Registration Dossier
Registration Dossier
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EC number: 269-323-4 | CAS number: 68223-93-8
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:
- 2009-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP incl. certificate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- acc. 440/2008 B.10
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Diammonium 2,2'-dithiodiacetate
- EC Number:
- 269-323-4
- EC Name:
- Diammonium 2,2'-dithiodiacetate
- Cas Number:
- 68223-93-8
- Molecular formula:
- C4H6O4S2.2H3N
- IUPAC Name:
- diammonium 2-[(carboxymethyl)disulfanyl]acetate
- Test material form:
- other: liquid, aqueous solution 48% w/w
- Details on test material:
- Name of test material as cited in the report: Diammonium dithidiglycolate 48%
Lot# 27845 DADTDG 48%
assay: 48.3 %w/w iodometric
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 29.1, 50.9, 89.1, 156.0, 273.0, 477.7, 835.9, 1462.9, 2560.0, 4480.0 µg/ml active ingredient
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
Results and discussion
Test results
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
It can be stated, that under experimental conditions reported, the test material did not induece structural cromosomal aberrations in human lymphocytes in vitro
Therefore diammonium dithiodiglycolate is considered to be non-clastogenic in this chromosome aberration test, when tested up to the highest required concentration.
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