Registration Dossier
Registration Dossier
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EC number: 249-047-0 | CAS number: 28473-19-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- 23/06/2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- A QSAR approach has been applied to further demonstrate the lack of genotoxicity alerts across DIDS and read-across source substances. Further information is included in the Additional Information box under Materials and Methods.
Data source
Reference
- Reference Type:
- other: QSAR Output Report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OASIS alerts for in vitro and in vivo genotoxicity
- Principles of method if other than guideline:
- Multiple screening QSARs are available in the QSAR toolbox. These are detailed in the "Additional Information" box
- GLP compliance:
- no
- Type of assay:
- other: Multiple assay types are modelled, including AMES, chromosome aberration and micronucleus.
Test material
- Reference substance name:
- Diisodecyl sebacate
- EC Number:
- 249-047-0
- EC Name:
- Diisodecyl sebacate
- Cas Number:
- 28473-19-0
- Molecular formula:
- C26H50O4
- IUPAC Name:
- 1,10-bis(2-methylnonyl) decanedioate
- Test material form:
- liquid
Constituent 1
Results and discussion
Test results
- Key result
- Species / strain:
- mammalian cell line, other: Unspecified mammalian cell data
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- A QSAR approach was used to determine the genotoxic potential of diisodecyl sebacate, addressing the three key in vitro endpoints. The OECD QSAR toolbox was utilised for these. In conjunction with similar, comfirmatory data from read-across analogues, the QSARs demonstrate that diisodecyl sebacate is unlikely to cause gene mutations in either bacterial or mammalian cells, nor is it likely to cause chromosomal abberation.
- Executive summary:
A QSAR approach was used to determine the genotoxic potential of diisodecyl sebacate, addressing the three key in vitro endpoints. The OECD QSAR toolbox was utilised for these. In conjunction with similar, comfirmatory data from read-across analogues, the QSARs demonstrate that diisodecyl sebacate is unlikely to cause gene mutations in either bacterial or mammalian cells, nor is it likely to cause chromosomal abberation.
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.
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