Registration Dossier
Registration Dossier
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EC number: 617-500-5 | CAS number: 83905-01-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- PRECLINICAL TOXICOLOGY STUDIES WITH AZITHROMYCIN GENETIC TOXICOLOGY EVALUATION
- Author:
- AMACHER,DE, ELLIS,JH,JR, JOYCE,AJ, MUEHLBAUER,PA, TURNER,GN, WAHRENBURG,MG, HOLDEN,HE AND RAY,VA
- Year:
- 1 993
- Bibliographic source:
- MUTAT. RES. 300(2):79-90, 1993
Materials and methods
- Principles of method if other than guideline:
- Method not published
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2R,3R,4R,5R,8R,10R,11R,13S,14R)-11-[(2S,3R,4S,6R)-4-dimethylamino-3-hydroxy-6-methyl-oxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2S,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyl-oxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one
- EC Number:
- 617-500-5
- Cas Number:
- 83905-01-5
- Molecular formula:
- C38 H72 N2 O12
- IUPAC Name:
- 2R,3R,4R,5R,8R,10R,11R,13S,14R)-11-[(2S,3R,4S,6R)-4-dimethylamino-3-hydroxy-6-methyl-oxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2S,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyl-oxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat, liver, S9
- Test concentrations with justification for top dose:
- Dose: 0.002-1 UG/PLATE
- Vehicle / solvent:
- DMSO
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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