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EC number: 264-980-3 | CAS number: 64628-44-0
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-04-22 to 2002-08-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide
- EC Number:
- 264-980-3
- EC Name:
- 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide
- Cas Number:
- 64628-44-0
- Molecular formula:
- C15H10ClF3N2O3
- IUPAC Name:
- 3-(2-chlorobenzoyl)-1-[4-(trifluoromethoxy)phenyl]urea
- Test material form:
- solid: particulate/powder
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species and species justification: The study was carried out in rats, a rodent species recommended in the test guidelines. Healthy young adult SPF bred Wistar rats, strain Hsd Cpb:WU (SPF), from the experimental animal breeder Harlan-Winkelmann GmbH, Borchen (Germany), were used. Animals of this strain have been used at Bayer AG in toxicological studies for years. Historical data on their physiology, diseases and spontaneous alterations are available. The state of health of the strain is randomly checked regularly at the instance of the Laboratory Animal Services, Bayer AG, for the most important specific infectious pathogens. The results of these examinations are archived.
Acclimatization: The animals were acclimatized to the animal room conditions for at least 5 days before use.
Identification: Animals were identified by both individual color-marking and cage labels. All animals from this study were located on one cage-rack.
Randomization: Before the start of the study the health status of each animal was assessed. Animals were subsequently assigned to exposure groups at random.
Health status: Only healthy rats free of signs were used for this study. The animals were not vaccinated or treated with anti-infective agents either before their arrival or during the acclimatization or study periods. The females were nulliparous and not pregnant.
Age and weight: At the study start the variation of individual weights did not exceed ±10 per cent of the mean for each sex. Animals of the weight class used are approximately 2 months old and hence fulfill the criterion for young adults.
Animal housing: During the acclimatization and study periods the animals were housed singly in conventional Makrolon® Type II cages). Cages were changed twice a week while unconsumed feed and water bottles were changed once per week.
Bedding: Bedding consisted of type BK8/15 low-dust wood granulate The wood granulate was randomly checked for harmful constituents at the request of the Laboratory Animal Services, Bayer AG.
Animal rooms: All animals were housed in a single room. For reasons of space availability rats from other acute toxicity studies were housed in the same room, however mistakes in animal assignments were excluded by adequate spatial separation, clear cage labeling, and appropriate organization of all work procedures.
Room temperature: 22 ± 2 °C
Relative humidity:40 - 60 %
Dark/light cycle: 12 h/12 h; artificial light from 6.00 a.m. to 6.00 p.m.
Light intensity: Central European Time approximately 14 watt/m2 floor area
Ventilation: approximately 10 air changes per hour
The room humidity and temperature were continuously monitored and documented using a calibrated thermohygrograph. Occasional deviations from these conditions occurred, e.g. as a result of animal room cleaning, but these had no detectable influence on the outcome of this study.
Feeding: Ration consisted of a standard fixed-formula diet (KLIBA 3883 = NAFAG 9441 pellets maintenance diet for rats and mice; PROVIMI KLIBA SA, 4303 Kaiseraugst, Switzerland) and tap water (drinking bottles). Both food and water were available ad libitum. The pelletized feed was contained in a rack in the stainless-steel wire cage cover. The nutritive composition and contaminant content of the standard diet was checked regularly by random sampling by the Laboratory Animal Services, Bayer AG.
Water: Drinking quality tap-water (Drinking Water Decree of 05.12.1990, Bundesgesetzblatt [federal law gazette] part I, page 2612) was provided ad libitum in polycarbonate bottles containing approximately 300 ml (based on A. Spiegel and R. Gonnert, Zschr. Versuchstierkunde, 1_, 38 (1961) and G. Meister, Zschr. Versuchstierkunde, 7, 144-153 (1965)). The results of feed and water analyses are retained by Bayer AG.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Mass median aerodynamic diameter (MMAD):
- >= 3.7 - <= 6.6 µm
- Geometric standard deviation (GSD):
- ca. 2
- Remark on MMAD/GSD:
- With regard to the respirability of the aerosol generated internationally recognized recommendations such as of SOT (1992) were fulfilled at 2.108 mg/L (MMAD 3.7 µm, GSD ~2), but could not be fully achieved at 5.030 mg/L (MMAD 6.6 µm, GSD ~2).
- Details on inhalation exposure:
- Mode of exposure; Animals were exposed to the aerosolized test substance in Plexiglas exposure tubes applying a directed-flow nose-only exposure principle. Tubes were chosen that accommodated the animals size. These tubes were designed so that the rat's tail remained outside the tube, thus restrained-induced hyperthermia can be avoided. This type of exposure is preferable to whole-body exposure on scientific (Pauluhn, 1984) and technical reasons (rapid attainment of steady-state concentrations, no problems with regard to test atmosphere inhomogeneities, better capabilities to control all inhalation chamber parameters, easier cleaning of exhaust air, and lower consumption of test substance). Moreover, contamination of the fur can largely be avoided. The chambers used are commercially available (TSE, 61348 Bad Homburg) and the performance of this type of chamber has been published (Pauluhn, 1984; Pauluhn, 1988; Pauluhn, 1994).
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- The mean achieved solid aerosol concentrations (dust) were 2108 and 5030 mg/m3 air (2.108 and 5.030 mg/L).
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 2 weeks
- Body weights were measured before exposure, on days 3 and 7, and weekly thereafter. Individual weights are also recorded at death, if applicable.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, rectal temperature
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.03 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Mortality did not occur.
- Clinical signs:
- other: Group 3 / males: Piloerection Group 3 / females: Nostrils with red encrustations
- Body weight:
- Comparisons between the control and exposure groups did not reveal an effect on body weight gains which is considered to be of no toxicological relevance. The decrease of mean body weights in group 3 (females only) is causally related to the decreased weight gain of one rat towards the end of the 2- week post exposure period. This rat did not experience any other effect. Therefore, this finding is considered to be incidental.
- Gross pathology:
- Animals sacrificed at the end of the observation period: In rats exposed to the test compound macroscopic findings were unremarkable, in spite the findings that 2/5 of the males rats of group 3 had lungs displaying isolated dark-red foci.
- Other findings:
- Rectal temperature: Statistical comparisons between control animals with those in the exposure groups revealed statistically significant decreased body temperatures (females only). Overall, the magnitude of response was too small to be of any toxicological significance.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Exposure to the maximum technically attainable concentration of 5030 mg/m3 did not result in mortality or any clinical signs of concern. As far as mild and transient signs were observed in one rat only they were nonspecific and appear to be related to the high dust load. Necropsy findings were unremarkable. With regard to the respirability of the aerosol generated internationally recognized recommendations such as of SOT (1992) were fulfilled following exposure to 2108 mg/m3, i.e. the MMAD was < 4 µm (MMAD µm, GSD˜2). In summary, the test substance (solid aerosol) proved to have essentially no acute inhalation toxicity to rats.
- Executive summary:
A study on the acute inhalation toxicity of triflumuron (hereafter referred to as test substance) on rats has been conducted in accordance with OECD Guideline No. 403. Test procedures were adapted so as to comply also with the EU Directive 92/69/EEC and OPPTS 870.1300. Two groups of rats were nose-only exposed to a mean solid aerosol concentration (dust) of 2108 and 5030 mg/m3 air. Attempts were made so that aerosol generated was respirable to rats. The results can be summarized as follows:
LC50 inhalation (aerosol, 4 hr) >5030 mg/m3
NO(A)EL = 2108 mg/m3 air
Observations and Measurements: Exposure to the maximum technically attainable concentration of 5030 mg/m3 did not result in mortality or any significant clinical signs. Necropsy findings were unobtrusive. With regard to the respirability of the aerosol generated internationally recognized recommendations such as of SOT (1992) were fulfilled at 2108 mg/m3, i.e. the MMAD was < 4 urn (MMAD 3.7µm, GSD≈2) or could not be fully achieved at 5030 mg/m3, i.e. the MMAD was > 4µm (MMAD 6.6µm, GSD≈2). In summary, the test substance (solid aerosol) proved to have essentially no acute inhalation toxicity to rats.
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