Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
results derived from a (Q)SAR model, with limited documentation / justification
Justification for type of information:
QSAR prediction

Data source

Reference
Reference Type:
other: Predicted data
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: REACH guidance on QSARs R.6, May/July2008
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(15α)-3,17-Dioxoandrost-4-en-15-yl acetate
EC Number:
613-793-9
Cas Number:
65429-29-0
Molecular formula:
C21H28O4
IUPAC Name:
(15α)-3,17-Dioxoandrost-4-en-15-yl acetate
Test material form:
solid: crystalline
Details on test material:
Test item: acetoxy-adCas No.: 65429-29-0Batch No.: M64027NStorage: 15-30 °C, protected from light and wet

Results and discussion

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

Any other information on results incl. tables

Software Database / Method Endpoint   Predicted value
VegaNIC Skin Sensitisation model (CAESAR) Mutagenicity No structural alerts were identified. NON-mutagen
VegaNIC Mutagenicity SarPy model Mutagenicity No structural alerts were identified. NON-mutagen

Applicant's summary and conclusion

Conclusions:
According to (Q)SAR modell: VegaNIC, the predicted values indicated that acetoxy-ad is not mutagen.