Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable with restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: See comments
Principles of method if other than guideline:
The study uses a method with a longer exposure time than that required in Annex V guidelines. Although it was not conducted to GLP, on the grounds of animal welfare and considering the clearly negative results, the UK c.a. have accepted this study. The method used was Guidelines of the Consumer Product Safety Commission, Title 16, Chapter II Part 1500.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
other: 0.9% Sodium chloride solution
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hrs and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24hrs and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Other effects:
None

Any other information on results incl. tables

The study uses a method with a longer exposure time than
that required in Annex V guidelines. Although it was not
conducted to GLP, on the grounds of animal welfare and
considering the clearly negative results, the UK c.a. have
accepted this study. The method used was Guidelines of the
Consumer Product Safety Commission, Title 16, Chapter II
Part 1500.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU