Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 642-214-2 | CAS number: 924663-38-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Description of key information
Link to relevant study records
- 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.
- 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
- 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 validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Sex:
- not specified
- Genotoxicity:
- negative
- Remarks:
- unscheduled DNA synthesis
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Interpretation of results (migrated information): negative
The micronucleus and unscheduled DNA synthesis tests do not show any mutagen toxicity.
Reference
Rabeprazole was negative in the in vivo mouse micronucleus test, and the in vivo and ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) tests.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
