Registration Dossier
Registration Dossier
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EC number: 604-776-7 | CAS number: 151213-15-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- July-August 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 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 (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 7-[(4aS,7aS)-1,2,4a,5,7,7a-hexahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6,8-difluoro-4-oxo-3H-quinoline-3-carboxylic acid
- EC Number:
- 604-776-7
- Cas Number:
- 151213-15-9
- Molecular formula:
- C20 H21 F2 N3 O3
- IUPAC Name:
- 7-[(4aS,7aS)-1,2,4a,5,7,7a-hexahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6,8-difluoro-4-oxo-3H-quinoline-3-carboxylic acid
- Details on test material:
- Bay Z 7906, white to yellow powder, batch 501779, purity 99.8%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- Intradermal induction: 2.5 % (= 10 mg test substance/animal)
Topical induction: 6% (= 30 mg test substance/animal)
Challenge: 3% (= 15 mg test substance/animal)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- Intradermal induction: 2.5 % (= 10 mg test substance/animal)
Topical induction: 6% (= 30 mg test substance/animal)
Challenge: 3% (= 15 mg test substance/animal)
- No. of animals per dose:
- control group: 5
test substance group: 10
dose range-finding group: 2
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Challenge 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Challenge 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Challenge 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Any other information on results incl. tables
Appearance and behaviour of the test substance group were not different from the control groups. No mortalities occurred. The body weight development of the treatment group animals corresponded to that of the control group.
Applicant's summary and conclusion
- Executive summary:
To determine the skin-sensitizing properties of Bay Z 7906 the guinea pig maximization test was performed on female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:
intradermal induction: 2.5%
topical induction: 6%
challenge: 3%
Under the condition of the maximization test and with respect to the evaluation criteria Bay Z 7906 exhibited no skin-sensitization potential.
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