Registration Dossier
Registration Dossier
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EC number: 604-776-7 | CAS number: 151213-15-9
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- August 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported non-GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Type of study / information:
- Study of photoreactive potential in mice
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 406
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OPPTS 870.2600
- GLP compliance:
- no
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, batch 501781
Constituent 1
Results and discussion
Any other information on results incl. tables
The study indicate that LLNA does not show a significant specific immunostimulating (photosensitizing) potential of Bay Z 7906 after dermal application.
This applies to NMRI mice, for weight and cell count and ear swelling indices evaluated after epicutaneous application of Bay Z 7906 onto both ears of the animals. FACScan analyses of lymph nodes from the treated mice further support this conclusion.
In addition, a photoirritating potential was also not determined after dermal application up to and including 10% Bay Z 7906.
Applicant's summary and conclusion
- Executive summary:
A LLNA/IMDS assay was conducted in female NMRI mice to examine if there is any specific (photosensitizing) or non-specific (photoirritating) stimulating potential of Bay Z 7906. The results show that Bay Z 7906 has no photoreactive potential in mice after dermal application and UV-A irradiation. No significant difference compared to vehicle treated animals regarding the weight or cell counts of the draining lymph nodes as well as ear swelling was reached in any case.
Thus, no hint for a substance specific or non-specific activation of the cells of the immune system via dermal application was found by the method used.
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