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Toxicological information

Genetic toxicity: in vitro

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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:
2020
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

Constituent 1
Chemical structure
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

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.