Registration Dossier
Registration Dossier
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EC number: 429-300-3 | CAS number: 155601-30-2 PYRAZOL P5; PYRAZOLE DHE
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP complicance, not OECD guideline
Data source
Reference
- Reference Type:
- other: inquiry result from ECHA
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.11 (Säuger-Knochenmark zytogenetischer in vivo-Test, Chromosomenanalyse)
- GLP compliance:
- yes
- Type of assay:
- other: in vivo mammalian bone marrow cytogenetic test
Test material
- Reference substance name:
- 1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
- EC Number:
- 429-300-3
- EC Name:
- 1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
- Cas Number:
- 155601-30-2
- Molecular formula:
- C5H12N4O5S
- IUPAC Name:
- 1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Aqua dest.
- No. of animals per sex per dose:
- Male: 100 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 200 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 400 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 150 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 300 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 600 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Results and discussion
Test results
- Toxicity:
- yes
- Remarks:
- 400 mg/kg b.w.(males), 600 mg/kg b.w. (females) At these dosis toxic symptomes such as reduction of spontaneous activity, eyelid closure (only in females) and apathy occured.
- Additional information on results:
- Observations:
No statistically significant increase in the frequency of aberrant cells occurred after treatment with the test item as compared to the vehicle control.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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