Registration Dossier
Registration Dossier
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EC number: 253-057-0 | CAS number: 36483-57-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- EC Number:
- 253-057-0
- EC Name:
- 2,2-dimethylpropan-1-ol, tribromo derivative
- Cas Number:
- 36483-57-5
- Molecular formula:
- C5H9Br3O
- IUPAC Name:
- 3-bromo-2,2-bis(bromomethyl)propan-1-ol
- Details on test material:
- Identification: FR-513
Mol. formula: C5H9Br3O
Mol. Weight: 324.92
CAS #: 36483-57-5
Description: White flakes
Batch: 039084 (taken from label)
Composition: Tribromoneopentyl alchohol 97%, Dibromoneopentyl glycol < 0.1%
Storage: At room temperature in the dark
Stability under storage conditions: Stable
Constituent 1
Method
- Target gene:
- not relevant
Species / strain
- Species / strain / cell type:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-1254 induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Range finder test: control: (DMSO), 33, 100, 333, 1000, 3250µg/ml (-S9-mix) (3hr, 24 hr, 48 hr exposure; 24hr, 24hr,48 hr fixation) ; control (DMSO), 33, 100, 333, 1000, 3250µg/ml (+S9-mix) (3hr exposure; 24hr fixation)
Main test 1: control (DMSO), 100, 333, 666, 1000, 1250, 1500, 2000 µg/ml, MMC-C (0.5 µg/ml) (-S9-mix)(3hr exposure, 24 hr fixation); control (DMSO), 100, 333, 666, 1000, 1250, 1500, 2000 µg/ml, CP (15 µg/ml) (+S9-mix)(3hr exposure, 24 hr fixation)
Main test 1A: control (DMSO), 100, 333, 666, 1000, 1050, 1100, 1150, 1200 µg/ml, MMC-C (0.5 µg/ml) (-S9-mix)(3hr exposure, 24 hr fixation); control (DMSO), 100, 333, 666, 1000, 1050, 1100, 1150, 1200 µg/ml, CP (15 µg/ml) (+S9-mix)(3hr exposure, 24 hr fixation)
Main test 1B: control (DMSO), 333, 1000, 1010, 1020, 1030, 1040, 1050 µg/ml, CP (15 µg/ml) (+S9-mix)(3hr exposure, 24 hr fixation)
Main test 1C: control (DMSO), 333, 666, 1000 µg/ml, MMC-C (0.5 µg/ml) (-S9-mix)(3hr exposure, 24 hr fixation); control (DMSO), 333, 666, 1000, 1020, 1050, 1100, 1200 µg/ml, CP (15 µg/ml) (+S9-mix)(3hr exposure, 24 hr fixation)
Main test 1D: control (DMSO), 100, 300, 600, 800, 1000, 1020, 1030, 1050, 1100 µg/ml, CP (15 µg/ml) (+S9-mix)(3hr exposure, 24 hr fixation)
Main test 2: control (DMSO), 17, 66, 100, 126, 150, 200 µg/ml, MMC-C (0.2 µg/ml) (-S9-mix)(24 hr exposure, 24 hr fixation); control (DMSO), 1, 3, 10,17, 66, 100 µg/ml, MMC-C (0.1 µg/ml) (-S9-mix)(48 hr exposure, 48 hr fixation); control (DMSO), 100, 167, 666, 1000, 1250, 1500, 2000 µg/ml, CP (15 µg/ml) (+S9-mix)(3 hr exposure, 3 hr fixation)
Main test 2: control (DMSO), 17, 66, 100, 126, 150, 200 µg/ml, MMC-C (0.2 µg/ml) (-S9-mix)(24 hr exposure, 24 hr fixation); control (DMSO), 1, 3, 10,17, 66, 100 µg/ml, MMC-C (0.1 µg/ml) (-S9-mix)(48 hr exposure, 48 hr fixation)
Main test 2A: see in materials and methods* - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- Mytomycin (MMC-C) (-S9-mix)
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: (CP) + (S9-mix)
- Details on test system and experimental conditions:
- see attached document on test system and conditions
- Evaluation criteria:
- see attached document on data evaluation and statistical procedures
- Statistics:
- see attached document on data evaluation and statistical procedures
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cell lysis at 3250µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 100µg/ml, 1020 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: Peripheral human lymphocytes
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1100 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- see attached document on results
- Remarks on result:
- other: other: range finding test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
see attached document on tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive clastogenic in the presence and in the absence of metabolic activation
FR-513 was found to be clastogenic in the presence of metabolic activation and at the highest test substance concentration (1000 microgram/ml) in the absence of metabolic activation. FR-513 has the potential to disturb mitotic processes and cell cycle progression. - Executive summary:
Evaluation of the ability of FR-513 to induce chromosome aberrations in cultured peripheral human lymphocytes was conducted using appropriate guidelines such as OECD 473. The report describes the effect of FR-513 on the number of chromosome aberrations in cultures perpheral human lymphocytes in the presence and absence of a metabolic activation system. A range finder study was conducted which followed by several main tests.
It is concluded that the test was valid and under the experimental conditions FR-513 was found to be clastogenic in the presence of metabolic activation and at the highest test substance concentration (1000 microgram/ml) in the absence of metabolic activation. FR-513 has the potential to disturb mitotic processes and cell cycle progression.
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