Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 1-cyclopropyl-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate
EC Number:
422-380-0
EC Name:
Ethyl 1-cyclopropyl-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate
Cas Number:
98349-25-8
Molecular formula:
C15H13F2NO3
IUPAC Name:
ethyl 1-cyclopropyl-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: physiological saline solution
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test item/animal)
Topical induction: 50 % (= 250 mg test item/animal)
Challenge: 50 % (= 250 mg/test item/animal)
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: physiological saline solution
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test item/animal)
Topical induction: 50 % (= 250 mg test item/animal)
Challenge: 50 % (= 250 mg/test item/animal)
No. of animals per dose:
Test item group: 10 animals
Control group: 5 animals

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Challenge with a concentration of 50 %
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge with a concentration of 50 %. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge with a concentration of 50 %
Hours after challenge:
72
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge with a concentration of 50 %. . Hours after challenge: 72.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge with a concentration of 50 %
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: Challenge with a concentration of 50 %. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: Challenge with a concentration of 50 %
Hours after challenge:
72
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: Challenge with a concentration of 50 %. . Hours after challenge: 72.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information