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EC number: 416-600-4 | 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:
- 1993-07-12 to 1994-01-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 416-600-4
- EC Name:
- -
- Cas Number:
- 77703-56-1
- Molecular formula:
- C23H32N4O2
- IUPAC Name:
- 3-butyl-1-[4-({4-[(butylcarbamoyl)amino]phenyl}methyl)phenyl]urea
Constituent 1
- Specific details on test material used for the study:
- Analytical purity: >= 99.65 %
Lot/batch No.: 93.166
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- => his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA 1535, TA 100) and frameshift (TA 1537, TA 98, TA 1538) mutations.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 8 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 8 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulphoxyde (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, TA1537 without S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2-A)
- Remarks:
- TA98, TA100, TA1535, TA1537, TA1538 with S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 without S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- TA1535 without S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without S9-mix
- Details on test system and experimental conditions:
- Preliminary study:
A preliminary study is performed on one bacterial strain TA100 (or TA98), without metabolic activation, in order to evaluate the toxicity of the test article to bacteria.
Increasing concentrations of the test article are used; examples for which are as follows: 8 - 40 - 200 - 1000 - 5000 mg/plate. The highest dose is 5000 µg/plate if the formulation type allows this dose level to be reached. A minimum of 5 dose levels are used.
Each concentration is tested in duplicate. At the end of the incubation period, the plates are observed for signs of toxicity. The colonies which appears in the presence of the test article are counted and the intensity of the bacterial lawn examined. These observations are compared with those performed in the presence of the vehicle. The signs of toxicity (reduction in bacterial lawn or reduction of the number of colonies) are noted.
Main study:
Two studies are conducted, the second study being performed to confirm or to complement the results of the first one for example by using a closer range near to the top limit dose.
For each study, each concentration of the test article is tested in triplicate with and without metabolic activation on each bacterial strain.
Concentration of the test substance resulting in precipitation: 1000 µg/plate - Evaluation criteria:
- The test article will be considered to be clearly mutagenic if:
- The assay is valid
- The number of revertants in presence of the test article is greater than or equal to twice the number of revertants in the negative control at one dose level (the upper dose before toxicity) or more with a dose correlation
- The positive trends/effects are reproducible.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1538
- 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:
- NA
Any other information on results incl. tables
The test article PATE HAT was tested on 5 strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537, TA1538) with and without metabolic activation. A range of sub-toxic concentrations was determined in a preliminary study on the strain TA100 without metabolic activation.
Five concentrations (5000, 1000, 200, 40 and 8 µg/plate) were tested in triplicate on the strains mentioned above with and without metabolic activation. The results were confirmed in a second independent study, using a closer range near the top of limit dose (5000, 2500, 1250, 625 and 313 µg/plate). A negative control (vehicle) and a positive control (specific standard mutagen) were included in each study.
Conclusion: Under the experimental conditions employed, it can be concluded that the test article PATE HAT did not cause an increase in the number of revertants per plate of any of the tester strains used, either in presence or absence of a metabolic activation system in both of the two independent studies performed
Applicant's summary and conclusion
- Conclusions:
- HAT ISO was tested for mutagenic activity in the Ames-test with the bacterial strains S. typhimurium TA98, TA100,TA1535, TA1537, TA1538 with and without metabolic activation in two independent studies. No increase of the number of revertants per plate was observed. No classification and labelling for genetic toxicity is required according to Regulation 1272/2008/EC (CLP).
- Executive summary:
PATE HAT was tested on 5 strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537, TA1538) with and without metabolic activation.
Five concentrations (5000, 1000, 200, 40 and 8 µg/plate) were tested in triplicate on the strains mentioned above with and without metabolic activation. The results were confirmed in a second independent study, using a closer range near the top of limit dose (5000, 2500, 1250, 625 and 313 µg/plate). A negative control (vehicle) and a positive control (specific standard mutagen) were included in each study.
PATE HAT did not cause an increase in the number of revertants per plate of any of the tester strains used, either in presence or absence of a metabolic activation system in both of the two independent studies performed
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