Registration Dossier
Registration Dossier
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EC number: 813-142-0 | CAS number: 1417782-28-5
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-11-04 to 2014-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
- EC Number:
- 813-142-0
- Cas Number:
- 1417782-28-5
- Molecular formula:
- C15 H10 Cl F3 O2
- IUPAC Name:
- 1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: L85-76
- Expiration date of the lot/batch: October 01, 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Storage Stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: 185 - 194 g (mean 190.7 g)
- Fasting period before study: at least 16 hours
- Housing: Single housing
- Diet: ad libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum, tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: undiluted or 20 g/100 mL
- Amount of vehicle: 1.52 mL/kg bw if administered undiluted and 1.50 mL/kg bw at a dose of 300 mg/kg bw.
- Justification for choice of vehicle: Solution in corn oil Ph.Eur.
MAXIMUM DOSE VOLUME APPLIED: 1.52 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Request of the sponsor - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations daily; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in both 2000 mg/kg bw test groups and in the single 300 mg/kg bw test group.
- Clinical signs:
- Clinical signs in the first 2000 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 4 after administration. These findings were seen again in one animal on day 1, in another animal from hour 5 until day 1. Additionally cowering position was observed in one animal from hour 4 until hour 5 only.
Clinical signs in the second 2000 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 5. In one animal these findings persisted until study day 2 after administration.
Clinical signs in the single 300 mg/kg test group revealed in all animals impaired general state and piloerection from hour 2 until hour 3 or/and 5 after administration. - Body weight:
- The mean body weight of all test groups increased throughout the study period within the normal range.
- Gross pathology:
- There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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