Registration Dossier
Registration Dossier
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EC number: 435-990-7 | CAS number: 371921-34-5
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:
- From February 5 to May 3, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Yellow 981
- IUPAC Name:
- Yellow 981
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- PEG 400
- Details on exposure:
- - Total volume of administration: 10 ml/kg bw
- Duration of treatment / exposure:
- Single administration
- Frequency of treatment:
- Single administration
- Post exposure period:
- 24 or 48 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- 48 h preparation interval
- No. of animals per sex per dose:
- 5 males and 5 females per group (four treatment groups, one negative control group, one positive control group)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (40 mg/kg bw)
Examinations
- Tissues and cell types examined:
- Femoral erythrocytes
- Evaluation criteria:
- 1) Negative controls are in the range of historical control data (0.01 - 0.15 %; mean = 0.066 + 0.032 PCEs with micronuclei).
2) Positive controls are in the range of historical control data (0.91 - 2.975 %; mean = 1.644 + 0.446 PCEs with micronuclei).
3) > 80 % of animals are evaluable.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- at top dose
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Negative: did not induce micronuclei in bone marrow cells of the mouse, thus, the substance is non-mutagenic in the in vivo erythrocyte micronucleus test.
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