Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
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 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: micronucleus test and unscheduled DNA synthesis

Test material

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

Test animals

Species:
other: mouse and rat hepatocyte
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: no data

Results and discussion

Test resultsopen allclose all
Sex:
not specified
Genotoxicity:
negative
Remarks:
micronucleus test
Toxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Sex:
not specified
Genotoxicity:
negative
Remarks:
unscheduled DNA synthesis
Toxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified

Any other information on results incl. tables

Rabeprazole was negative in the in vivo mouse micronucleus test, and the in vivo and ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) tests.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The micronucleus and unscheduled DNA synthesis tests do not show any mutagen toxicity.