Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48, 72 h. 7, 10 and 14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), Belambre is considered to be "R38-irritating to skin"