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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
Year:
2002
Report date:
2002

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
N4-(3-chloro-4-fluorophenyl)-7-[(3S)-oxolan-3-yloxy]quinazoline-4,6-diamine
Molecular formula:
C18 H16 Cl F N4 O2
IUPAC Name:
N4-(3-chloro-4-fluorophenyl)-7-[(3S)-oxolan-3-yloxy]quinazoline-4,6-diamine

Test animals

Species:
rabbit
Strain:
Himalayan

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
60min; 24,48 and 72 hours
Number of animals:
3 male

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60min, 24h, 48h and 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60min, 24h, 48h and 72h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the present test conditions none of three rabbits exposed for 4 hours to 500 mg CDBA0578BS/patch and animal (semi-occlusive
conditionl showed any substance-related lesions.
There were no systemic intolerance reactions.

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