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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyl-4-chloro-4,5-dihydro-5-hydroxymethyl-1-[2'-(2-triphenylmethyl-1,2,3,4-2H-tetrazol-5-yl)-1,1'-biphenyl-4-methyl]-1H-imidazole
EC Number:
412-420-5
EC Name:
2-butyl-4-chloro-4,5-dihydro-5-hydroxymethyl-1-[2'-(2-triphenylmethyl-1,2,3,4-2H-tetrazol-5-yl)-1,1'-biphenyl-4-methyl]-1H-imidazole
Cas Number:
133909-99-6
Molecular formula:
C41H37ClN6O
IUPAC Name:
[2-butyl-4-chloro-1-({2'-[2-(triphenylmethyl)-2H-1,2,3,4-tetrazol-5-yl]-[1,1'-biphenyl]-4-yl}methyl)-1H-imidazol-5-yl]methanol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: 1% w/v aqueous methylcellulose
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males
5 females
Control animals:
no

Results and discussion

Any other information on results incl. tables

Clinical signs were limited to pilo-erection. Recovery was complete by Day 3. No abnormalities were recorded at the macroscopic examination on Day 15

Applicant's summary and conclusion