Registration Dossier

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:
2010
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48 and 72h
Number of animals:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72
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 conditions of the present study, a single dermal administration of BI 10773 TMSLACTON,
a starting material for BI 10773 XX, was well tolerated in rabbits. Thus, according
to the Globally Harmonized Hazard Classification and Labeling Scheme (GHS), the test item
was not classified.