Registration Dossier
Registration Dossier
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EC number: 200-064-1 | CAS number: 50-78-2
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Clinical study well performed.
Data source
Reference
- Reference Type:
- publication
- Title:
- Cyclooxygenase-1 and Cyclooxygenase-2 selectivity of widely used nonsteroidal anti-inflammatory drugs.
- Author:
- Cryer B, Feldman M
- Year:
- 1 998
- Bibliographic source:
- Am. J. Med., 104, 413-421.
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- O-acetylsalicylic acid
- EC Number:
- 200-064-1
- EC Name:
- O-acetylsalicylic acid
- Cas Number:
- 50-78-2
- Molecular formula:
- C9H8O4
- IUPAC Name:
- 2-acetoxybenzoic acid
- Details on test material:
- salicylic acid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- other: Study approved by the Human Studies Subcommittee of the Dallas Department of Veterans Affairs Medical Center.
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Acetyl salicylic acid has poor COX-1 and COX-2 inhibitory potencies, and salicylic acid a very low activities. Inhibitory effects of NSAIDs on gastric
prostaglandin E2 synthesis correlated with COX-1 inhibitory potency in blood (P<0.001) and with COX-1 selectivity (P<0.01), but not with COX-2 inhibitory potency. Even COX-2 "selective" NSAIDs still had sufficient COX-1 activity to cause potent inhibitory effects on gastric prostaglandin E2 synthesis at concentrations achieved in vivo. No currently marketed NSAID, even those that are COX-2 selective, spare gastric COX activity at therapeutic
concentrations. Thus, all NSAIDs should be used cautiously until safer agents are developed.
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.
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