Registration Dossier

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:
2012
Bibliographic source:
Martindale
Reference Type:
secondary source
Title:
No information
Year:
2012
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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.