Registration Dossier

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:
2004
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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:
water
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h and 72h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
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, BI 1356/CD 713 TD 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), the test item BI 1356/CD 713 TD
is not classified.
Executive summary:

Based on current German law (Chemikaliengesetz [Chemicals Act] 2002), this study was designed to evaluate the dermal tolerance of BI 1356/CD 713 TD subsequent to topical application in rabbits. It was performed according to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and in accordance with the principles of Good Laboratory Practice, as described by the respective OECD Guidelines and current German law (Chemikaliengesetz 2002).

A total of three female New Zealand White rabbits were exposed dermally to a paste of approximately 0.5 g test item mixed with demineralized water. One female was treated at three different sites for 3 min, 1 h, and 4 h, respectively, whereas the remaining two females were exposed for 4 h at a single site only. Skin reactions were recorded 1 h, as well as 24 h, 48 h, and 72 h following the end of exposure and graded. Further investigations included recording of clinical signs and body weight.

Under the conditions of the present study, BI 1356/CD 713 TD 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), the test item BI 1356/CD 713 TD is not classified.