence of S9. 7 days after treatment all concentrations in the absence and presence of S9 were selected to determine viability and 6TG resistance. The highest concentration analysed was 1482 mg/mL, which gave 107% and 95% RS in the absence and presence of S9 respectively.
In Experiment II, concentrations, ranging from 100 to 1482 mg/mL, were tested in the absence and presence of S9. 7 days after treatment, the highest concentration analysed to determine viability and 6TG resistance was 1482 mg/mL, which gave 68% and 107% RS in the absence and presence of S9, respectively.
Vehicle and positive control treatments were included in each Mutation Experiment.
In Experiments I and II no statistically significant increases in mutant frequency were observed following treatment with ammonium thiosulfate at any concentration tested in the absence and presence of S9 and there were no significant linear trends.
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.