Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
December 2018
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

Data source

Reference
Title:
T.E.S.T (Toxicity Estimation Software Tool) v4.2.1
Year:
2016
Bibliographic source:
Model developed by U.S. EPA/National Risk Management Research Laboratory/Sustainable Technology Division

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SMILES: CCOC(=O)CC(=O)OCC(=O)OCC

Results and discussion

Test results
Key result
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
The estimated data for 2-ethoxy-2-oxoethyl ethyl malonate applying TEST models for Mutagenicity in bacteria was: Non-mutagenic. The prediction falls inside the applicability domain of the model and is considered reliable.
CLP criteria are not met.
Executive summary:

Regulatory purpose: This study was designed to generate estimated in silico (nontesting) data for Mutagenicity for 2-ethoxy-2-oxoethyl ethyl malonate to be used in the regulatory framework of REACH.

Predicted value: Non-mutagenic.