Registration Dossier

Diss Factsheets

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:
2012
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

Constituent 1
Reference substance name:
153439-40-8
EC Number:
604-906-2
Cas Number:
153439-40-8
IUPAC Name:
153439-40-8
Constituent 2
Reference substance name:
Fexofenadine hydrochloride
IUPAC Name:
Fexofenadine hydrochloride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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.