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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Reference substance name:
601-501-2
EC Number:
601-501-2
Cas Number:
117976-89-3
IUPAC Name:
601-501-2
Constituent 2
Reference substance name:
Rabeprazole
IUPAC Name:
Rabeprazole
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strainopen allclose all
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Details on mammalian cell type (if applicable):
CHO/HGPRT
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium, other: not specified
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
mouse lymphoma L5178Y cells
Additional strain / cell type 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:
S. typhimurium, 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.