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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
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:
(-)-3R,4R-1-Benzyl-4-(4-fluorophenyl)-3-hydroxymethyl-piperide-L-dibenzoyl tartrate
EC Number:
606-460-4
Cas Number:
201855-65-4
Molecular formula:
C19H22FNO + C18H14O8 = C37H36FNO9
IUPAC Name:
(-)-3R,4R-1-Benzyl-4-(4-fluorophenyl)-3-hydroxymethyl-piperide-L-dibenzoyl tartrate
Test material form:
solid: particulate/powder

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
97.1 mg/kg bw/day (nominal)
Based on:
other: Database: Repeated Dose Toxicity HESS
Remarks on result:
other: Oral: gavage, rat

Target system / organ toxicity

Critical effects observed:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

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

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