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Registration Dossier
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EC number: 617-441-5 | CAS number: 83121-18-0
Toxicological information
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 October 1983 to 17 October 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP statement dates to Dec 18, 1987 QA statement dates to Nov 21, 1983
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 617-441-5
- Cas Number:
- 83121-18-0
- Molecular formula:
- C14 H6 Cl2 F4 N2 O2
- IUPAC Name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: KFM: Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: males: 7 weeks, females: 9 weeks
- Weight at study initiation: males: 220 - 293 g, females: 191 - 206 g
- Fasting period before study: No
- Housing: The animals were caged in groups of 5 in Makrolon type-4 cages with wire mesh lids
- Diet: ad libitum (with the exception of the exposure period), pelleted standard Kliba 343, rat maintenance diet (Klingentalmuehle AG, CH 4303 Kaiseraugst /Switzerland)
- Water: ad libitum (with the exception of the exposure period), tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remark on MMAD/GSD:
- Particle size was measured twice 1 and 3 hours after exposure start. Approximately 38 % of the determined particles were within a size range of 1 to 7 microns.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the exposure chamber (H. Born & Co., Mechan. Werkstatt, CH 4313 Moehlin / Switzerland).
- Exposure chamber volume: 100 L
- Method of holding animals in test chamber: the rats were placed around the exposure chamber in separate radial polyvinylchloride tubes with their snouts and nostrils exposed to the aerosol only.
- System of generating particulates/aerosols: the test substance was supplied to the nozzle by a Grafix Exaktomat injector (Cerutti AG, Bern / Switzerland). The air flow was 1000 L/hr and air pressure was 3 atmospheres. The spray nozzle discharged into the air of the chamber.
- Method of particle size determination: Gravimetrical determination with the aid of a 4 stage cascade impactor (Casella Ltd., London/England) on selectron filters, pore size 0.2 µm and 25 mm in diameter (Schleicher and Schuell, Feldbach/Switzerland). The particle size distribution shows for each filter of the cascade impactor the portion in % of the weight of particle sediment.
- Temperature, humidity, pressure in air chamber:
Oxygen content in chamber air: A constant amount of 20 vol. % of oxygen was found to be inside the exposure chamber during the test period (measured with OXYCOM 25 D, Draegerwerk AG, Zurich/Switzerland).
Relative humidity of chamber air: The relative humidity of the chamber air varied between 26 and 32 % during the exposure period (measured with HM 14, VAISALA humidity indicator, Kuenzli Elektronik, Zurich/Switzerland)
Chamber temperature: The chamber temperature was found to be within 22.9 and 23.4°C during the exposure period (measured with Therm 3420, contact thermometer, Interstar AB, Zug/Switzerland)
TEST ATMOSPHERE
- Brief description of analytical method and equipment used:
Determination of exposure concentration: Gravimetrical determinations on selectron filters, pore size 0,2 µm and 50 mm in diameter (Schleicher and
Schuell, Feldbach/Switzerland). Air flow: 10 l/min., equal 1.25 meters/sec.
Aerosol particle size determination: Gravimetrical determination with the aid of a 4 stage cascade impactor (Casella Ltd., London/England) on selectron filters, pore size 0.2 µm and 25 mm in diameter (Schleicher and Schuell, Feldbach/Switzerland). Air flow: 17.5 L/min. (which is usually used) gives velocities through the 4 jets of 2.2, 10.2, 27.5, and 77 m/s, respectively.
The particle size distribution shows for each filter of the cascade impactor the portion in % of the weight of particle sediment.London/England)
- Samples taken from breathing zone: yes
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- measured 5 times during exposure.
- Duration of exposure:
- 4 h
- Concentrations:
- nominal concentration: 33 g/m³ air
measured concentration: 5.048 g/m³ air - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: 5 times during the first day and daily thereafter
Symptoms: 5 times during the first day and daily thereafter
Body weights: At days 1 (day of exposure), 8 and 15 of test
- Necropsy of survivors performed: yes
- Other examinations performed: concentration (5 times during exposure), particle size (twice during exposure), oxygen content, humidity and temperature (8 times during exposure) - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The LC50 was estimated without use of a statistical model.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 038 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Dyspnea and ruffled fur was observed in all rats, starting within 2 hours of exposure. All rats recovered within 2 days after starting the exposure.
- Body weight:
- The body weight gain was unaffected by the exposure procedure.
- Gross pathology:
- No pathologic changes were observed during the macroscopic examination of all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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