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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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