Registration Dossier
Registration Dossier
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EC number: 604-571-2 | CAS number: 147127-20-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: EPAR Scientific discussion
- Title:
- Viread - EPAR Scientific discussion
- Year:
- 2 006
- Bibliographic source:
- European Medicines Agency
Materials and methods
- GLP compliance:
- yes
Test material
- Reference substance name:
- 202138-50-9
- Cas Number:
- 202138-50-9
- IUPAC Name:
- 202138-50-9
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 42 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
the highest doses were 1000 mg/kg in rats
Basis:
- Control animals:
- not specified
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
In rats, the target organs were the gastro-intestinal tract (intestinal epithelial hypertrophy/slight to moderate intestinal hyperplasia) and kidney (renal tubular epithelial karyomegaly and pigment accumulation at dose of 30 mg/kg/day). It was suggested that gastro-intestinal lesions could be rodent specific occurring at the highest doses as no signs were reported in either monkeys or in dogs. It was agreed however that this finding should be further investigated. Changes in serum chemistry parameters, including dose-related slight to moderate changes in cholesterol, triglycerides, ALT, AST and creatinine were also reported in the 300 mg dose group. All these effects were reversible after treatment discontinuation. The no-observed effect-level (NOEL) determined was less than 30 mg/kg, and therefore no overall safety margins could be established.
Applicant's summary and conclusion
- Conclusions:
- NOEL (rat): < 30 mg/Kg./day
Target organs: bone, kidney.
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