Registration Dossier
Registration Dossier
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EC number: 405-040-6 | CAS number: 63500-71-0 CIS/TRANS-TIMO; FLOROL; FLOROSA
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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- EC Number:
- 405-040-6
- EC Name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- Cas Number:
- 63500-71-0
- Molecular formula:
- C10 H20 O2
- IUPAC Name:
- 4-methyl-2-(2-methylpropyl)oxan-4-ol
- Details on test material:
- - Analytical purity: >99%
- Lot/batch No.: S2066301
- Storage condition of test material: 4 °C in the dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle: aqueous 1 % methylcellulose
- Duration of treatment / exposure:
- single gavage
- Post exposure period:
- 24 hours + 48 hours (for negative control and high dose)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150, 300, 600 mg/kg bodyweight
Basis:
actual ingested
- No. of animals per sex per dose:
- five
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- mitomycin C (12 mg/kg bodyweight)
Examinations
- Tissues and cell types examined:
- bone marrow smears from femur
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
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
no evidence of causing chromosome damage
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