Registration Dossier
Registration Dossier
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EC number: 642-214-2 | CAS number: 924663-38-7
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- 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.
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- 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)
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for cancer toxicity.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
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.
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.
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