ASTM F719-20
(Practice)Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
SIGNIFICANCE AND USE
4.1 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 sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a material 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.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard may involve hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Designation: F719 − 20
Standard Practice for
1
Testing Materials 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.
1. Scope abradedsitesonthebackofeachofthreealbinorabbitspertest
article. The skin is clipped free of hair one day prior to testing.
1.1 This practice covers a procedure by which the irritancy
The test substance is applied using 0.5 mLfor liquids, 0.5 g for
ofamaterialmaybeassessedthroughcontactwithabradedand
solidsorsemisolids,anda2.5by2.5-cmsquarepatchforfilms.
intact skin of rabbits.
After application, each test site is covered with a 2.5 by 2.5-cm
1.2 The results of this practice depend upon the effective-
gauze flat, and the entire trunk is occluded with a polyethylene
ness with which contact between the skin and the test material
sleeve. After 24 h, the sleeve, flat, and test material are
is established and maintained. Because of the operator tech-
removed, and test sites are evaluated for erythema and edema.
nique included in performing this test, it is important that the
test be performed by personnel with appropriate training.
4. Significance and Use
1.3 The values stated in SI units are to be regarded as
4.1 Materials that are to be in contact with the skin should
standard. No other units of measurement are included in this
not cause irritation to the skin. Since it is probably the
standard.
substancesleachedfromamaterialthatcausetheirritation,this
1.4 This standard may involve hazardous materials,
practice provides for direct material-skin contact testing or for
operations, and equipment. This standard does not purport to
skin exposure to the liquid extract of the test material. The
address all of the safety concerns, if any, associated with its
rationale for this rabbit test is that it is a comparatively quick
use. It is the responsibility of the user of this standard to
and sensitive method which, through use over the years, has
establish appropriate safety, health, and environmental prac-
become a generally accepted method. Additionally, the albino
tices and determine the applicability of regulatory limitations
rabbit allows for easy visualization of erythema and edema,
prior to use.
which are the cardinal signs of skin irritation.
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
5. Materials and Manufacture
ization established in the Decision on Principles for the
5.1 Young New Zealand Albino Rabbits, Healthy young
Development of International Standards, Guides and Recom-
adult albino rabbits of either sex, weighing not less than 2 kg,
mendations issued by the World Trade Organization Technical
shall be used. Animal care shall be in accordance with the
Barriers to Trade (TBT) Committee.
3
“Guide for Care and Use of Laboratory Animals”;
2. Referenced Documents
5.2 Gauze Flats, 2.5 by 2.5-cm;
2
2.1 ASTM Standards:
5.3 Polyethylene Sleeves, extra clear;
F619 Practice for Extraction of Medical Plastics
1
5.4 Adhesive Tape, ⁄2-in. width.
3. Summary of Practice
3.1 Exposure of skin to the test material is accomplished by
6. Test Specimen
means of a patch test technique employing two intact and two
6.1 The test specimen may be one of three forms:
6.1.1 Test 0.5 mL of liquids, saline, or vegetable oil extract
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
liquids obtained in accordance with Practice F619.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
6.1.2 Test 0.5 g of solids or semisolids.
Current edition approved April 1, 2020. Published June 2020. Originally
6.1.3 Test films 2.5 by 2.5 cm.
approved in 1981. Last previous edition approved in 2012 as F719 – 81 (2012).
DOI: 10.1520/F0719-20.
2
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
3
Standards volume information, refer to the standard’s Document Summary page on National Research Council, “Guide for the Care and Use of Laboratory
the ASTM website. Animals,” Washington, DC, National Academy Press, 2011.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F719 − 20
NOTE 1—A vehicle control for liquids is required because of the TABLE 1 Scoring Criteria for Test Reactions
potential for false positives due to skin temperature changes when
Reaction Description Score
handlingrabbit
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F719 − 81 (Reapproved 2012) F719 − 20
Standard Practice for
Testing BiomaterialsMaterials in Rabbits for Primary Skin
1
Irritation
This standard is issued under the fixed designation F719; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice covers a procedure by which the irritancy of a biomaterialmaterial 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.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard may involve hazardous materials, operations, and equipment. 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 safety, health, and healthenvironmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics
3. Summary of Practice
3.1 Exposure of skin to the test material is accomplished by means of a patch test technique employing two intact and two
abraded sites on the back of each of six albino rabbits. three albino rabbits per test article. The skin 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 or semisolids, and a 2.5 by 2.5-cm square
patch for films. After application, each test site is covered with a 2.5 by 2.5-cm gauze flat, and the entire trunk is occluded with
a polyethylene sleeve. After 24 h, the sleeve, flat, and test material are removed, and test sites are evaluated for erythema and
edema.
4. Significance and Use
4.1 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 inexpensivesensitive
method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy
visualization of erythema and edema, which are the cardinal signs of skin irritation.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Oct. 1, 2012April 1, 2020. Published October 2012June 2020. Originally approved in 1981. Last previous edition approved in 20072012 as
ε1
F719 – 81 (2007)(2012). . DOI: 10.1520/F0719-81R12.10.1520/F0719-20.
2
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 the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F719 − 20
5. Materials and Manufacture
5.1 Young New Zealand Albino Rabbits, Healthy young adult albino rabbits of either sex, weighing not less than 2 kg, shall be
3
used. Animal care shall be in accordance with the “Guide for Care and Use of Laboratory Animals”;
5.2 Gauze Flats, 2.5 by 2.5-cm,2.5-cm;
5.3 Polyethylene Sleeves, extra clear, andclear;
1
5.4 Adhesive Tape, ⁄2-in. width.
6. Test Specimen
6.1 The test specimen may be one of three forms:
6.1.1 Test 0.5
...
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