Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: other:
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 Rabeprazole 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

Referenceopen allclose all

Reference Type:
secondary source
Title:
No information
Year:
2012
Bibliographic source:
HSDB - Hazardous Substances Data Bank
Reference Type:
secondary source
Title:
No information
Year:
2012
Bibliographic source:
Physicians' desk reference - 66th ed p.893

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Not specified.
GLP compliance:
not specified
Type of assay:
other: bacterial reverse mutation assay, in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strainopen allclose all
Species / strain:
Chinese hamster Ovary (CHO)
Details on mammalian cell lines (if applicable):
CHO/HGPRT
Additional strain characteristics:
not specified
Metabolic activation:
not specified
Species / strain:
other: not specified
Additional strain characteristics:
not specified
Metabolic activation:
not specified
Species / strain:
mouse lymphoma L5178Y cells
Additional strain characteristics:
not specified
Metabolic activation:
not specified

Results and discussion

Test resultsopen allclose all
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
not specified
Genotoxicity:
positive
Species / strain:
other: not specified
Metabolic activation:
not specified
Genotoxicity:
positive
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
not specified
Genotoxicity:
positive

Any other information on results incl. tables

Rabeprazole was positive in the Ames test, the Chinese hamster ovary cell (CHO/HGPRT) forward gene mutation test and the mouse lymphoma cell (L5178Y/TK+/-) forward gene mutation test.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

The in vitro studies show a mutagenicity in all tests aforementioned.