Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
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

Test animals

Species:
rat

Results and discussion

Effect levels
Key result
Dose descriptor:
LD50
Effect level:
7 285.85 mg/kg bw
Remarks on result:
other: QSAR predicted value

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The estimated value for 2-ethoxy-2-oxoethyl ethyl malonate applying TEST models for LD50 (oral) was 7285.85 mg/kg bw (>2000 mg/kg bw). 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 acute oral toxicity in rat for 2-ethoxy-2-oxoethyl ethyl malonate to be used in the regulatory framework of REACH.

LD50 (oral) = 7285.85 mg/kg bw.