Registration Dossier
Registration Dossier
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EC number: 695-943-3 | CAS number: 151006-11-0
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Type of information:
- other: DEREK Nexus software
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: not OECD method
Data source
Reference
- Reference Type:
- other:
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- GLP compliance:
- no
Test material
- Reference substance name:
- Ammonium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphtalen-1-yl]heptanoate
- Cas Number:
- 151006-11-0
- Molecular formula:
- C23 H36 O7 . H3 N
- IUPAC Name:
- Ammonium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphtalen-1-yl]heptanoate
Constituent 1
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Computational toxicology summary was prepared by DEREK Nexus version 2.0.2 software, and the result for reproductive toxicity is negative.
- Executive summary:
Computational toxicology summary was prepared by DEREK Nexus version 2.0.3 software, and the result for reproductive toxicity is negative.
Inspite of this fact the company classifed Pravastatin ammonium as Reproductive toxicity – Category 2 – H361d and Reproductive toxicity – effects on or via lactation – H362
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