Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Overall, (Q)SAR approaches are currently not well validated for repeated dose toxicity. (Guidance on IR/CSA, Section R7.5.4.1).
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
other: Predicted data
Title:
Unnamed
Year:
2016

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
61 mg/kg bw/day (nominal)
Based on:
other: Database: Repeated Dose Toxicity (HESS)
Basis for effect level:
other: Oral: gavage, rat

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
According to (Q)SAR modell: QSAR Toolbox, the predicted value indicated that finasteride saturated lactam causes several toxic effects (target organ toxicity). The result meets the requirement of STOT-RE Category 2.