Registration Dossier
Registration Dossier
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EC number: 616-390-6 | CAS number: 76811-98-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro
- Remarks:
- Type of genotoxicity: other: gene mutation and chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A reliable secondary source, summarising Fexofenadine pharmaco-toxicological properties, was used. However the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used. The used secondary source has been updated on 2012; therefore it covers the most updated literature on the substance.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- No information
- Year:
- 2 012
- Bibliographic source:
- FDA label
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The method is not specified.
- GLP compliance:
- not specified
- Type of assay:
- other: Bacterial Reverse Mutation, CHO/HGPRT Forward Mutation, and Rat Lymphocyte Chromosomal Aberration assays
Test material
- Reference substance name:
- 153439-40-8
- EC Number:
- 604-906-2
- Cas Number:
- 153439-40-8
- IUPAC Name:
- 153439-40-8
- Reference substance name:
- Fexofenadine hydrochloride
- IUPAC Name:
- Fexofenadine hydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: Bacterial, CHO/HGPRT and Lymphocyte
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
Results and discussion
Test results
- Species / strain:
- other: Bacterial, CHO/HGPRT and Lymphocyte
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for mutagenicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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