ASTM F719-81(2007)e1
(Practice)Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
SIGNIFICANCE AND USE
Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and inexpensive method which, through use over the years, has become a generally accepted method.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a biomaterial may be assessed through contact with abraded and intact skin of rabbits.
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F719 − 81(Reapproved 2007)
Standard Practice for
Testing Biomaterials in Rabbits for Primary Skin Irritation
ThisstandardisissuedunderthefixeddesignationF719;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—Formatting and grammar were corrected editorially throughout in April 2007.
1. Scope 4. Significance and Use
4.1 Materials that are to be in contact with the skin should
1.1 This practice covers a procedure by which the irritancy
not cause irritation to the skin. Since it is probably the
of a biomaterial may be assessed through contact with abraded
substancesleachedfromamaterialthatcausetheirritation,this
and intact skin of rabbits.
practice provides for direct material-skin contact testing or for
1.2 The results of this practice depend upon the effective-
skin exposure to the liquid extract of the test material. The
ness with which contact between the skin and the test material
rationale for this rabbit test is that it is a comparatively quick
is established and maintained. Because of the operator tech-
and inexpensive method which, through use over the years, has
nique included in performing this test, it is important that the
become a generally accepted method.
test be performed by personnel with appropriate training.
1.3 This standard does not purport to address all of the
5. Materials and Manufacture
safety concerns, if any, associated with its use. It is the
5.1 Young New Zealand Albino Rabbits,
responsibility of the user of this standard to establish appro-
5.2 Gauze Flats, 2.5 by 2.5-cm,
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
5.3 Polyethylene Sleeves, extra clear, and
5.4 Adhesive Tape, ⁄2-in.
2. Referenced Documents
2.1 ASTM Standards: 6. Test Specimen
F619 Practice for Extraction of Medical Plastics
6.1 The test specimen may be one of three forms:
6.1.1 Test 0.5 mL of liquids or saline extract liquids ob-
3. Summary of Practice
tained in accordance with Practice F619.
6.1.2 Test 0.5 g of solids or semisolids.
3.1 Exposure of skin to the test material is accomplished by
6.1.3 Test films 2.5 by 2.5 cm.
means of a patch test technique employing two intact and two
abraded sites on the back of each of six albino rabbits.The skin
NOTE 1—A vehicle control for liquids is required because of the
is clipped free of hair one day prior to testing. The test
potential for false positives due to skin temperature changes when
substance is applied using 0.5 mL for liquids, 0.5 g for solids handlingrabbits.Positivecontrolsmaybeusedtovalidatethetestmethod.
The use of 5 % procaine HCl as a positive control is suggested.
or semisolids, and a 2.5 by 2.5-cm square patch for films.After
application,eachtestsiteiscoveredwitha2.5by2.5-cmgauze
6.2 The pH of the solutions should be measured and
flat,andtheentiretrunkisoccludedwithapolyethylenesleeve.
reported, if appropriate.
After 24 h, the sleeve, flat, and test material are removed, and
test sites are evaluated for erythema and edema.
7. Procedure
7.1 Preparation of Test Animals:
7.1.1 Twenty-four hours before the test, clip the hair from
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
the backs of the animals so as to expose two test areas on each
Surgical Materials and Devices and is the direct responsibility of Subcommittee
side of the spine, which are 10 cm apart.
F04.16 on Biocompatibility Test Methods.
7.1.2 To obtain more effective contact between the skin and
Current edition approved Feb. 1, 2007. Published February 2007. Originally
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the test substance, it may be necessary to use a non-irritating
approved in 1981. Last previous edition approved in 2002 as F719 – 81 (2002) .
DOI: 10.1520/F0719-81R07E01.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on H. H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs, and
the ASTM website. Cosmetics, 1965, p. 46.
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F719 − 81 (2007)
TABLE 1 Scoring Criteria for Test Reactions
depilatory agent. This test method may be used to ensure that
the depilatory agent is non-irritating. Reaction Description Score
7.1.3 Testsitesmayb
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