Registration Dossier
Registration Dossier
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EC number: 239-784-6 | CAS number: 15687-27-1
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Type of study / information:
- pharmacological tolerance
Test material
- Reference substance name:
- Sodium 2-(4-isobutylphenyl)propionate
- EC Number:
- 250-477-6
- EC Name:
- Sodium 2-(4-isobutylphenyl)propionate
- Reference substance name:
- Ethyl 2-(4-isobutylphenyl)propionate
- EC Number:
- 255-291-9
- EC Name:
- Ethyl 2-(4-isobutylphenyl)propionate
- Cas Number:
- 41283-72-1
- Molecular formula:
- C15H22O2
- IUPAC Name:
- ethyl 2-(4-isobutylphenyl)propanoate
- Details on test material:
- two-gram suppositories containing
- 100 mg ethyl ibuprofen in a Witepsol base (Beeston formulation),
- 600 mg ethyl ibuprofen in a Witepsol base (Beeston formulation),
- 600 mg sodium ibuprofen in a Witepsol base (Beeston formulation), or
- 600 mg sodium ibuprofen in an unknown base (Formenti formulation)
No further data.
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Two-gram suppositories containing:
- 100 mg ethyl ibuprofen in a Witepsol base (Beeston formulation),
- 600 mg ethyl ibuprofen in a Witepsol base (Beeston formulation),
- 600 mg sodium ibuprofen in a Witepsol base (Beeston formulation), or
- 600 mg sodium ibuprofen in an unknown base (Formenti formulation)
No further data.
Results and discussion
Any other information on results incl. tables
The drug was well tolerated and drug absorption was slow. Both suppository formulations (Beeston and Formenti) containing 600 mg sodium ibuprofen were non-irritating following single rectal administration to dogs, and gave comparable plasma concentrations of ibuprofen. Sodium ibuprofen suppositories were better absorbed than ethyl ibuprofen suppositories. Therefore, it was concluded that the latter were likely to achieve lower plasma concentrations of ibuprofen in human patients. Further, dogs may be less sensitive than man to rectal irritation by sodium ibuprofen suppositories.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
