Registration Dossier
Registration Dossier
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EC number: 200-064-1 | CAS number: 50-78-2
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No indication of GLP and study with patches
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of Transdermally Delivered Aspirin on Blood Coagulation Parameters
- Author:
- Shamsher, A.A. et al.
- Year:
- 2 010
- Bibliographic source:
- American Journal of Biomedical Sciences 2(2), 129-141
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 427 (Skin Absorption: In Vivo Method)
- GLP compliance:
- not specified
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
- Test material form:
- other: solvant
Constituent 1
Test animals
- Species:
- human
Administration / exposure
- Vehicle:
- other: lemon oil and turpentine
- Duration of exposure:
- 24 hours
Results and discussion
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- no effects
- Absorption in different matrices:
- no more than 1%
Applicant's summary and conclusion
- Conclusions:
- It is clearly shown on rat or human skin that ASA do not penetrated more than 1 or 2% without a vehicle
- Executive summary:
The feasibility of delivering aspirin transdermally from eudragit and polyvinyl acetate (PVA) matrix-type patches to enhance its antithrombotic efficiency of aspirin was investigated. Transdermal films containing mixture of eudragit RL: eudragit RS and polyvinyl acetate were fabricated. Eudragit RL: eudragit RS (5:1) films containing 30 mg/ transdermal patch aspirin showed maximum release (11.891.1g/cm2) after 24 hrs as compared to PVA films. With regards to appearance eudragit films were also wrinkle free, uniform, flexible and transparent with good adhesion property to skin. The effect of turpentine oil and lemon oil at different concentrations on the in vitro percutaneous absorption of aspirin from eudragit copolymer patches through rat skin was investigated. Two formulation containing 50 mg/transdermal patch ASA with 0.042 ml turpentine oil and 0.042 ml lemon oil showed a significantly higher flux of ASA 4.22 g/cm2/hr and 38.52 g/cm2/hr respectively. The optimized formulations influenced the blood coagulation parameters (bleeding time, prothrombin time, Activated partial prothrombin time) significantly by means of affecting both the extrinsic coagulation system and the intrinsic coagulation system as compared to orally administered and control gel formulations.
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