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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
8-Bromo-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione
EC Number:
922-028-0
Cas Number:
853029-57-9
Molecular formula:
C20 H17 Br N6 O2
IUPAC Name:
8-Bromo-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
0,5 g
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h, 72h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1,24,48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
other: "not classified" according CLP
Conclusions:
Under the conditions of the present study, CD 616 BS was well tolerated subsequent to topical application on rabbit skin. There were no macroscopic signs of irritation or corrosion. In addition, there were no signs of systemic side effects or of skin alterations beyond the area of exposure. Thus, according to the Globally Harmonized Hazard Classification and Labeling Scheme (GHS), CD 616 BS is not classified.