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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
increased humidity for 2 day in convential animal rooms, no influence to the results of study
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate
EC Number:
700-258-0
Cas Number:
125971-95-1
Molecular formula:
C40H47FN2O5
IUPAC Name:
tert-butyl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: substance moistened with smallest amounth of water
Controls:
no
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
initial test 3min, 1hour, 4hours
test 4hours
Observation period:
1, 24,48,72hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour, 24hours, 48 hours, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour, 24hours, 48 hours, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour, 24hours, 48 hours, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour, 24hours, 48 hours, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 hour, 24hours, 48 hours, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 hour, 24hours, 48 hours, 72 hours
Score:
0
Max. score:
4

Any other information on results incl. tables

 Time after 4 -hours exposure Rabbit No.1        Rabbit No.2     Rabbit No.3   
 1 hour    Erythema  0   Erythema  0   Erythema  0
 Oedema  0   Oedema  0   Oedema  0
   24 hours   Erythema  0   Erythema  0   Erythema  0
    Oedema  0   Oedema  0   Oedema  0
  48 hours   Erythema  0   Erythema  0   Erythema  0
    Oedema  0   Oedema  0   Oedema  0
  72 hours   Erythema  0   Erythema  0   Erythema  0
    Oedema  0   Oedema  0   Oedema  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results no skin irritation was caused by substance.