ASTM F719-81(2007)
(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.
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
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.
1. Scope practice provides for direct material-skin contact testing or for
skin exposure to the liquid extract of the test material. The
1.1 This practice covers a procedure by which the irritancy
rationale for this rabbit test is that it is a comparatively quick
of a biomaterial may be assessed through contact with abraded
and inexpensive method which, through use over the years, has
and intact skin of rabbits.
become a generally accepted method.
1.2 The results of this practice depend upon the effective-
ness with which contact between skin and the test material is
5. Materials and Manufacture
established and maintained. Because of the operator technique
5.1 Young New Zealand Albino Rabbits,
included in performing this test, it is important that the test be
5.2 Gauze Flats, 2.5 by 2.5-cm,
performed by personnel with appropriate training.
5.3 Polyethylene Sleeves, extra clear, and
1.3 This standard does not purport to address all of the
5.4 Adhesive Tape, ⁄2-in.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
6. Test Specimen
priate safety and health practices and determine the applica-
6.1 The test specimen may be one of three forms:
bility of regulatory limitations prior to use.
6.1.1 Test 0.5 mL of liquids or saline extract liquids ob-
tained in accordance with Practice F 619.
2. Referenced Documents
6.1.2 Test 0.5 g of solids or semisolids.
2.1 ASTM Standards:
6.1.3 Test films 2.5 by 2.5 cm.
F 619 Practice for Extraction of Medical Plastics
NOTE 1—A vehicle control for liquids is required because of the
3. Summary of Practice
potential for false positive due to skin temperature changes when handling
rabbits. Positive controls may be used to validate the test method. The use
3.1 Exposure of skin to the test material is accomplished by
of 5 % procaine HCl as a positive control is suggested.
means of a patch test technique employing two intact and two
abradedsitesonthebackofeachofsixalbinorabbits.Theskin
6.2 The pH of the solutions should be measured and
is clipped free of hair one day prior to testing. The test
reported, if appropriate.
substance is applied using 0.5 mL for liquids, 0.5 g for solids
7. Procedure
or semisolids, and a 2.5 by 2.5-cm square patch for films.After
application,eachtestsiteiscoveredwitha2.5by2.5-cmgauze
7.1 Preparation of Test Animals:
flat,andtheentiretrunkisoccludedwithapolyethylenesleeve. 7.1.1 Twenty-four hours before the test, clip the hair from
After 24 h, the sleeve, flat, and test material are removed, and
the backs of the animals so as to expose two test areas on each
test sites are evaluated for erythema and edema. side of the spine, which are 10 cm apart.
7.1.2 To obtain more effective contact between the skin and
4. Significance and Use
the test substance, it may be necessary to use a nonirritating
4.1 Materials that are to be in contact with the skin should
depilatory agent. This test method may be used to ensure that
not cause irritation to the skin. Since it is probably the
the depilatory agent is nonirritating.
substancesleachedfromamaterialthatcausetheirritation,this
7.1.3 Testsitesmaybedesignatedastwooneachsideofthe
spine. Alternatively, the area may be divided into quadrants
with test and control substances applied to each quadrant.
7.2 Test Procedure:
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
7.2.1 Wipe the exposed area of the back with alcohol.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods. 7.2.2 Using a sterile blade, abrade two of the four sites by
Current edition approved Feb. 1, 2007. Published February 2007. Originally
moving the blade at right angles to the cutting surface in a
e1
approved in 1981. Last previous edition approved in 2002 as F 719 – 81 (2002) .
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, Ap
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