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EC number: 440-930-8 | CAS number: 330198-48-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 20, 2001 till August 17, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according OECD Guideline 471 (Bacterial Reverse Mutation Assay) under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ZP-TIX 1014
- IUPAC Name:
- ZP-TIX 1014
- Details on test material:
- Identity: ZP-TIX 1014
Batch: NW-01-028
Purity > 99%,
Appearance: Solid
Expiration date: 30.12.2001
Stability in Solvent: not indicated by the sponsor
Storage: At room temperature
Color: white
Constituent 1
Method
- Target gene:
- uvrB
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal activation (Wistar rat , Phenobarbital/ß-Naphthoflavone)
- Test concentrations with justification for top dose:
- The test item was tested at the following concentrations:
33; 100; 333; 1000; 2500; 5000 µg/plate - Vehicle / solvent:
- The test item was dissolved in DMSO (purity > 99%, Merck, D-64293 Darmstadt).
The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: 2-aminoanthracene, 4-nitro-o-phenylene diamine, methyl methane sulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Testsolution, S9 mix or S9 mix substitution buffer, bacteria suspension were mixed. After pre incubation overlay agar was added to each tube. The mixture was poured on minimal agar plates.
DURATION
Preculture period: 4h incubation in water bath (37°C)
Preincubation period: 60 min (37°C)
Exposure duration: 48h (in the dark, 37°C) plus 1h pre incubation
SELECTION AGENT (mutation assays): Histidine
NUMBER OF REPLICATIONS: 3
NUMBER OF EXPERIMENTS: 2
OTHER EXAMINATIONS:
regualar background growth in negative and solvent control
spontaneous reversion rates in the negative and solvent control - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA 102) or thrice (strains TA 1535 and TA 1537) the colony of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant - Statistics:
- A statistical analysis of the data is not required.
Results and discussion
Test results
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. The plates incubated with the test item showd normal backround growth up to 5000 µg/plate with and without S9 mix in all strains used.
No substantial increase in the revertant colony numbers of any of the five tester strains was observed following treatment with ZP-TIX 1014 at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border or biological relevance.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported , the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- No toxic effects, no substantial increase in revertant colony numbers of any of the five strains was observed following treatment with ZP-TIX 1014 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
- Executive summary:
This study was performed to investigate the potential of ZP-TIX 1014 to induce gene mutations according to the plate incorporation test and the pre-incubation test using Salmonella typhimurium strains TA1535, TA 1537, TA98, TA100, TA102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concnetration, including the controls, was tested in triplicate. The test item was tested at the following concentrations: 33;100;333;1000;2500 and 5000 µg/plate. No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation.
The plates incubated with the test item showd normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
No substantial increase in revertant colony numbers of any of the five strains was observed following treatment with ZP-TIX 1014 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showd a distinct increase of induced revertant colonies.
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