Registration Dossier
Registration Dossier
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EC number: 617-441-5 | CAS number: 83121-18-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 Mar 1988 to 17 March 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 25 April 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute 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-Han. Wistar-[rat]
- 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: 9 to 11 weeks
- Weight at study initiation: Males: 210 - 225 g, Females: 171 - 200 g
- Fasting period before study: 12 - 18 hours
- Housing: Groups of 5 in Makrolon type-3 cages with standard softwood bedding
- Diet: ad libitum, Pelleted standard Kliba 343, rat naintenance diet, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland
- Water: ad libitum, tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/viability: 4 times during test day 1 and daily during days 2-15. Body weights: on test days 1 (pre-administration), 8 and 15. Clinical signs and symptoms were examined 4 times during day 1 and daily during days 2-15.
- Necropsy of survivors performed: yes - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Symptoms of sedation, hunched posture and ruffled fur was observed in all test animals within the first 24 hours following application. No clinical signs were noted at later observation time points.
- Gross pathology:
- No macroscopic organ changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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