Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 238-289-2 | CAS number: 14338-82-0
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:
- 2008-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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)
- Version / remarks:
- 440/2008/EC
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Dibutyl methylenedithiodi(acetate)
- EC Number:
- 238-289-2
- EC Name:
- Dibutyl methylenedithiodi(acetate)
- Cas Number:
- 14338-82-0
- Molecular formula:
- C13H24O4S2
- IUPAC Name:
- butyl 2-({[(2-butoxy-2-oxoethyl)sulfanyl]methyl}sulfanyl)acetate
- Test material form:
- other: liquid
- Details on test material:
- Lot#: 24080
assay: 96.21 area% GC-FID
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Exp 1: w/wo met.act.: 013, 025, 05., 1.0, 2.5, 5.0 µl/ml
Exp2: w/o met. act: 0.031, 0.063, 0.125, 0.5, 1.0, 2.5, 5.0µl/ml; w. met. act.: 1.0, 2.0, 3.0 4.0 5.0 µl/ml - Vehicle / solvent:
- DMSO (Solvent)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: Solvent
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 400 and 600 µl/ml in nutrient medium
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- 0.83µl/ml in nutrient medium
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: ATTC, CCL-93
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It can be stated that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the test material methylenbis(butl thioglycolate or MBTester) did not induce structural chromosomal aberrations in the used V79 chinese hamster cell line.
Therefore, thet material MBT is considered to be non -clastogenic in this chromosome aberration test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
