Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The scientific validity of the (Q)SAR model has been established in accordance with the OECD Principles for (Q)SAR Model Validation.
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014

Materials and methods

Principles of method if other than guideline:
Times v.2.27.13 in QSAR Toolbox 3.2.0.103
Toolbox prediction report is attached in IUCLID.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SMILES:OCC(C(=O)NN=Cc1ccc(O)c(O)c1O)N{+}.Cl{-}

Results and discussion

Test results
Genotoxicity:
positive

Any other information on results incl. tables






Estimation method: SAR/(Q)SAR prediction
OUT OF DOMAIN

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
The prediction is positive.
Executive summary:

The Times model for in vivo micronucleus formation was used within the QSAR Toolbox. The prediction was positive. Additional supporting documentation is provided in the prediction report attached in IUCLID.