Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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.3 (Acute Toxicity (Dermal))
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

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24 hours
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

Local : no irrittation or other dermal changes observed

Systemic : there were no signs of systemic reaction to treatment

Effect on organs ( related to dose level) : no macroscopic abnormalities were observed for animals killed on Day 15.

Slightly reduced bodyweight gains were recorded for 5 males and 2 females on Day 8 and for 4 males do Day 15. The remaining male animal and 5 females achieved anticipated bodyweght gains by Day 15.

Applicant's summary and conclusion