Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vivo

Description of key information
The micronucleus test on mouse and unscheduled DNA syntesis on rat do not show any mutagen toxicity.
Link to relevant study records
Reference
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.
Reference:
Composition 0
Composition 0
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 information:
Composition 1
Species:
other: mouse and rat hepatocyte
Strain:
not specified
Sex:
not specified
Route of administration:
other: no data
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

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

Conclusions:
Interpretation of results (migrated information): negative
The micronucleus and unscheduled DNA synthesis tests do not show any mutagen toxicity.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

The micronucleus test on mouse and unscheduled DNA syntesis on rat do not show any mutagen toxicity. Therefore, according to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for mutagenicity.


Justification for selection of genetic toxicity endpoint
The in vivo studies are weighed more than in vitro ones.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for mutagenicity.