Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
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.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

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 / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
maxi duration : 96 hours
Observation period (in vivo):
24 - 48 - 72 - 96 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 96 hours
Max. score:
1.67
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 96 hours
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 96 hours
Max. score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 72 hours
Max. score:
0.67
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 72 hours
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 72 hours
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Max. score:
0

Any other information on results incl. tables

There were no signs of toxicity or ill health in any rabbit

Applicant's summary and conclusion