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Registration Dossier
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EC number: 606-460-4 | CAS number: 201855-65-4
Repeated dose toxicity: oral
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:
- 2 016
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
- 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
Constituent 1
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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