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EC number: 947-646-8 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17th July 2015 - 6th August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction Mass of Mixed Xylenes and Sulphur Monochloride
- IUPAC Name:
- Reaction Mass of Mixed Xylenes and Sulphur Monochloride
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch 4600058
- Purity test date: Not applicable; substnace is a UVCB substance
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment 1 - Plate incorporation method: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 micro grams/plate
Experiment 2 - Pre-incubation method: 15, 50, 150, 500, 1500 and 5000 micro grams/plate
The dose range for experiment 2 was determined from the results in experiment 1. Six dose concentrations were used to achieve four non-toxic dose levels and the potential toxic limit of the test item. - Vehicle / solvent:
- Acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (Experiment 1) and pre-incubation (Experiment 2)
DURATION
- Pre-incubation period: 20 minutes at 37°C
- Exposure duration: 48 hours at 37°C for both application methods.
- Expression time (cells in growth medium): N/A
- Selection time (if incubation with a selection agent): N/A
- Fixation time (start of exposure up to fixation or harvest of cells):N/A
NUMBER OF REPLICATIONS: 3 replicates at each dose - Evaluation criteria:
- All tester strains should exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
All tester strain cultures should be in the range 0.9 to 9x1^09 bacterial /ml.
Positive controls should be included to demonstrate the sensitivity of the tester strains and the integrity of the S9 mix. All positive controls should induce a marked increase in the frequency of revertant colonies with and without metabolic activation.
There should be a minimum of four non-toxic dose levels and no evidence of excessive contamination.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- 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:
- not specified
- 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:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, no increases in the frequency of revertant colonies was observed, the test material 'reaction mass of mixed xylenes and sulphur monochloride' was considered to be non-mutagenic.
- Executive summary:
The genetic toxicity of ‘reaction mass of mixed xylenes and sulphur monochloride was examined in a bacterial reverse mutation assay (Ames test) performed to GLP and in accordance with OECD 471 and EU method B.13/14. Salmonella Typhimurium strains TA1535, TA 1537, TA98 and TA100, along with Escherichia coli strain WP2uvrA, were tested with and without S9 rat liver fraction metabolic activation.
Two mutation tests were performed, Experiment 1 used the plate incorporation method, test substance concentrations of 1.5, 5, 15, 50, 150, 500, 1500 and 5000µg/plate were assessed. Experiment 2 was performed using the pre-incubation method at concentrations of 15, 50, 150, 500, 1500 and 5000 μg/plate. Positive and vehicle controls were also tested.
There was no visible reduction in the growth of the background bacterial lawn at any dose level either with or without the metabolic activation, using either the plate incorporation method or the pre-incubation method. A test item precipitate was observed at the 5000 µg dose , this observation did not prevent the scoring of revertant colonies.
There were no significant increases in the frequency of the revertant colonies at any dose level with or without the metabolic activation using either incorporation method.
All of the positive controls induced marked increases in the frequency of the revertant colonies confirming the sensitivity of the bacterial strains and the activity of the S9 mix.
Under the conditions of the test, the test item ‘reaction mass of mixed xylenes and sulphur monochloride’ was considered to be non-mutagenic.
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