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Administrative data

Description of key information

Valsartan showed very low acute toxic potential when administered to rats and marmosets. There were no mortalities or other clinical signs of toxicity in rats at dose levels between 100 and 2,000 mg/kg and in marmosets at 600 and 1,000 mg/kg. The only adverse reaction was vomiting in marmosets at 1,000 mg/kg which may have been related to the volume of the dose (20 mL/kg) or palatability of the test article.

Given the wealth of clinical data which have accumulated over the many years of use in man, data on single dose (acute) toxicity in animals are not considered of real relevance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Sprague Dawley Tif:RAlf
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 0.5% carboxymethylcellulose and 0.5% Tween 80 in purified water
Doses:
1000 and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Valsartan showed very low acute toxic potential when administered to rats and marmosets. There were no mortalities or other clinical signs of toxicity in rats at dose levels between 100 and 2,000 mg/kg and in marmosets at 600 and 1,000 mg/kg. The only adverse reaction was vomiting in marmosets at 1,000 mg/kg which may have been related to the volume of the dose (20 mL/kg) or palatability of the test article.
Given the wealth of clinical data which have accumulated over the many years of use in man, data on single dose (acute) toxicity in animals are not considered of real relevance for the current CDS update.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Single doses (1000 and 2000 mg/kg) of valsartan given to rats by the oral route were practically nontoxic. Single doses of valsartan given to marmosets by the oral route were practically nontoxic. The only reaction was vomiting which may have been related to the volume of the dose or palatability of the test article.