Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(S,S)-trans-4-(acetylamino)-5,6-dihydro-6-methyl-7,7-dioxo-4H-thieno[2,3-b]thiopyran-2-sulfonamide
EC Number:
415-030-3
EC Name:
(S,S)-trans-4-(acetylamino)-5,6-dihydro-6-methyl-7,7-dioxo-4H-thieno[2,3-b]thiopyran-2-sulfonamide
Cas Number:
120298-38-6
Molecular formula:
C10 H14 N2 O5 S3
IUPAC Name:
N-{2-methyl-1,1-dioxo-6-sulfamoyl-2H,3H,4H-1λ⁶-thieno[2,3-b]thiopyran-4-yl}acetamide

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: L-686,771 administered in solid form under gauze pag moistened with water.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: overall 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
No sign of toxicity or ill health in any rabbit.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information