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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.
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
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.