Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 610-513-7 | CAS number: 502421-44-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 21, 2011
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 869
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
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 20000 mg/kg
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: data on Valacyclovir
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- It is concluded that the two structures are similar enough with respect to the physicochemical properties relevant to the acute toxicity by oral route 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 TOXIC by oral route on rat.
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