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EC number: 601-779-5 | CAS number: 121451-02-3
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 May 2000 (study initiation date)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guidelines
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 601-779-5
- Cas Number:
- 121451-02-3
- Molecular formula:
- C17H7Cl2F9N2O3
- IUPAC Name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid
- Details on test material:
- - Substance type: white solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 9 weeks of age (when exposed to the test material)
- Housing: Animals were housed in groups of 2-3 in stainless steel cages during acclimatisation. Animals were housed individually during exposure and the observation period.
- Diet: Pelleted rodent diet, ad libitum.
- Water: Water from the municipal supply, ad libitum.
- Acclimation period: Rats were acclimatised to test conditions at least 7 days prior to study initiation, and to nose cones for a single 2 hour period on the day preceding exposure.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Under controlled conditions.
- Humidity (%): Under controlled conditions.
- Photoperiod (hrs dark / hrs light): 12hr light/dark photoperiod.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Modified ADG nose-only chamber, 30 cm diameter x 60 cm height.
- Exposure chamber volume: 42 litres.
- Method of holding animals in test chamber: Animals were held in a chamber so that their nose was located in the exposure port.
- Source and rate of air: Compressed air (ambient temperature) was supplied at an approximate rate of 30 L/min, sufficient to provide 43 air changes per hour.
- System of generating particulates/aerosols: Dust aerosol of the test material was generated using a Jet Mill. A cyclone was placed between the dust generator and the chamber to further reduce the particle size of the aerosol in the chamber.
- Method of particle size determination: The aerodynamic particle size was determined twice during the exposure period through a six-stage cascade impactor by drawing samples, at a set rate, using a Sierra series 110 constant flow air sampler, through a vertical stainless steel tube which projected into the animal breathing zone. The mass median aerodynamic diameter and geometric standard deviation were determined for each sample as well as the average of both samples.
Samples were obtained at 65 and 195 minutes into the exposure time, at a sample rae of 3 L/min for 1 minute.
- Treatment of exhaust air: Air exiting the exposure chamber was passed through an absolute filter before the air was exhausted. The test material was not recycled.
- Temperature, humidity, pressure in air chamber: exposure was performed at room temperature, chamber temperature, humidity and airflow were recorded approximately every 30 minutes during the exposure period.
Mean values:
Chamber temperature: 19.5 ± 0.10 °C
Exposure room temperature: 19.7 ± 0.12 °C
Relative humidity: 40.3 ± 0.5 %
Chamber airflow: 30 L/minute
TEST ATMOSPHERE
- Brief description of analytical method used: The mass concentration of aerosol present in the chamber was determined gravimetrically five times during the exposure period. Samples were taken by drawing air, at a set rate, through a vertical stainless steel tube that projected into the animal breathing zone. Aerosol particles were collected on pre-weight 0.45 mircron TefSep, Teflon laminated 47 mm filters. The time-weighted average (TWA) exposure concentration was calculated from the gravimetric measurements.
Nominal concentrations were calculated based on the amount of test material fed into the generation system and the total chamber airflow.
- Samples taken from breathing zone: Yes.
TEST ATMOSPHERE
- Particle size distribution: Approximately 9 % of the total mass of particles were less than 1 micron in size and approximately 84 % were less than 6 microns in size.
- MMAD (Mass median aerodynamic diameter): The average MMAD of the aerosol particles was 3.86 microns (based on two determinations), with geometric standard deviation of 1.62. MMAD ranged from 1 to 4 µm. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- determined gravimetrically
- Duration of exposure:
- 4 h
- Concentrations:
- TWA 5.24 mg/L, nominal concentration 11.40 mg/L.
- No. of animals per sex per dose:
- Five per sex per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were weighted and examined prior to exposure. Animals were observed at least every 30 minutes during the exposure period and each working day during the post exposure observation period.
Observations included an evaluation of the fur, eyes, mucous membranes and respiration.
Behaviour pattern and nervous system activity were assessed by specific observation for tremors, convulsions, salivation, lacrimation and diarrhoea, lethargy and other signs of altered central nervous system function.
An additional daily observation and routine monitoring on weekends (and holidays) was limited to husbandry procedures required to ensure the availability of feed and water.
All surviving rats were weighed on test days 2, 4, 8, 11 and 15 during the post exposure observation period.
Detailed clinical observations were conducted on all animals once prior to the start of treatment and daily thereafter. This was conducted at approximately the same time each day and included cage-side, hand-held and open-field observations that were recorded categorically or using a explicitly defined scales.
- Necropsy of survivors performed: Yes, all rats were submitted for a complete gross necropsy examination on test day 15.
Necropsy included examination of the eyes with a microscope slide using fluorescent illumination. Tissues were not saved, and no histopathologic examination was performed. - Statistics:
- Mean and standard deviations were calculated for descriptive purposes for chamber concentration (mean only), animal room humidity, animal body weights, exposure room and chamber temperature, humidity and airflow. The range of the animal room temperature was reported.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.24 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occured during the study.
- Clinical signs:
- other: The only clinical effect noted during the exposure was soiled furcoat (faecal soiling). Following exposure (test day 1), treatment related clinical observations included perineal soiling (urine and/or faecal), extensive body soiling (urine and faecal), or
- Body weight:
- Mean body weight losses of approximately 5 % and 4 % were noted on test day 2 in male and females, respectively. The body weight of the rats exceeded the pre-exposure mean value by test day 8.
- Gross pathology:
- There were no visible lesions attributable to exposure noted in any rats exposed to the test material at the test day 15-scheduled necropsy.
Any other information on results incl. tables
Table 1: Individual Body Weights
Dose (mg/L) |
Animal Sex |
Animal No. |
Day of Test |
|||||
1 |
2 |
4 |
8 |
11 |
15 |
|||
5.24 |
Male |
2243 |
208.7 |
195.2 |
204.2 |
214.1 |
219.4 |
230.6 |
2244 |
207.9 |
199.0 |
207.6 |
219.5 |
227.2 |
235.5 |
||
2245 |
208.5 |
200.4 |
207.2 |
216.4 |
225.9 |
240.1 |
||
2246 |
213.1 |
200.6 |
208.7 |
222.6 |
232.9 |
245.4 |
||
2247 |
217.6 |
208.5 |
215.3 |
226.1 |
236.9 |
248.6 |
||
Mean |
211.2 |
200.7 |
208.6 |
219.7 |
228.5 |
240.0 |
||
SD |
4.2 |
4.8 |
4.1 |
4.8 |
6.7 |
7.3 |
||
Female |
2248 |
132.8 |
128.3 |
131.4 |
138.8 |
142.9 |
148.1 |
|
2249 |
133.6 |
128.8 |
132.5 |
136.6 |
140.3 |
145.4 |
||
2250 |
134.9 |
129.4 |
137.1 |
141.2 |
145.3 |
150.1 |
||
2251 |
137.8 |
132.3 |
135.1 |
139.9 |
142.7 |
148.0 |
||
2252 |
140.7 |
125.2 |
140.6 |
147.8 |
152.1 |
155.5 |
||
Mean |
136.0 |
130.8 |
135.3 |
140.9 |
144.7 |
149.4 |
||
SD |
3.3 |
2.9 |
3.7 |
4.2 |
4.5 |
3.8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the acute inhalation LC50 of the aerosolized test material in male and female Fischer 344 rats was greater than 5.24 mg/L air.
- Executive summary:
The acute inhalation toxicity of the test material was determined in an aerosol inhalation study performed under GLP conditions and in accordance with the standardised guidelines OECD 403, EPA OPPTS 870.1300, EU Method B.3, and Japan MAFF testing guidelines.
Five male and five female Fischer 344 rats were nose-only exposed to a concentration of 5.24 mg/L. The aerosol particle size distribution mass median aerodynamic diameter (MMAD) averaged 3.86 microns with an average geometric standard deviation of 1.62 microns. Approximately 9 % of the mean mass particles were less than 1 micron. Approximately 84 % of the mean mass particles were less than 6 microns.
All animals survived the 4-hour exposure as well as the 2-week post-exposure period. Treatment-related in-life effects observed following exposure included perineal soiling (urine and/or faecal), abdominal soiling (faecal), or extensive body soiling (urine and faecal). All animals appeared normal by test day 3. The mean body weights, for the male and female rats, were decreased by approximately 4 and 5 % on test day 2 respectively, and had exceeded pre-exposure mean values by test day 8. There were no visible lesions attributable to exposure noted in any rats exposed to the test material at the test day 15-scheduled necropsy.
Under the conditions of the test, the 4 hour acute inhalation LC50 of the aerosolised test material in male and female Fischer 344 rats was greater than 5.24 mg/L air.
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