Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin 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
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
465-070-0
EC Name:
-
Cas Number:
518048-03-8
Molecular formula:
C16H19FN403
IUPAC Name:
2-(1-amino-1-methylethyl)-N-(4-fluorobenzyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
Details on test material:
L-000900405-000M004

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
0.5g moistened with 0.5 ml of distilled water to form a pasty consistency.
Duration of treatment / exposure:
skin contact = 4 hours
Observation period:
Observation periods : 60 minutes - 24 hours - 48 hours - 72 hours
Number of animals:
2 males and 1 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 60 minutes
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
other: 60 minutes
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
other: 24 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
other: 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
other: 60 minutes
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
other: 24 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 60 minutes
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
other: 60 minutes
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
other: 72 hours
Score:
0

Any other information on results incl. tables

edema score  animal#3 female  60 minutes 

 0

     24 hours  0
     48 hours

 0

     72 hours  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU