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Toxicological information

Carcinogenicity

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Description of key information

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
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.
Reference:
Composition 0
Composition 0
Qualifier:
no guideline available
GLP compliance:
not specified
Test material information:
Composition 1
Species:
mouse
Strain:
CD-1
Sex:
not specified
Route of administration:
oral: unspecified
Duration of treatment / exposure:
88/104 weeks
Remarks:
Doses / Concentrations:
100 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
no data
Relevance of carcinogenic effects / potential:
The test material did not produce any increased tumor occurrence.
Dose descriptor:
NOAEL
Effect level:
ca. 100 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: The test material did not produce any increased tumor occurrence.
Remarks on result:
not determinable
Remarks:
no NOAEL identified. Effect type:other: do not produce any increased tumor (migrated information)

In a 88/104 -week carcinogenicity study in CD-1 mice, rabeprazole at oral doses up to 100 mg/kg/day did not produce any increased tumor occurrence.

Conclusions:
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for cancer toxicity.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
100 mg/kg bw/day
Study duration:
chronic
Species:
mouse

Additional information

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


Justification for selection of carcinogenicity via oral route endpoint:
The test material did not produce any increased tumor occurrence.

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 cancer toxicity.