Registration Dossier
Registration Dossier
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EC number: 239-473-5 | CAS number: 15454-75-8
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- Not specified
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source
- Justification for type of information:
- A read-across justification report (RAAF) will be added to Section 13 as soon as possible.
Data source
Reference
- Reference Type:
- other: OECD Toolbox QSAR Prediction
- Title:
- QSAR Toolbox prediction for single chemical
- Author:
- Anon.
- Year:
- 2 017
- Bibliographic source:
- OECD QSAR Toolbox v 4.1
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: REACH guidance on QSARs R.6. May/July 2006
- Deviations:
- not specified
- Principles of method if other than guideline:
- This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.
The outcome of the QSAR model is “Known precedent reproductive and developmental toxic potential”, if the chemical has a potential to cause toxicity. The corresponding category is displayed in the report generated for the obtained prediction.
The other prediction results are “Not known precedent reproductive and developmental toxic potential” if the toxic potential of the input chemical is not known, and “Not covered by current version of the decision tree” if the identified structural features are not objects of the tree. - GLP compliance:
- no
- Remarks:
- As no laboratory work took place, compliance with GLP is not required.
Test material
- Reference substance name:
- Bis(5-oxo-L-prolinato-N1,O2)zinc
- EC Number:
- 239-473-5
- EC Name:
- Bis(5-oxo-L-prolinato-N1,O2)zinc
- Cas Number:
- 15454-75-8
- Molecular formula:
- C10H12N2O6Zn
- IUPAC Name:
- (3'aR)-3,3',6,6'-tetraoxo-3a,3'a,4,4',5,5',6,6'-octahydro-3H,3'H-1,1'-spirobi[pyrrolo[1,2-c]1-oxa-3-aza-2-zincacyclopentane]-1,1-bis(ylium)-2,2'-diuide
- Test material form:
- solid
- Details on test material:
- -Lot: 1310045ZNB
Constituent 1
Test animals
- Species:
- other: QSAR; species not specified
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- other: Developmental toxicity potential
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: Not known precedent reproductive and developmental toxic potential.
- Remarks on result:
- not measured/tested
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- other: Reproductive toxicity potential
- Generation:
- other: Not specified
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Not known reproductive and developmental toxic potential
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Toxicity of the target chemical (Not known precedent reproductive and developmental toxic potential) is predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The current prediction has no applicability domain.
Applicant's summary and conclusion
- Conclusions:
- Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".
- Executive summary:
The potential of the test material to cause reproductive or developmental toxicity was modelled using the OECD QSAR Toolbox. This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.
Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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