of skin exposed to the test substance over the exposure period can also be obtained.
3. REPORTING
3.1. TEST REPORT
The test report must include the requirements stipulated in the protocol, including a justification for the test system used and should comprise the following:
test substance:
— identification data (e.g. CAS number, if available, source, purity (radiochemical purity), known impurities, lot number),
— physical nature, physicochemical properties (e.g. pH, volatility, solubility, stability, molecular weight and log P
ow
).
Test preparation:
— formulation and justification of use,
— details of the test preparation, amount applied, achieved concentration, vehicle, stability and homogeneity.
Test animal:
— species/strain used,
— number, age and sex of animals,
— source of animals, housing conditions, diets, etc.,
— individual animal weights at start of test.
Test conditions:
— details of the administration of the test preparation (site of application, assay methods, occlusion/non-occlusion, volume, extraction, detection),
— details of food and water quality.
Results:
— any signs of toxicity,
— tabulated absorption data (expressed as rate, amount or percentage),
— overall recoveries of the experiment,
— interpretation of the results, comparison with any available data on percutaneous absorption of the test compound.
Discussion of the results.
Conclusions.
4. REFERENCES
(1) Testing Method B.45. Skin Absorption:
In vitro
Method.
(2) OECD (2002). Guidance Document for the Conduct of Skin Absorption Studies. OECD, Paris.
(3) ECETOC, (1993) Percutaneous Absorption. European Centre for Ecotoxicology and Toxicology of Chemicals, Monograph No 20.
(4) Zendzian R.P. (1989) Skin Penetration Method suggested for Environmental Protection Agency Requirements.
J. Am. Coll. Toxicol
. 8(5), p. 829-835.
(5) Kemppainen, B.W., Reifenrath WG (1990) Methods for skin absorption. CRC Press Boca Raton, FL, USA.
(6) EPA, (1992) Dermal Exposure Assessment: Principles and Applications. Exposure Assessment Group, Office of Health and Environmental Assessment.
(7) EPA, (1998) Health Effects Test Guidelines, OPPTS 870-7600, Dermal Penetration. Office of Prevention, Pedsticides and Toxic Substances.
(8) Bronaugh, R.L., Wester, R.C., Bucks, D., Maibach H.I. and Sarason, R., (1990) In vivo percutaneous absorption of fragrance ingredients in reshus monkeys and humans.
Fd. Chem. Toxic.
28, p. 369-373.
(9) Feldman, R.J. and Maibach, H.I., (1970) Absorption of some organic compounds through the skin in man.
J. Invest Dermatol.
54, p. 399-404.
Figure 1
An example of a design of a typical device used to define and protect dermal application site during
in vivo
percutaneous absorption studies
[Bild bitte in Originalquelle ansehen]
B.45. SKIN ABSORPTION:
IN VITRO
METHOD
1. METHOD
This testing method is equivalent to the OECD TG 428 (2004).