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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: 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
Principles of method if other than guideline:
Not specified.
GLP compliance:
not specified
Test type:
other: available information refers to the overall assessment of results from several type of studies not described in detail
Test material information:
Composition 1
Species:
other: rat and mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
rat 1024 mg/kg
mouse 786 mg/kg
No. of animals per sex per dose:
no data
Control animals:
not specified
Sex:
not specified
Dose descriptor:
other: rat lethality
Effect level:
ca. 1 024 mg/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
other: mice lethality
Effect level:
ca. 786 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for acute oral toxicity because the data are scarce.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for acute oral toxicity because the data are scarce.


Justification for selection of acute toxicity – oral endpoint
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for acute oral toxicity because the data are scarce.

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 acute oral toxicity.