Registration Dossier
Registration Dossier
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EC number: 642-214-2 | CAS number: 924663-38-7
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- 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:
- 2 012
- Bibliographic source:
- Martindale
- Reference Type:
- secondary source
- Title:
- No information
- Year:
- 2 012
- Bibliographic source:
- Drugdex System
Materials and methods
- Study type:
- other: collateral effects due to the substance administration with therapeutic use
- Endpoint addressed:
- other: specific target organ toxicity after repeated exposure
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 601-501-2
- EC Number:
- 601-501-2
- Cas Number:
- 117976-89-3
- IUPAC Name:
- 601-501-2
- Reference substance name:
- Rabeprazole
- IUPAC Name:
- Rabeprazole
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Results and discussion
- Results:
- Hypergastrinemia is shown due to significant elevations in serum gastrin have been reported. Moreover, other adverse effects are reported by epidemiological data such as effects on the endocrine system and neuropsychiatric symptoms. Finally, it is probably porphyrinogenic.
Applicant's summary and conclusion
- Conclusions:
- Epidemiological data report effects on gastrointestinal tract and other multiple effects system. For these reasons, according to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should be classified for specific target organ toxicity after repeated exposure.
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.
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