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EC number: 237-198-5 | CAS number: 13684-56-5
- 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:
- supporting study
- Study period:
- 1990-11-05 to 1991-03-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The test was conducted according to OECD TG 471. This guideline was revised in 1997 with new recommendations. Two were not meet in this test: Only strains with GC base pair at the primary reversion site were included in the assay which may not detect certain oxidising mutagens, cross-linking agents and hydrazines. 2- Aminoanthracene was used as the only indicator of the efficacy of the S9-mix. Each batch of the S9 should also be characterised with a mutagen that requires metabolic activation by microsomal enzymes, e.g., benzo(a)pyrene, dimethylbenzanthracene.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- See "Rationale for reliability incl. deficiencies" for more information
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Desmedipham
- EC Number:
- 237-198-5
- EC Name:
- Desmedipham
- Cas Number:
- 13684-56-5
- Molecular formula:
- C16 H16 N2 O4
- IUPAC Name:
- ethyl 3´-phenylcarbamoyloxycarbanilate
- Test material form:
- solid: particulate/powder
- Details on test material:
- The test material is Desmedipham but the purity has not been specified.
Constituent 1
- Specific details on test material used for the study:
- White powder, stored in the dark at ambient temperature.
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Livers of rats induced by the polychlorinated biphenyl mixture.
- method of preparation of S9 mix: Ice-cold 0.05 M phosphate buffer, pH 7.4, was added to the following pre-weighed reagents to give final concentrations in the S9 mix of:
NADP di-Na salt 4 mM
Glucose-6-phosphate di-Na salt 25 mM
MgCl2.6H2O 8 mM
KCl 33 mM
This solution was immediately filter-sterilised by passage through a 0.45 urn Millipore filter and mixed with the liver 9,000 g supernatant fluid in the following proportion:
co-factor solution 9 parts liver preparation 1 part
This combination of co-factors and liver preparation was called the S9 mix.
- quality controls of S9 (enzymatic activity, metabolic capability, total protein concentration) - Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 3333 and 10000 mg/plate. The dose levels used selected on the basis of the results of the toxicity test.
- Vehicle / solvent:
- DMSO:
Desmedipham technical and the positive control substances, except sodium azide, were dissolved in dimethylsulphoxide. Sodium azide was dissolved in sterile, ultra-pure water.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate.
- Number of independent experiments: 2.
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 2 days. - Evaluation criteria:
- A test article was considered positive if there was either a dose-related response or a reproducible effect in independent tests. A significant mutagenic response was recorded, if at least a doubling of the mean concurrent vehicle control values was observed in strains TA 1535, TA 1537, TA 1538 and TA 98 at some concentrations of the test substances, and a 1.5 fold increase over the control value in strain TA 100.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Slight toxicity to bacteria was observed at 10000 µg/plate with and without S9. Precipitation of the test substance was noted at 10000 mg/plate in all strains with and without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Very slight toxicity was also noted at 10000 mg/plate. Precipitation of the test substance was noted at 10000 mg/plate in all strains with and without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Very slight toxicity was also noted with and without S9 at 10000 mg/plate. Precipitation of the test substance was noted at 10000 mg/plate in all strains with and without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Very slight toxicity was also noted with and without S9 at 10000 mg/plate. Precipitation of the test substance was noted at 10000 mg/plate in all strains with and without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Slight toxicity to bacteria was observed at 10000 µg/plate with and without S9. Precipitation of the test substance was noted at 10000 mg/plate in all strains with and without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No mutagenic activity was observed in any of the 5 bacterial strains used, with or without S9.
Any other information on results incl. tables
See the Results' tables in the attched file in "Overall remarks, attachments"
Applicant's summary and conclusion
- Conclusions:
- Desmedipham was not mutagenic in the Salmonella typhimurium strains used in the study at doses up to 10000 µg/plate. The study was acceptable.
- Executive summary:
Desmedipham technical was tested for mutagenic activity in Salmonella tvphimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 at concentrations ranging from 33 µg to 10000 µg per plate.
The tests were conducted on agar plates in the presence and absence of induced rat liver preparation and co-factors (S9 mix) required for mixed-function oxidase activity.
Concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the S9 mix.
Desmedipham technical did not induce mutagenic activity in any of the 5 bacterial strains used, either in the presence or absence of S9 mix.
A slightly thin background lawn of microcolonies was noted in Salmonella typhimurium TA 1535 and TA 100 at 10000 µg per plate in the presence and absence of S9 mix. A thin lawn was noted in TA 1537, TA 1538 and TA 98 at 10000 µg per plate in the presence and absence of S9 mix.
Precipitation of the test substance was observed at 10000 µg per plate in all 5 bacterial strains, in both activation conditions.
It was concluded that Desmedipham technical was not mutagenic to Salmonella typhimurium when tested in dimethylsulphoxide at concentrations extending into the toxic range.
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