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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
Reference substance name:
601-501-2
EC Number:
601-501-2
Cas Number:
117976-89-3
IUPAC Name:
601-501-2
Constituent 2
Reference substance name:
Rabeprazole
IUPAC Name:
Rabeprazole
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.