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EC number: 944-003-3 | CAS number: -
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a bacterial reverse mutation assay (Ames Test) conducted according to OECD Guideline 471 under GLP conditions, the Reaction products of sodium sulphide, sulphur, carbon disulphide and potassium hydroxide (EC# 944-003-3) was not mutagenic, with or without metabolic activation with S9 mix, in any of the bacterial strains tested (TA 1535, TA 1537, TA 98, TA 100, and E. Coli). Further in vitro genetic toxicity testing is not technically feasible given the high pH of the substance as placed on the market and the technical limitations of the methods. Furthermore, at physiologically relevant pH, the substance will degrade to form carbon disulphide which is not classified as geneotoxic / mutagenic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Test Material ID: Reaction products of sodium sulphide, sulphur, carbon disulphide and potassium hydroxide (EC# 944-003-3)
Purity of Test Material: 100% (Note: the test material is placed on the market as 100% solution comprised of 92% water and 8% inorganics that cannot be seperated from the water)
pH of Test Material: >= 12.0 (as reported by the sponsor)
Solubility of Test Material: Soluble (as reported by the sponsor) - Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (5% v/v)
- Test concentrations with justification for top dose:
- Final Doses (ug/plate) 0; 1.58; 5.0; 15.8; 25; 50; 158; 500; 5000 with the top dose chosen as the OECD standard limit dose.
- Vehicle / solvent:
- Vehicle selection was based on existing information when available; if necessary, preliminary solubility trials were to be conducted and documented in the raw data. Generally, the vehicle will be steril water; if the test article is not found to be adequately soluble, other solvents (Such as DMSO) will be considered, followed by aqueous suspending agents (as as 1% methyl cellulose in water) an additional vehicle group may be included when appropriate.
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive control substance:
- other: ICR 191 Acridine
- Details on test system and experimental conditions:
- Each of the S. typhimurium and E. coli strains recieved for use on this study were accompanied by documentation that includes lot number, preperation, and expiration dates, and confirmation of phenotype. The tester strains have several features that make them more sensitive for the detection of mutations. The specificity of these strains has provided useful information on the types of mutations that are induced by mutagenic agents (Ames, et al., 1973). The bacterial strains were purchased from Molecular Toxicology, Inc. The initial experiment followed the plate incorporation method, in which the following materials were mixed and poured over the surface of a minimal agar plate: Standard volume of vehicle control, test substance solution, or positive control. 500uL S9 mix or substitution buffer. 100uL bacterial preparation (ST or EC). 2.0 mL overlay agar maintained at approximately 45 deg C.
- Rationale for test conditions:
- Intermediate and high doses, but not the limit dose, were reduced to account for the high pH of the test substance.
- Evaluation criteria:
- The results are cinsidered positive (i.e., indicative of mutagenic potential) if: The results for the test item show a substantial increase in revertant colony counts i.e., response MF >/= 2 for strains TA98, TA100, and WP2 uvrA or MF >/= 3 for strains TA1535 and TA1537, with mean value(s) outside the labratory historical control range. Otherwise results were considered negative. The increase must be dose related and/or reproducible, i.e., increases must be obtained at more than one experimental point (at leased one strain, more than one dose level, more than one occasion or with different methodologies).
- Statistics:
- Means and standard deviations were generated for appropriate quantitave data. Other statistical methods were used if appropriate.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Incomplete lawn at 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Incomplete lawn at 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Incomplete lawn at 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Incomplete lawn at 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- The Reaction products of sodium sulphide, sulphur, carbon disulphide and potassium hydroxide (EC# 944-003-3) was not mutagenic in bacterial cells, with and without metabolic activation.
- Executive summary:
In a bacterial reverse mutation assay (Ames Test) conducted according to OECD Guideline 471 under GLP conditions, the Reaction products of sodium sulphide, sulphur, carbon disulphide and potassium hydroxide (EC# 944-003-3) was not mutagenic, with or without metabolic activation with S9 mix, in any of the bacterial strains tested (TA 1535, TA 1537, TA 98, TA 100, and E. Coli).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No studies available.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Classification is not warranted. The substance is not expected to be mutagenic.
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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