Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-004-2 | CAS number: 102-08-9
- 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:
- 05 January 2012 - 23 April 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3-diphenyl-2-thiourea
- EC Number:
- 203-004-2
- EC Name:
- 1,3-diphenyl-2-thiourea
- Cas Number:
- 102-08-9
- Molecular formula:
- C13H12N2S
- IUPAC Name:
- 1,3-diphenyl-2-thiourea
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- Experiments without S9 mix
The selected treatment-levels were 78.13, 156.3, 312.5, 625, 1250 and 2500 µg/plate for the first and second experiments.
Experiments with S9 mix
. 78.13, 156.3, 312.5, 625, 1250 and 2500 µg/plate for the first and second experiments,
. 312.5, 625, 937.5, 1250, 1875 and 2500 µg/plate for the third and fourth experiments. - Vehicle / solvent:
- - Vehicle used: dimethylsulfoxide
- Justification for choice: test item is soluble at 100 mg/mL in the vehicle and using a treatment volume of 50 µL/plate, the highest recommended dose-level of 5000 µg/plate is achievable.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 9-aminoacridine, 2-nitrofluorene, mitomycin C (-S9 mix); 2-anthramine, benzo(a)pyrene (+S9 mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
The first experiment (with and without S9 mix) and the second experiment without S9 mix were performed according to the direct plate incorporation method, contrary to the second, third and fourth experiments with S9 mix, which were performed according to the pre-incubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to six dose-levels of the test item (three plates/dose-level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
DURATION
- Preincubation period: 60 minutes at 37°C.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies and/or thinning of the bacterial lawn - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account.
- Statistics:
- no
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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertants for the vehicle and positive controls met the acceptance criteria. The study was therefore considered to be valid.
Since the test item was found poorly soluble in the preliminary test, the choice of the highest dose-level was based on the level of precipitate, according to the criteria specified in the international guidelines.
Experiments without S9 mix
The selected treatment-levels were 78.13, 156.3, 312.5, 625, 1250 and 2500 µg/plate for the first and second experiments.
A moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 1250 µg/plate.
In the first experiment, a moderate toxicity (thinning of the bacterial lawn) was noted at dose-levels of 1250 µg/plate in the strains TA 1535 and TA 1537, and at 2500 µg/plate in the TA 100 strain.
In the second experiment, a moderate toxicity (thinning of the bacterial lawn) was noted at 2500 µg/plate in the TA 98 strain.
No noteworthy toxicity was noted towards the strain TA 102 in either experiment.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five strains.
Experiments with S9 mix:
In the first experiment performed using the direct plate incorporation method, a moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 1250 µg/plate.
Using the pre-incubation method, a moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels >=1250 µg/plate, except for the strains TA 100 and TA 1537 in the second experiment where a moderate precipitate was observed at 1250 µg/plate only. In the fourth experiment, a strong toxicity (decrease in the number of revertants) was noted at 2500 µg/plate towards the strain TA 1537.
No noteworthy toxicity was noted towards the other strains used.
Noteworthy increases in the number of revertants were noted at 2500 µg/plate in the strains TA 1535, TA 1537 and TA 100 in the second experiment performed with S9 mix. These increases exceeded the threshold of 2-fold the vehicle control (2.6-fold the vehicle control for the strain TA 100) and of 3-fold the vehicle control (up to 30.3-fold the vehicle control for the strains TA 1535 and TA 1537). Two additional experiments were performed using the same experimental conditions (pre-incubation method) and a closer range of dose-levels to check the reproducibility and therefore the reliability of these increases. In these experiments, no increases in the number of revertants were noted at any of the dose-levels tested. Thus, the increases noted in the second experiment were not reproducible in two additional independent experiments. Consequently, they were not considered as biologically relevant.
Applicant's summary and conclusion
- Conclusions:
- The test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, in the presence or in the absence of a rat metabolizing system.
- Executive summary:
The objective of this study was to evaluate the potential of the test item to induce reverse mutation in Salmonella typhimurium.
The study was performed according to the international guidelines (OECD No. 471 and Council Regulation (EC) No. 440/2008 of 30 May 2008, Part B13/14 p. 248) and in compliance with the principles of Good Laboratory Practice.
Methods
The first experiment (with and without S9 mix) and the second experiment without S9 mix were performed according to the direct plate incorporation method, contrary to the second, third and fourth experiments with S9 mix, which were performed according to the pre-incubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to six dose-levels of the test item (three plates/dose-level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
Results
The test item was dissolved in dimethylsulfoxide (DMSO).
The number of revertants for the vehicle and positive controls met the acceptance criteria. The study was therefore considered to be valid.
Since the test item was found poorly soluble in the preliminary test, the choice of the highest dose-level was based on the level of precipitate, according to the criteria specified in the international guidelines.
Experiments without S9 mix
The selected treatment-levels were 78.13, 156.3, 312.5, 625, 1250 and 2500 µg/plate for the first and second experiments.
A moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 1250 µg/plate.
In the first experiment, a moderate toxicity (thinning of the bacterial lawn) was noted at dose-levels of 1250 µg/plate in the strains TA 1535 and TA 1537, and at 2500 µg/plate in the TA 100 strain.
In the second experiment, a moderate toxicity (thinning of the bacterial lawn) was noted at 2500 µg/plate in the TA 98 strain.
No noteworthy toxicity was noted towards the strain TA 102 in either experiment.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five strains.
Experiments with S9 mix
In the first experiment performed using the direct plate incorporation method, a moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels >= 1250 µg/plate.
Using the pre-incubation method, a moderate to strong precipitate was observed in the Petri plates when scoring the revertants at dose-levels >=1250 µg/plate, except for the strains TA 100 and TA 1537 in the second experiment where a moderate precipitate was observed at 1250 µg/plate only. In the fourth experiment, a strong toxicity (decrease in the number of revertants) was noted at 2500 µg/plate towards the strain TA 1537.
No noteworthy toxicity was noted towards the other strains used.
Noteworthy increases in the number of revertants were noted at 2500 µg/plate in the strains TA 1535, TA 1537 and TA 100 in the second experiment performed with S9 mix. These increases exceeded the threshold of 2-fold the vehicle control (2.6-fold the vehicle control for the strain TA 100) and of 3-fold the vehicle control (up to 30.3-fold the vehicle control for the strains TA 1535 and TA 1537). Two additional experiments were performed using the same experimental conditions (pre-incubation method) and a closer range of dose-levels to check the reproducibility and therefore the reliability of these increases. In these experiments, no increases in the number of revertants were noted at any of the dose-levels tested. Thus, the increases noted in the second experiment were not reproducible in two additional independent experiments. Consequently, they were not considered as biologically relevant.
Conclusion
The test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, in the presence or in the absence of a rat metabolizing system.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.