Registration Dossier

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:
23 June - 18 August 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted in 1992 in GLP compliance and was well performed and described. However, no clear reference is given within the study description. BIBR 277 CL is the hydrochloride of BIBR 277 SE (Telmisartan, free acid).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was conducted in 1992 in GLP compliance and was well performed and described. However, no clear reference is given within the study description.
GLP compliance:
yes
Test type:
other: no data
Limit test:
yes

Test material

Constituent 1
Reference substance name:
BIBR 277 SE
IUPAC Name:
BIBR 277 SE
Test material form:
other: peg milled solid
Details on test material:
- Name of test material (as cited in study report): BIBR 277 SE
- Physical state: solid /milled
- Lot/batch No.: 8230151
- Expiration date of the lot/batch: June 30, 1993
- Stability under test conditions: yes

Test animals

Species:
rat
Strain:
other: Chbb: THOM (SPF), albino rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: testing lab
- Age at study initiation: 43 days
- Weight at study initiation: 137 - 166g
- Fasting period before study: fasting was performed for one day prior to study initiation
- Housing: collective housing in Macrolon cages, type III.
- Diet (e.g. ad libitum): Pellets ad libitum during quarantine and observation period
- Water (e.g. ad libitum): municipal drinking water was supplied ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 45% - 75%
- Air changes (per hr): maximum 16 /hour
- Photoperiod (hrs dark / hrs light): 9/15 hours (7am - 4pm)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Hydroxyethylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/ml
- Amount of vehicle (if gavage): determined on the day of administration, based on the individual body weight.

Doses:
single dose per animal, c = 2000 mg/kg bodyweight.
No. of animals per sex per dose:
each 3 male and female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no animals died at any time of the study
Clinical signs:
no clinical signs were observed at any time of the study
Gross pathology:
no gross lesions were seen during gross pathology

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The ALD50 of BIBR 277 SE following oral administration in rats is higher than 2000 mg/kg bodyweight.