Registration Dossier
Registration Dossier
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EC number: 814-072-3 | CAS number: 77614-79-0
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Sep - 02 Nov 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted in 2016
- Deviations:
- yes
- Remarks:
- relative humidity in the animal room was out of range for a few hours on different days. The deviation did not compromise the outcome of the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Version / remarks:
- adopted in 1998
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 3,5-bis(difluoromethyl)-1H-pyrazole
- EC Number:
- 814-072-3
- Cas Number:
- 77614-79-0
- Molecular formula:
- C5H4F4N2
- IUPAC Name:
- 3,5-bis(difluoromethyl)-1H-pyrazole
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle/solvent used: polyethylene glycol (PEG 400)
- Justification for choice of solvent/vehicle: The vehicle was chosen due to its relative non-toxicity for the animals and its ability to formulate a suitable dosing preparation (solution).
- Amount of vehicle: 10 mL/kg bw - Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- single treatment
- Post exposure period:
- 24 h after treatment for solvent control, treatment groups and positive control
48 h after treatment for treatment high dose group
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 20 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- For 24 h sampling: 6 (solvent and positive controls), 6 (treatment groups)
For 48 h sampling: 6 (treatment high dose group) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide (CPA)
- Route of administration: oral gavage
- Doses / concentrations: 40 mg/kg bw, dosing volume 10 mL/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- indicated by a decreased PCE/NCE ratio and by clinical signs including partly closed eyes, eyelid closure, ruffled fur, reduced breathing and reduced spontaneous activity
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, the compound did not induce micronuclei in the bone marrow of male NMRI mice in vivo.
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