Registration Dossier
Registration Dossier
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EC number: 606-460-4 | CAS number: 201855-65-4
Genetic toxicity: in vitro
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:
- 2 015
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
- 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
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks on result:
- other: Database: Toxicity Japan MHLW
Any other information on results incl. tables
| Software | Database / Method | Endpoint | Predicted value | |
| Toxtree | In vitro mutagenicity (Ames test) alerts by ISS | Mutagenicity | No structural alerts were identified. | No alerts for S.typhimurium mutagenicity |
Applicant's summary and conclusion
- Conclusions:
- According to (Q)SAR modells: QSAR Toolbox, Toxtree, the predicted values indicated that cis-HPD-tartarate is not mutagen.
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