Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summary data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Kodak footpad method
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
0.05 mL of a 1.0% solution in Freund's Complete Adjuvant

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Challenge
Route:
intradermal
No. of animals per dose:
10
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Group:
other: Freund's only
Dose level:
0.1 % in acetone/dioxane/guinea pig fat (7:2:1)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
all animals appeared normal
Remarks on result:
other: Reading: rechallenge. Group:
Reading:
rechallenge
Group:
other: 1% cpd. in Freund's
Dose level:
0.1% in acetone/dioxane/guinea pig fat (7:2:1)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
all animals appeared normal
Remarks on result:
other: Reading: rechallenge. Group:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test compound has a low potential for causing human sensitizaiton. No reaction was noted in either the induced or control groups when challenged
Executive summary:

The test compound has a low potential for causing human sensitizaiton. No reaction was noted in either the induced or control groups when challenged