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EC number: 940-936-5 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 20, 2014 -
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and in compliance with OECD guideline 471.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Not applicable
- EC Number:
- 940-936-5
- Molecular formula:
- C4H12NCl.C4H12NOCl
- IUPAC Name:
- Not applicable
- Test material form:
- other: Halo Salt was prepared as a formulation in dimethylsulfoxide (DMSO) at a concentration of 50 mg/mL.
- Details on test material:
- - Name of test material (as cited in study report): Halo Salt
- Physical state: liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Al, Ca,Cr,Co,Cu,Fe,Pb,Mg,Ni,K,Na,Sn,Ti,Zn < 100 ppb
- Composition of test material, percentage of components: Tetramethylammonium Hydroxide 1.34 (wt.%), Available Chlorine 8.31 (wt.%), Stabilizer 0.12 (wt%)
- Lot/batch No.: 0000066680
- Storage condition of test material: Store in well-closed, light-resistant containers
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: The Salmonella tester strains have a deep rough mutation (rfa-) that causes the cell wall to be defective in the lipopolysaccharide coat resulting in increased permeability to large molecules.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: All tester strains have a DNA deletion that affects repair of ultraviolet light damage which greatly increases sensitivity in detecting mutagens.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 fraction
- Test concentrations with justification for top dose:
- The initial assay:
Halo Salt was tested at 25, 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate using the plate incorporation method
The confirmatory assay:
Halo Salt was tested at 100, 250, 500, 1000, 2500 and 5000 µg/plate using the preincubation method. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene, ICR-191 acridine
- Details on test system and experimental conditions:
- The study was conducted according to the OECD guideline 471.
- Evaluation criteria:
- Criteria for Positive Response:
The test item was considered positive for mutagenicity if it induced an increase of revertants per plate with increasing concentration. The increases should be at least two times the vehicle control background frequency for strains with high spontaneous levels (i.e., TA100) and three times for those with low spontaneous levels (TA1537, TA98, TA1535 and WP2 uvrA). These increases should be seen in at least two or more successive concentrations or the response should be repeatable at a single concentration.
Criteria for Negative Response:
The test item was considered to be negative for inducing mutagenicity if it did not induce a response which fulfills the criteria for a positive response.
Criteria for Equivocal Response
Cases which did not clearly fit into the positive or negative criteria may be judged equivocal. In these cases the Study Director, based on sound scientific judgment, may take additional factors into consideration in evaluating the test results. - Statistics:
- For each concentration level and for each condition, the mean revertant count and standard deviation (SD) were determined.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- The concentrations tested in the confirmatory assay were 100, 250, 500, 1000, 2500 and 5000 µg/plate using the preincubation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- The concentrations tested in the confirmatory assay were 100, 250, 500, 1000, 2500 and 5000 µg/plate using the preincubation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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 with metabolic activation
negative without metabolic activation
The test item was tested for mutagenic potential using in vitro bacterial reverse mutation test. The test substance did not exert mutagenic activity both in the presence and the absence of metabolic activation. - Executive summary:
The test item was tested for the mutagenic potential using in vitro bacterial reverse mutation test (Ames test)(corresponding to the OECD No. 471). A preliminary range-finding assay was performed using four strains of Salmonella typhimurium (TA100, TA1535, TA98 and TA1537) and one strain of E. Coli (WPuvrA) up to a maximum dose of 5.0 mg/plate to determine the optimal non-toxic test dose. Precipitates were not observed in any strain either with or without metabolic activation. Cytotoxicity (i.e., reduction in the background lawn) was not observed in any strain with or without metabolic activation. Criteria for a negative response were met for all tester strains with and without metabolic activation.
The concentrations tested in the confirmatory assay were 100, 250, 500, 1000, 2500 and 5000 µg/plate using the preincubation method. Precipitates were not observed in any strain either with or without metabolic activation. Cytotoxicity (i.e., reduction in the background lawn) was not observed in any strain either with or without metabolic activation. Criteria for a negative response were met for all tester strains with and without metabolic activation.
The test result is used as a key value in the hazard assessment.
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