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:
2003
Report Date:
2003

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3

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 three rabbits were exposed for 4 hours to 500 mg BIBW2992MA2/BIBW2992BS/patch and animal (semi-occlusive
condition). Animal no. 1 only showed an erythema (grade 1) 1 hour to 48 hours after patch removal.
There were no systemic intolerance reactions.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and
administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present
test conditions,
BIBW2992MA2/BIBW2992BS was non - irritating to skin, hence, no labelling is required (no classification with R-phrases).