Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute 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:
2006
Bibliographic source:
European Medicines Agency

Materials and methods

GLP compliance:
yes
Test type:
other: Single dose toxicity

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Doses:
up yo 1500 mg/kg
Control animals:
not specified

Results and discussion

Any other information on results incl. tables

There were no deaths or clinical abnormalities recorded in rats.

Applicant's summary and conclusion