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EC number: 635-156-4 | CAS number: 109293-98-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1989-09-20 to 1989-10-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted with a structural analogous read-across substance (free acid of the registered substance) in compliance to GLP and similar but not in accordance with current guidelines (recommended strain E.coli WPS or TA102 not included). Please refer to IUCLID section 13 for read-across justification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- recommended strain E.coli WPS or TA102 not included
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diflufenzopyr
- IUPAC Name:
- Diflufenzopyr
- Reference substance name:
- 109293-97-2
- EC Number:
- 600-910-3
- Cas Number:
- 109293-97-2
- IUPAC Name:
- 109293-97-2
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S 9 mix ( obtained from Aroclor induced rat liver)
- Test concentrations with justification for top dose:
- 333, 557, 1000, 3330, 6670, 10000 µg/plate
- Vehicle / solvent:
- - Vehicle used: DMSO, purity > 99 %
- Justification for choice of solvent/vehicle: Solubility
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation: TA98 and TA1538: 2-nitrofluorene, TA100 and TA 1535: sodium azide, TA1537 ICR-191; without metabolic activation 2-aminoanthracene
- Remarks:
- with metabolic activation: TA98 and TA1538: 2-nitrofluorene, TA100 a nd TA 1535: sodium azide, TA1537 ICR-191; without metabolic activation 2-aminoanthracene
- Details on test system and experimental conditions:
- A dose rangefinding study was performed using tester strain TA100 both in the presence and absence of microsomal enzymes. A minimum of ten dose levels of test article were tested (one plate per dose). The dose rangefinding study was performed using the same methodology as was used for themain assay. Cytotoxicity in this study is detectable as a decrease in the number of revertant colonies per plate and/or a thinning or disappearance of the bacterial background lawn. Routinely, the maximum dose selected to be tested in the mutagenicity assay should demonstrate cytotoxicity if possible.
Two independent test with three plate replications were performed on all strains with and without metabolic activation.
METHOD OF APPLICATION: Plate incorporation.
Duration
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
Colony formation - Evaluation criteria:
- Tester Strains TA98 and TA100
For a test article to be considered positive, It must cause at least a 2-fold increase in the mean revertants per plate of at least one tester strain over the mean vehicle control value for that tester strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article.
Tester Strains .TA1535, TA1537 and TA1538
For a test article to be considered positive, it must cause at least a 3-fold increase in the mean revertants per plate of at least one tester strain over the mean vehicle control value for that tester strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article. - Statistics:
- Not applicable
Results and discussion
Test results
- 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:
- cytotoxicity
- Remarks:
- slightly reduced background lawn in the highest concentration only in the absence of S 9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Dose range-findinq Study
Dose levels to be tested in the mutagenicity assay were selected based on the results of the dose range finding study conducted on the test article using tester strain TA100 in both the presence and absence of S9 (one plate per dose). Ten dose levels of test article, from 10000 to 10.0 µg per plate were tested. No cytotoxicity was observed in either the presence or absence of S9 as evidenced by no observed decrease in the number of revertants per plate. A slight reduction in the background lawn was observed in the absence of S9 at the highest dose level tested, however, the background lawn was evaluated as normal at all dose levels in the presence of S9.
Main Mutation Assay
The results of the dose rangefinding study were used to select 6 doses to be tested in the mutagenicity assay. The dose levels selected for the mutation assay ranged from 10000 to 333 µg per plate both in the presence and absence of S9.
In the Experiment, all data were acceptable and no positive increases in the number of histidine revertants per plate were observed with any of the tester strains either in the presence or absence of S9. All criteria for a valid study were met. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
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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