Registration Dossier

Toxicological information

Additional toxicological data

Currently viewing:

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication meets generally acceptable scientific principles

Data source

Reference
Reference Type:
publication
Title:
Effect of Several Penetration Enhancers on the Percutaneous Absorption of Indomethacin in Hairless Rats'1
Author:
Sugibayashi K. et al.
Year:
1988
Bibliographic source:
Chem. Pharm. Bull., 36, 1519-1528 (1988)

Materials and methods

Type of study / information:
Study on skin penetration enhancement.
Principles of method if other than guideline:
Study on skin penetration enhancement.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-pyrrolidone
EC Number:
210-483-1
EC Name:
2-pyrrolidone
Cas Number:
616-45-5
Molecular formula:
C4H7NO
IUPAC Name:
pyrrolidin-2-one
Details on test material:
reagent grade

Results and discussion

Any other information on results incl. tables

No data from 2 -Pyrrolidone itself.

Applicant's summary and conclusion

Executive summary:

In order to measure the effect of several penetration enhancers on the percutaneous absorption of drugs and to classify the enhancers into several categories in terms of the mode and mechanism of action, in vitro permeation experiments with a model drug, indomethacin, from aqueous, ethanolic and binary solvent systems were carried out by using excised hairless rat abdominal skin and a 2-chamber diffusion cell at 37 °C.

No data from 2 -pyrrolidone itself.