Registration Dossier
Registration Dossier
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EC number: 616-390-6 | CAS number: 76811-98-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: 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:
- micronucleus assay
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
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: no data
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
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.
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