Registration Dossier
Registration Dossier
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EC number: 610-513-7 | CAS number: 502421-44-5
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Read-across
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: guidance document on the grouping of chemicals (Joint meeting of the chemicals committee and the working party on chemical, pesticides and biotechnology, ENV/JM/MONO(2007)28)
- Principles of method if other than guideline:
- The endpoint information of the Valacyclovir, selected as source chemical or analog, was used to predict the same endpoints for the target chemical, i.e. L-Valine, N-[(1,1-dimethylethoxy)carbonyl]-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, which was considered to be similar to Valacyclovir on the basis of structural similarity.
- GLP compliance:
- no
Test material
- Reference substance name:
- 124832-26-4
- EC Number:
- 603-015-6
- Cas Number:
- 124832-26-4
- IUPAC Name:
- 124832-26-4
- Reference substance name:
- Valacyclovir
- IUPAC Name:
- Valacyclovir
- Details on test material:
- - Name of test material (as cited in study report): Valacyclovir
- Molecular formula (if other than submission substance): C13H20N6O4
Constituent 1
Constituent 2
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Result from read-across: not reproductive toxic.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the two structures are similar enough with respect to the physicochemical properties relevant to treproductive toxicity to support the read-across.
Therefore the experimental test result of the source chemical can be read-across to L-Valine, N-[(1,1-dimethylethoxy)carbonyl]-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, concluding that L-Valine, N-[(1,1-dimethylethoxy)carbonyl]-, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester is NOT REPRODUCTIVE TOXIC .
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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