Registration Dossier
Registration Dossier
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EC number: 424-250-9 | CAS number: -
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Yellow MGi 1301
- IUPAC Name:
- Yellow MGi 1301
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Deionised water
- Details on exposure:
- Deionised water was used as vehicle control. The volume administered orally was 20 mg/kg b.w.. 24 h and 48 h after a single administration of the test article the bone marrow cells were collected for micronuclei analysis.
Ten animals (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. 1000 polychromatic erythrocytes (PCE) per animal were scored for micronuclei. - Frequency of treatment:
- Single administration
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 670 mg/kg bw/day (nominal)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- 48 h preparation interval
- No. of animals per sex per dose:
- 5 males and 5 females per test group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide 40 mg/kg bw
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- After treatment with the test article the number of NCEs was not increased as compared to the mean value of NCEs of the corresponding vehicle control thus indicating that YELLOW MGi 1301 had no cytotoxic effectiveness in the bone marrow.
In comparison to the corresponding vehicle controls there was no enhancement in the frequency of the detected micionuclei at any preparation interval after administration of the test article and with any dose level used.
40 mg/kg b.w. cyclophosphamide administered per os was used as positive control which showed a statistically significant increase of induced micronucleus frequency.
Applicant's summary and conclusion
- Conclusions:
- Non mutagenic
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