Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: oral, other
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:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: REACH guidance on QSARs R.6, May/July2008
GLP compliance:
not specified

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

Effect levels

Dose descriptor:
NOEL
Effect level:
97.1
Remarks on result:
other: Oral: gavage, rat

Target system / organ toxicity

Critical effects observed:
no
Organ:
not specified

Applicant's summary and conclusion

Conclusions:
According to (Q)SAR modells: QSAR Toolbox, the predicted value indicated that acetoxy-ad causes severe toxic effects (target organ toxicity). The result meets the requirement of STOT-RE Category 2.