Registration Dossier
Registration Dossier
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EC number: 237-487-6 | CAS number: 13814-97-6
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study conducted by GLP accredited lab according to OECD guideline method 474
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1988
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
- Reference substance name:
- Tin(II) bis(methanesulfonate)
- EC Number:
- 401-640-7
- EC Name:
- Tin(II) bis(methanesulfonate)
- IUPAC Name:
- tin(II) bis(methanesulfonate)
- Reference substance name:
- 53408-94-9
- EC Number:
- 610-996-4
- Cas Number:
- 53408-94-9
- IUPAC Name:
- 53408-94-9
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
- Details on exposure:
- after dose finding study the maximum tolerated dose was determined to be 1000mg/kg
- Duration of treatment / exposure:
- 72h
- Frequency of treatment:
- one single treatment at the beginng of the study
- Post exposure period:
- mice were killed at 24,48 and 72h after exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 5 male and 5 female mice , 50mg/kg of cyclophosphamide
Examinations
- Tissues and cell types examined:
- bone marrow from femur
- Details of tissue and slide preparation:
- femur dissected and aspirated with foetal calf serum and bone marrow smears prepared following centrifugation and re-suspention. The smears were air-dried, fixed in absolute methanol and stained in May-Grunwald/Giemsa
- Evaluation criteria:
- stained bone marrow smears were examinated at random using light microscopy at 1000x magnification.
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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