Registration Dossier
Registration Dossier
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EC number: 425-000-1 | CAS number: 61718-80-7
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:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to recommended guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver fraction (S9 Mix) induced by mixture of Phenobarbital Na and Beta Naphthoflavone
- Test concentrations with justification for top dose:
- Concentration range in the Exp.I (with metabolic activation): 17 ... 2610 µg/ml
Concentration range in the Exp.I (without metabolic activation): 17 ... 2610 µg/ml
Concentration range in the Exp.II (with metabolic activation): 163.1 ... 2610 µg/ml
Concentration range in the Exp.II (without metabolic activation): 163.1 ... 2610 µg/ml - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 0.5 %
- True negative controls:
- yes
- Remarks:
- culture medium
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO 0.5 %
- True negative controls:
- no
- Remarks:
- culture medium
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4-22 hours
Expression time:
About 50-80 hrs
Fixation time:
22 hours in the preliminary test
46 hours in the main test
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1491 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 652.5 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
In the PRELIMINARY TEST the exposure period were 4 h. with S9 mix, and 4 hrs and 22 hrs without S9 mix.
The test article was assayed at the following dosage levels of 17, 30, 52, 91, 159, 278, 487, 852, 1491 and 2610 mg/mL with S9 mix ( 4 hrs exposure periods); 81.6, 163.1, 326.3, 652.5, 1305 and 2610 mg/L without S9 mix (4 hrs exposure period); 25, 50, 100, 150, 200 and 300 without S9 mix
(22hrs exposure period).
On the basis of the mitotic index reduction the following doses were selected for metaphases analysis:
exposure period of 4 hours (with S9 mix) 487, 852, 1491 and 2610 mg/L;
exposure period of 4 hours (without S9 mix) 326.3, 1305 and 2610 mg/L. Exposure period of 22 h (without S9 mix) 150, 200 and 300 mg/L.
In the MAIN TEST the exposure periods were 4 h with and without S9 mix.
The test article was assayed at the dosage levels of 163.1, 326.3, 652.5, 1305 and 2610 mg/L with and without S9 mix.
On the basis of the mitotic index reduction the following doses were selected for metaphases analysis: 326.3, 652.5 and 1305 mg/L with and withoutS9 mix. - Remarks on result:
- other: strain/cell type: human lymphocytes
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for mutagenicity.
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