Registration Dossier

Administrative data

Endpoint:
developmental toxicity
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:
HSDB - Hazardous Substances Data Bank
Reference Type:
secondary source
Title:
No information
Year:
2012
Bibliographic source:
Physicians' desk reference - 66th ed p.891

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Not specified.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
other: rat and rabbit
Strain:
not specified

Administration / exposure

Route of administration:
intravenous
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
50 mg/kg bw on rat
Basis:
no data
Remarks:
Doses / Concentrations:
30 mg/kg bw on rabbit
Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no data

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOAEL
Effect level:
ca. 50 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: teratogenicity
Remarks on result:
not determinable
Remarks:
no NOAEL identified
Dose descriptor:
NOAEL
Effect level:
ca. 30 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: teratogenicity
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

No effects were shown on impaired fertility of rabeprazole.

The read-across approach is applied in order to transfer the rabeprazole information to RABE-750.

Applicant's summary and conclusion

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