ASTM F719-81(1996)e1
(Practice)Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
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 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.
1.3 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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e1
Designation: F 719 – 81 (Reapproved 1996)
Standard Practice for
Testing Biomaterials in Rabbits for Primary Skin Irritation
This standard is issued under the fixed designation F 719; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Keywords were added editorially in December 1996.
1. Scope rationale for this rabbit test is that it is a comparatively quick
and inexpensive method which, through use over the years, has
1.1 This practice covers a procedure by which the irritancy
become a generally accepted method.
of a biomaterial may be assessed through contact with abraded
and intact skin of rabbits.
5. Materials and Manufacture
1.2 The results of this practice depend upon the effective-
5.1 Young New Zealand Albino Rabbits,
ness with which contact between skin and the test material is
5.2 Gauze Flats, 2.5 by 2.5-cm ,
established and maintained. Because of the operator technique
5.3 Polyethylene Sleeves, extra clear, and
included in performing this test, it is important that the test be
5.4 Adhesive Tape, ⁄2-in.
performed by personnel with appropriate training.
1.3 This standard does not purport to address all of the
6. Test Specimen
safety concerns, if any, associated with its use. It is the
6.1 The test specimen may be one of three forms:
responsibility of the user of this standard to establish appro-
6.1.1 Test 0.5 mL of liquids or saline extract liquids ob-
priate safety and health practices and determine the applica-
tained in accordance with Practice F 619.
bility of regulatory limitations prior to use.
6.1.2 Test 0.5 mL of solids or semisolids.
6.1.3 Test films 2.5 by 2.5 cm.
2. Referenced Documents
2.1 ASTM Standards:
NOTE 1—A vehicle control for liquids is required because of the
F 619 Practice for Extraction of Medical Plastics potential for false positive due to skin temperature changes when handling
rabbits. Positive controls may be used to validate the test method. The use
3. Summary of Practice
of 5 % procaine HCl as a positive control is suggested.
3.1 Exposure of skin to the test material is accomplished by
6.2 The pH of the solutions should be measured and
means of a patch test technique employing two intact and two
reported.
abraded sites on the back of each of six albino rabbits. The skin
7. Procedure
is clipped free of hair one day prior to testing. The test
substance is applied using 0.5 mL for liquids, 0.5 g for solids 7.1 Preparation of Test Animals:
or semisolids, and a 2.5 by 2.5-cm square patch for films. After
7.1.1 Twenty-four hours before the test, clip the hair from
application, each test site is covered with a 2.5 by 2.5-cm gauze the backs of the animals so as to expose two test areas on each
flat, and the entire trunk is occluded with a polyethylene sleeve. side of the spine, which are 10 cm apart.
After 24 h, the sleeve, flat, and test material are removed, and
7.1.2 To obtain more effective contact between the skin and
test sites are evaluated for erythema and edema. the test substance it may be necessary to use a nonirritating
depilatory agent. This test method may be used to ensure that
4. Significance and Use
the depilatory agent is nonirritating.
4.1 Materials that are to be in contact with the skin should
7.1.3 Test sites may be designated as two on each side of the
not cause irritation to the skin. Since it is probably the
spine. Alternatively, the area may be divided into quadrants
substances leached from a material that cause the irritation, this
with test and control substances applied to each quadrant.
practice provides for direct material-skin contact testing or for
7.2 Test Procedure:
skin exposure to the liquid extract of the test material. The
7.2.1 Wipe the exposed area of the back with alcohol.
7.2.2 Using a sterile blade, abrade two of the four sites by
moving the blade at right angles to the cutting surface in a
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and
scraping motion to create a denuded area of skin. Alternatively,
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved April 24, 1981. Published July 1981. Originally
published as F 791 – 81. H. H. Draize, Appraisal of the Safety of Chemicals in
...
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