Registration Dossier
Registration Dossier
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EC number: 434-540-7 | 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
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:
- micronucleus assay
Test material
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- No. of animals per sex per dose:
- 5
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
In conclusion, it can be stated that during the study described and under the experimental
conditions reported, the test item did not induce micronuclei as determined by the
micronucleus test with bone marrow cells of the mouse.
Therefore, FAT 40'576/A is considered to be non-mutagenic in this micronucleus assay.
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