Registration Dossier
Registration Dossier
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EC number: 457-470-9 | CAS number: 407-64-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed in accordance with the corresponding OECD-/EU-testing guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.12 Mutagenicity (Micronucleus test) Regulation of Czech Ministry of Health No.251/1998 (identical with Method B.12 Commission Directive 84/449/EEC)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BioTest s.r.o., Konárovice, Česká republika
- Weight at study initiation: males 160-197 g; females; 130-160 g
- Diet (e.g. ad libitum): Standard diet Peletisovaná NOAH (Racio Břecbv)
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
250 mg/kg
Basis:
nominal in water
5 males & 5 females
- Remarks:
- Doses / Concentrations:
750 mg/kg
Basis:
nominal in water
5 males & 5 females
- Remarks:
- Doses / Concentrations:
1500 mg/kg
Basis:
nominal in water
5 males & 5 females
- No. of animals per sex per dose:
- 5 animals per sex and dose group
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamide was tested as positive control at a concentration of 25 mg/kg
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Total number of animals: 50 rats
- Positive control: Cyclophosphamide (dose 25 mg/kg)
- Negative control: Water - aqua for injection
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The aqueous solution of the test item was found to be non mutagenic in this test - Executive summary:
The assay was performed 2001 in compliance with GLP and according to Method B.12 Mutagenicity (Micronucleus test) Regulation of Czech Ministry of Health No.251/1998 (identical with: Method B.12 of 84/449/EEC). The test was performed on male and female Wistar rats at concentrations of 250, 750 and 1500 mg/kg. The test item showed neither cytotoxicity nor mutagenic effects.
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