Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo, other
Remarks:
in vivo micronucleus QSAR
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
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

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Times v.2.27.19.13 in QSAR Toolbox
Toolbox prediction report is attached in IUCLID
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: Not applicable
- Smiles: OC1C{P-}(O)C{P-}(O)C{P-}(O)C{P+}(O)C{P-}1O
Specific details on test material used for the study:
SMILES: OC1C{P-}(O)C{P-}(O)C{P-}(O)C{P+}(O)C{P-}1O

Results and discussion

Test results
Key result
Genotoxicity:
negative
Remarks:
Mammalian erythrocytes and/or peripheral blood
Remarks on result:
other: no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
Negative
Executive summary:

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